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We can learn a lot from warning letters. Following FDA enforcement trends is a valuable tool for any savvy marketer, regulatory affairs professional, quality manager, or dietary supplement executive. We can adjust practices before they elevate to warning letters by learning how to read warning letters and act accordingly. This is why I write the weekly Warning Letter Wednesday post on LinkedIn, Twitter, and Facebook. This blog post is an extended version of my Warning Letter Wednesday posts. This warning letter is a great teaching case. Here are the learning targets. FDA Inspections Trigger Website Reviews Marketing Claims Distributors Responsibilities Common GMP errors *Writing and Following Specifications *Writing Procedures *Product Returns *Product Complaints Certain Herbs Are Not Allowed Common Allergen Labeling Domestic Street Address or Phone Number Languages Must Contain The Same Information Serving Size and Suggested Use Plant Parts Must Be Disclosed Correct Plant Listing Supplement Fact Panel: Line Thickness Percent Daily Values Label Requirement Expiration Dating FDA Inspections Trigger Website Reviews The company was inspected by FDA in March 2021 and was issued several 483s. The company's website was recently reviewed in February 2022, which led to a letter. Learn about the difference between a 483 and a warning letter here. Usually the FDA investigator reviews a company's website for disease claims before an inspection. That is likely still happening but this is the third recent warning letter where FDA inspections led to a website review at a later date. These website reviews were then elevated to a warning letter. I write these letters here and here. This is a fascinating enforcement trend to watch and a good reminder for companies to clean up their website claims if they have been inspected. This is one of my favorite services Supplement Advisory Group offers. Marketing Claims ➡️From warning letter: Although studies (of PS, an ingredient in your product) in humans with Alzheimer’s disease were less dramatic, they still produced significant improvements in cognitive function. In patients with mild dementia, significant cognitive and behavioral enhancing effects were observed. 👉Asa's commentary: These mistakes have been reviewed in previous Warning Letter Wednesday posts; High risk words and video, citing studies, and discussing ingredient benefits. Distributor Responsibilities The company uses a contract manufacturer to make their products. This does not mean the company does not have any GMP responsibilities. ➡️From warning letter: Quality control must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, and you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement 👉Asa's commentary: This means a company has to conduct some type of review and release before selling the product. This does not have to be complicated but it has to be written down and followed. If it's not written down it didn't happen is an FDA mantra. ➡️From warning letter: Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. 👉Asa's commentary: This is boilerplate language but a good reminder that although working with a contract manufacturer does mitigate some risks, the basics of quality assurance should be in place. We discuss many of these topics here. Common GMP Errors Writing and Following Specifications ➡️From warning letter: You failed to have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.140(b)(2) [see also 21 CFR 111.127(h)]. Specifically, your firm distributes the dietary supplements that are contract manufactured for you, but you had no records of a quality control review, approval, or rejection for your finished dietary supplement products. During the inspection, you informed our investigator that you do not review the documentation related to the finished dietary supplement products you receive from contract manufacturers to determine if those finished dietary supplement products have met specifications. 👉Asa's commentary: Not having and following specifications is one of the most common GMP violations. Specifications should be reviewed by a member of Quality and then approved, rejected, or quarantined. This allows problems to be found before products are shipped to the public. I write about this here. Writing Procedures ➡️From warning letter: You failed to establish and follow written procedures for holding and distributing operations, to comply with 21 CFR Part 111.453 that include the requirements for holding components, dietary supplements, packaging, and labels, 👉Asa's commentary: Writing and following procedures is an important part of GMPs. Procedures are the "directions" for doing things, commonly referred to as Standard Operating Procedures (SOPs). Product Returns ➡️From warning letter: You failed to establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements, 👉Asa's commentary: We talk about the requirements for 21 CFR 111 Subpart M (Holding & Distributing) here, and we discuss how to handle a partially damaged shipment here. Product Complaints ➡️From warning letter: You failed to establish written procedures for the requirements to review and investigate a product complaint. 👉Asa's commentary: This is one of the most important parts of being a distributor of dietary supplements. If you are on contact name on the label, you are responsible for reviewing product complaints and informing the FDA of Serious Adverse Event Reports. Certain Herbs Are Not Allowed The FDA does not allow the use of certain plants they consider to be dangerous. Pinellia ternata, a TCM ingredient, was called out in this warning letter because it contains ephedrine alkaloids. Learn more about this here. In general, if a plant is not widely used in commerce, it is a red flag of potential danger, or a New Dietary Ingredient (NDI). Common Allergen Labeling ➡️From warning letter: ..the finished product label fails to declare the specific species of shellfish allergen sources as required. 👉Asa's commentary: The company disclosed the common allergen (crustaceans) but not the type of crustacean (e.g., Contains: shrimp). This is a common error that can be easily prevented. Here are the specific common allergens that need to be disclosed. The specific type of nut (e.g., almond, pecans, walnut, coconut). The specific type of fish (e.g., bass, flounder, Pollack). The specific type of crustacean shellfish (e.g., lobster, shrimp, crab). Domestic Street Address or Phone Number ➡️From warning letter: ..the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 👉Asa's commentary: I review a lot of labels, and it is commonly overlooked. This is how supplement companies track customer complaints and inform the FDA of serious adverse events such as hospitalization Languages Must Contain The Same Information ➡️From warning letter: ..your product labels contain information in two languages but does not repeat all the required label information (including the nutrition information) in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 👉Asa's commentary: I do not review multi-language labels,, so this is a new one to me. There is so much to learn about GMPs. Serving Size and Suggested Use ➡️From warning letter: The “Directions” for your Hemorlyn product states to take “2-4 capsules per day with meals,” but the serving size lists “2 Capsules.” The serving size listed should be four capsules. 👉Asa's commentary: The maximum suggested amount consumed at one sitting is a serving size. For example, a serving size that reads take 1-5 capsules daily is a serving size of 5 capsules, which would need to be in the supplement facts panel. This is an amateur error that could have been prevented. Plant Parts Must Be Disclosed ➡️From warning letter: ..the labels fail to identify in English the part of the plant (e.g., root, leaves) for each of the botanical dietary ingredients in the products, as required by 21 CFR 101.4(h)(1). We note “herb” is not a recognized plant part. Furthermore, we note if an entire or whole plant is used, 👉Asa's commentary: Yes, it really is a rule to list the plant part. Replacing "herb" with "leaf" would be been accurate. This is a great example of what I call a "secondary claim" or a "minor violation" which is something not likely to attract a warning letter on its own/ Correct Plant Listing ➡️From warning letter: ..each product label fails to declare the common or usual name (standardized common name) or Latin binomial of each ingredient used. 👉Asa's commentary: The American Herbal Products Association's (AHPA) Herbs of Commerce is the reference for standardized common names. Thanks AHPA! Supplement Fact Panel: Line Thickness ➡️From warning letter: The Arthrolyn product’s Supplement Facts label fails to separate the (b)(2)- from the (b)(3)-dietary ingredients with a heavy bar. 👉Asa's commentary: Having the correct line thickness is part of a compliant label. Here is an example of correct line thickness and Supplement Fact Panel layout I made just for you. Label review is one on the many aspects of regulatory compliance my company covers. Percent Daily Values Label Requirement ➡️From warning letter: The Goldenlife product’s Supplement Facts label bears the following statement: “Percent Daily Values based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required. 👉Asa's commentary: This is the first time I have seen this in a warning letter, wow. Expiration Dating ➡️From warning letter: Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life 👉Asa's commentary: A company needs to have stability data in order to substantiate expiration, best, before, or freshness dates. Many of the items, such as label formatting and layout issues are not likely to lead to a warning letter. Incorrect label formating however is a red flag that the company is not following the basics of GMP-labeling compliance, and this may be a sign of deeper issues. The quickest way to attract a warning is by making disease claims. This, in combination with serious GMP violations, adds to the risk. The FDA's duty is to protect public safety and not verifying a product's quality may, in some rare circumstances, lead to serious health issues. For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only and does not constitute legal or regulatory advice. Contact an attorney for specific legal advice.

Dietary supplements are great for hydration and liver support, but they cross the compliance line when marketed for hangovers. There have been 14 hangover-related FDA warning letters since the beginning of the pandemic including two this month. This is an enforcement trend that is top of mind for the FDA. Here Are The Learning Targets: FDA’s rationale for hangover being a claim Amazon storefront claims Discussing Ingredient Benefits Are Considered Marketing Claims Referencing Clinical Studies Can Be Looked at as Marketing Implied Claims Will Attract a Warning Letter Blogs Are Marketing Claims Follow Enforcement Trends: What was lower risk yesterday is high-risk tomorrow In the past making a hangover support statement would have been a relatively low risk, but in July 2020 the FDA issued seven warning letters to companies making hangover claims. In the accompanying policy statement press release Steven Tave, former director of FDA’s Office of Dietary Supplement Programs, stated Consumers may get the false impression that using these products can prevent or mitigate health problems caused by excessive drinking. Dietary supplements are not a substitute for responsibly limiting one’s alcohol consumption. Here is my guess as to why the FDA considers the word hangover a claim. Anything that prevents, treats, or cures symptoms of a disease is a medical claim. Amazon Storefront Claims In the past claims made on Amazon were considered "the unholy grail" of compliance, with little enforcement of the egregious claims used to market products. I am glad to see the FDA enforcing this and expect to see many more Amazon-related warning letters in the future. From Warning Letter: Crocin Rich plus is good for: … Help recovery of nerve and traumatic injury....Reduce Hangovers From another Warning Letter: Cure Your Hangover Fast; Milk Thistle … helps speed up the recovery process for your liver, getting rid of your hangover faster!” “Taking the product on a regular basis before drinking may also aid in reducing the possibility of a hangover in the morning. Using words such as cure and symptom demonstrate the intended use of a product to treat disease. It is important to remember the DHSEA disclaimer (Not intended to treat, diagnose, prevent, or cure) when developing marketing content. Here’s a video I made to help companies identify if a claim is being made. If accurate, replacing cure with support and replacing symptom with ailment can help to lower risk. I write about identifying and replacing high-risk buzzwords here. Other possible words for a hangover; imbibe or overindulge. From Warning Letter: Hangovers! Does anybody like them? Not a soul, but how can we stop ourselves from encountering one after a long night? Nutrovape now has the answer. With the new Nutrovape recover, you can make sure your hangovers don't ruin your days after a night of drinking. Discussing Ingredient Benefits Are Considered Marketing Claims From Warning Letter: The “Dihydromyricetin (DHM)” page in the “Health” section of your website: Dihydromyricetin . . . is used for anti-inflammatory, anti-hangover . . . benefits. Research in animal studies suggests several important mechanisms of action relating to DHM’s ability to protect against hangovers: . . . This is a common mistake made by well-intentioned writers and webpage designers that do not understand the nuances of dietary supplement marketing. Best practices here are separating the ingredient benefits discussion from the product page, removing high-risk words, and ensuring that a reasonable consumer will not think this is intended to sell a product. Here is a Warning Letter Wednesday post on this topic. Referencing Clinical studies Can Be Looked at as Marketing From Warning Letter: Research in animal studies suggests several important mechanisms of action relating to DHM’s ability to protect against hangovers. Here is a post and a video about clinically proven types of statements. Although not hangover-related, here is a NAD case decision and FTC administrative compliant that are interesting reads. Implied Claims Will Attract a Warning Letter From Warning Letter: More recently, Dihydromyricetin has received attention for its purported anti-hangover activity. Several studies suggest that it may lower markers of inflammatory liver disorders. Anecdotal reports indicate that this may carry over to alcohol-induced liver inflammation. Stating anecdotal reports indicate then adding a disease word is considered a suggested implied claim. Other examples of this include using “may” and “should” followed a high-risk buzzword. See my post on this here. Blogs Are Marketing Claims Informational blogs are considered extensions of the label. This warning letter references a light implication that CoQ10 is useful for hangover support. This statement was made about the ingredient CoQ10 in an educational blog. The FDA makes the correlation this is a marketing claim because a product sold on this website CoQ10 has the same name as the ingredient. From Warning Letter: Holiday Hangovers: After All That Partying, Which Nutrients Do You Need the Most (which references the ingredient Coenzyme Q10 contained in the product Nanoemulsified CoQ10) The compliance line between "informational" blogs and product blogs is very thin and is open to interpretation. If a company must use informational blogs on a commercial website it is important to make it clear the blog is for educational purposes only and remove all CTA's (Call To Actions) that link to a shopping cart or product page. Here is a detailed Warning Letter Wednesday post and a helpful video I made on the topic. Please share these with your content team as training tools or contact me for a free consultation. I love talking about this aspect of marketing and compliance. Follow Enforcement Trends: What was lower risk yesterday is high-risk tomorrow Earlier this year the FDA cracked down on companies making depression and anxiety claims which I write about here. Anyone who was paying attention to enforcement trends would have removed these words from their marketing, but the warning letters continue. As exemplified by the hangover enforcement timeline, what was a lower risk in the past may be high-risk tomorrow. I love enforcement trends; they give us an opportunity to learn from others' mistakes and course correct. Read my Reasons to Follow Enforcement Trends post for a detailed discussion. Also, reading my weekly Warning Letter Wednesday post or anything by Josh Long or Nathalie Bougenies are great ways to stay up to date with what the FDA is focusing on. For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only and does not constitute legal or regulatory advice. Contact an attorney for specific legal advice.

The popularity of medicinal mushrooms shows me the world is finally ready to embrace natural medicine. It is no surprise however to see mushroom product marketers being called out in warning letters for making high-risk claims. Here's a recent warning letter that covers many of the common mistakes to avoid. Most of this I've talked about here in my blog or my #WarningLetterWednesday LinkedIn post. Here Are The Learning Targets: * Follow Enforcement Trends: Depression & Anxiety Claims Are Super High-Risk *Hashtags Are Claims *High-Risk Words Should Be Avoided *Implying "Clinically Studied" Is High-Risk * Clean Up Claims On Old Social Media Posts * Social Media is Marketing Many warning letter recipients are not bad folks but perhaps just do not know any better. A purpose of my free Regulatory Education Series platform, my public speaking tour, and my free video channel is to educate those looking to raise the bar of ethics and compliance in the industry. Please share this blog or any of my content (with attribution) if it may be of value to your network. We are stronger together! Follow Enforcement Trends: Depression & Anxiety Claims Are Super High-Risk Earlier this year the FDA cracked down on companies making depression and anxiety claims which I write about here. Anyone who was paying attention to enforcement trends would have removed these words from their marketing. I love enforcement trends, they give us an opportunity to learn from other's mistakes and course correct. Read my Reasons To Follow Enforcement Trends post for a detailed discussion. Hashtags Are Claims It is pretty obvious but in this warning letter, the following hashtags were called out. #DepressionAndAnxiety #BeatDepression #BeatAnxiety The quickest way to wave a stick at the FDA/FTC is by using non-compliant hashtags, High-Risk Words Should Be Avoided I have developed a risk-rating system on a scale of 1-5. Here are some examples of words in the 5 of 5 risk categories: cancer, COVID, Alzheimer’s, depression, PTSD, Diabetes should never be used. Words such as pain and inflammation carry a risk level of 3 of 5. For context, anything 3+ is likely to attract a warning letter. Contact me for a list of other high-risk words to avoid with some possible lower-risk alternatives. Here are some tips to know if a claim is being made! I also made a video on this! Implying "Clinically Studied" Is High-Risk This is definitely a trend to watch out for. We are seeing references to clinically studied types of claims showing up not just in warning letters but also in class action lawsuits. A company cannot imply their commercial product has the same uses as a clinical study. We talk about what defines clinically proven here. There are many factors including serving amount, formulation, and delivery size which play a role in this. Here are some egregious examples from the warning letter in grey. On the scientific studies webpage, under the heading “Lion’s Mane Scientific Studies”: • “Lion’s Mane May Be Effective in Combating Dementia/Alzheimer’s Disease” • “Lion’s Mane Has Shown In Studies That It Could Reduce Anxiety And Depression” • “Animal Testing Shows Lion’s Mane Helps Control Diabetes Symptoms By Keeping Blood Sugar Low” This is a good example of a company pushing out content without having a compliance review. I review this and more in this Hiring Supplement Experts for Rapid Company Growth blog post. I loved that post and poured by 20 years of experience into it! Clean Up Claims On Old Social Media Posts The authorities look at a very old social media in the same manner as a current one! In this warning letter, a 2019 tweet is referenced! Please please please, delete or clean up old non-compliant social media posts. I really don't want to tell you I told you so! Read about this in my Operation CBDeceit blog. From the warning letter in grey. Notice the 2019 date! On your social media website • “LVL:MAX . . . Protects Against Ulcers in the Stomach: Goodbye Pain… Relieves Depression and Anxiety… Lowers Cholesterol: Live Longer…Lower Inflammation…” [From a Nov 12, 2019 post] Social Media is Marketing Anything used to sell a product, including all commercial social media posts are marketing, and therefore must be compliant. Most warning letters reference social media I find it helpful to think of all marketing as an extension of the label. We wouldn't use the word anxiety on a label, so it's important to not use disease claims in any marketing, including social media infographics. Anything used to market must be truthful and not misleading. I hope you enjoy this warning letter report from the front line of compliance. I read every FDA warning letter and report back on enforcement trends. I love this aspect of compliance! For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

There is no escape for companies making serious disease claims. The FTC is cracking down on claims made on blogs and social media including Tik Tok. There are four primary lessons to be learned from this FTC action. Blogs can be looked at as marketing. Claims on social media are under increased scrutiny. Clinically proven statements are high-risk and must be substantiated. Disease claims are high-risk. So Why Did The FTC Choose This Company? An FTC official once told me their enforcement actions are a shot across the bow as a warning to the entire industry. This is a clear Marketer Beware Signal as hundreds of CBD companies are still making similar claims. Here is my analysis of the FTC action against six CBD companies in December. The FDA or FTC looks at the 30,000-foot view of an entire website and socials. One claim may not attract a letter or enforcement action, but a disease claim in a video, a claim hashtag on socials, and a testimonial claim can elevate your risk. The authorities piece them all together for one big picture of non-compliance. They like to make examples out of companies not following rules, especially in areas they want to highlight which is what we see in this complaint. There are many common mistakes referenced in this enforcement action. I review many of these in my blog posts Warning Letter Review: What went wrong and how to avoid Compliance Lesson: In-Depth Warning Letter Review. Blogs can be looked at as claims Education is ok but blogs can easily cross the “claims” line when used for the purpose of selling a product. Most of the cited claims in this complaint come from blogs. Here is a LinkedIn discussion about blogs and claims. I moderated an AHPA regulatory panel where we discussed blogs and compliance with a top FTC official. The FTC official would say “Why is a company using blogs on their commercial website if not to sell products”. This is the lens the FTC and FDA look at when reviewing marketing statements. I often use this example when educating about how “informational” blogs can easily cross the line into claims. From FTC Complaint: Excerpt from “CBD Lotions – Do They Really Work?” Kushly (Kushly.com), posted Mar. 24, 2020, https://Kushly.com/blogs/news/cdb-lotion: [CBD] also affects the brain positively, allowing for the minimization of symptoms related to anxiety, depression, and other mental disorders. CBD has also shown some promise with regards to the treatment of seizures as well as neurological problems such as Parkinson’s or Alzheimer’s disease…. Asa commentary: This blog has all the high-risk words we continue to see in warning letters. I am not surprised this was called-out by the FTC. Claims on social media are under increased scrutiny. As marketers look for new ways to reach consumers, the FDA and FTC are paying extra attention to claims made here, This complaint is the first time I have seen claims made on Tik Tok mentioned, and I expect to see more in the future. This is one of the many reasons to follow FDA/FTC enforcement trends. Clinically proven statements are high-risk and must be substantiated. “Clinically proven” enforcement action by the FTC, FDA, and plaintiff attorneys are common in the dietary supplement world and are becoming more common in the hemp product world as well. We discuss this here. Disease claims are high-risk. It is high risk to imply that products treat, mitigate, or cure diseases or health conditions. This is no surprise . We discuss this here. What penalties does the company face? Fines of $30,000+ to be paid within 5 days. Although not commonly reported the administrative requirements are in many ways more onerous than a sizable fine. These include: Contacting all customers who purchased certain products May 26, 2019 through August 27, 2020 See letter below This is not only costly but embarrassing. Provide notice of the FTC order for one year on the web and all social media platforms. Report on compliance and keep records for 10 years. Disclose this order to any new company officers or investors. In my opinion, this could likely hinder any future M&A activity. This is the letter the FTC is requiring be sent: What is the difference between the FDA & FTC? There are differences between the FDA and the FTC although there is much overlap. Here is my oversimplification: The FDA governs the manufacturing and labeling of products (such as food and supplements). In the digital era, labeling has a broad meaning and can mean anything that markets the product. This could be a social media post, hashtag, video, or even an influencer statement. The FTC oversees advertising practices to ensure consumers are not misled. They are one of the good guys in my opinion and protect consumers from everything such as sweepstakes scams targeting seniors, to products marketed with erroneous health benefits for the purpose of material gain. A claim may be allowable by the FTC if not misleading and has met their scientific substantiation standard. This same claim however could be unallowable under FDA regulations as certain claims (disease claims e.g. hypertension) are never allowed. Remember the FDA Disclaimer Not intended to treat, diagnose, prevent, or cure any disease. Are these actions different than a warning letter? This FTC action has a lot more teeth than a warning letter! The FDA and the FTC can issue warning letters, Warning letters are not good and should be avoided as they can alert class action attorneys, require resources to respond to, are a matter of public record, and can scare away investors to name a few. We discuss this in more detail here. If you enjoy this review please share it with your network. Building this content is a true labor of regulatory love! For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

Everyone who knows me is aware of my love of reading warning letters. Gaining insight into enforcement trends can help protect companies from costly regulatory mistakes such as warning letters, administrative action, or even class-action lawsuits (Made in the USA, Natural, THC-Free, Prop 65). Many warning letter recipients are not bad folks but perhaps just do not know any better. One of the purposes of my free Regulatory Education Series is to educate those looking to raise the bar of ethics and compliance in the industry. Please share this blog or any of my content (with attribution) if it may be of value to your network. We are stronger together! We are going to have fun reviewing this Cannafyl warning letter which can work as a teaching case to help you understand what the FDA is enforcing. Here are a few learning topics: Social media is advertising COVID-19 implied claims Hashtags are claims such as #cbdforhypertension Reasons to clean up old social media posts Blog are claims Sublingual claims = drug delivery Quotes from the FDA warning letter are in grey. We have also reviewed your social media websites Asa Commentary Social media is referenced in nearly every warning letter. Anything used to market is looked at as an extension of the product label and must be truthful and not misleading. these websites direct consumers to your website https://cannafyl.com to purchase your products. Asa Commentary This “material connection” aspect is important to note. This is how the FDA links disease claims to commerce. I ask “If there was no linking to a company shopping cart, would these have been noted in the warning letter”. Dietary Supplement Labeling Asa Commentary FDA's boilerplate comments are referenced in CBD warning letters. I will say hemp cannabinoids are not going away and mature companies are looking for ways to comply. Since the FDA regulates based on intended product use is it most ethical and accurate to label ingestible hemp products as supplements? We discuss this here. On your website homepage ….“CBD MAY HELP YOU WITH . . . Epilepsy[,] Multiple Sclerosis (MS)[,] Amyotrophic Lateral Sclerosis (ALS)[,] Parkinson’s[,] Inflammation[,] Dementia[,] Depression[,] Bacterial Infections[,] Diabetes[,] Rheumatoid Arthritis[,] Substance Abuse/Withdrawal[,] Heart Disease[,] Irritable Bowel Syndrome (IBS) . . . ADHD[,] Schizophrenia” Asa Commentary Including the word May does not allow companies to make claims. I moderated an AHPA regulatory panel with a top FTC official. He would say “Asa, why is this company making this statement if not to sell products”. This is the lens the FTC and FDA look at marketing statements. I often use this example when educating about how “informational” blogs can easily cross the line into claims. On your website …. October 10, 2020 blog posting titled “CBD for Breast Cancer”: · “How CBD helps manage Cancer Growth . . . One of the many reasons Cannafyl decided to make a full spectrum CBD product is the research shown that having all of the cannabinoids working together synergistically provides that extra component that cancer patients fear the most, will my cancer return? Here are a few of the cannabinoids in a full spectrum CBD that are working overtime to inhibit cancer cell growth: CBD: Inhibits Tumor Cell Growth and Cancer Growth[,] CBG: Inhibits Cancer Growth[,] CBGv: Kills Cancer Cells[,] CBC: Inhibits Tumor Cells and Cancer Growth[,] THCa: Inhibits Cancer Cells” Asa Commentary This is a clear product cancer claim and is extremely high risk. I am asked whether “helps manage” or “may help support” lessens the risk of making claims. The answer is no, as a reasonable consumer would interpret this as a product claim. I have developed a risk-rating system on a scale of 1-5. Here are some examples of words in the 5 of 5 risk category: cancer, COVID, Alzheimer’s, Depression, PTSD and should never be used. On your website https://cannafyl.com/blog/cbd-for-opioid-addiction-withdrawal/: August 21, 2020 blog posting titled Can CBD Help with Opioid Addiction and Withdrawals?”: · “Can CBD Help Treat Opioid Addiction?” In particular, CBD has been shown to aid in the reduction of drug-seeking behavior. Because CBD may provide relief for a cross-section of symptoms – like . . . mood or anxiety disorders . . . CBD Solutions to Opioid Addiction[,] CBD has been shown to reduce anxiety and control cravings for opioids. . . . Studies have shown CBD may help reduce cravings and reduce opioid withdrawal symptoms. . . . This is why we have decided to create the Cannafyl Relief blend for those who are going through withdrawal symptoms.” Asa Commentary Reasons to follow warning letter trends. Anyone who reads my blog or pays attention to FDA enforcement trends knows that marketing to those suffering from opioid withdrawal is a no-no. We discuss examples here. We also see anxiety (3.5 of 5 risk rating) showing up in more warning letters. Read about this here. On your website https://cannafyl.com/blog/researchers-explore-how-cbd-might-positively-affect-covid-19/: August 12, 2020 blog posting titled “Researchers Explore how CBD Might Positively Affect COVID-19”: · “While researchers continue to explore several ways to fight against COVID-19, some are diving a little deeper to see if cannabis derived CBD could possibly benefit those that are suffering from severe forms of this infection. Further research has suggested that CBD is perhaps able to reduce the angiotensin-converting enzyme 2 (ACE2) expression, which is used as a cell receptor to invade human cells. . . . At Cannafyl we formulated a full-spectrum CBD infused with natural terpenes and essential oils giving you all the health benefits that a CBD product can provide, and the great news is you don’t need that much CBD to receive all of the health benefits. This is why we decided to create the Cannafyl Balance blend for your every day [sic] needs. Asa Commentary The words “could possibly benefit” do not allow a company to make COVID implied claims. Use of "buzzword" Coronavirus. This carries a risk factor of 5 of 5 (Asa's rating system) Here's our webinar on this. Implying the product will be useful for coronavirus symptoms is a bad idea. In the eyes of the FDA/FTC, this may suggest the consumer doesn't need to take preventative action (e.g. masks, hand washing). This is at the core of most COVID warning letters. On your Facebook social media website at www.facebook.com/cannafyl: November 15, 2020 posting: · “CBD FOR HYPERTENSION? Check out this informative article that looks into the benefits of CBD on wellness. https://cannafyl.com/blog/cbd-oil-for-blood-pressure/ #cannafylcbd . . . #cbdforhypertension . . . #hypertension #highbloodpressure . . ..” Asa Commentary I caution against companies sharing articles in high-risk areas, as the line between education and advertising is very thin. Remember the FTC official saying “Why is this company sharing this content if not to sell products”. The risk associated with posting this article is elevated with these hashtags. High-risk hashtags are the quickest way to wave a red flag at the FDA asking for attention. When the company lists #cannafylcbd it is clear they are implying their product is marketed for these diseases. This is a good example of a company pushing out content without having a compliance review. I review this and more in this Hiring Supplement Experts for Rapid Company Growth blog post. On your Twitter and Facebook social media websites at https://twitter.com/cannafyl and https://facebook.com/Cannafyl/, respectively, November 17, 2020 postings: · “I am so glad I found Cannafyl for Pets. I have a puppy at heart (13yr senior chi/mix). Being a small dog she is more prone to arthritis, disk degenerative disease… and luxating patella… Once we got her started on the guided regime within a few weeks we were seeing improvement in her… pain management…” Asa Commentary Reposting or using customer testimonials to sell products is considered marketing, and therefore should not contain claims. Testimonials and product reviews are commonly overlooked. I suggest training your social media staff on the dos and don’ts of testimonials and reviews. I strongly suggest cleaning up old non-compliant social media posts as they can only cause problems. Some warning letters have referenced two-year-old posts! Read about this in my Operation CBDeceit blog. We also note that the labeling for your “Balance CBD Drops,” “Relief CBD Drops,” and “Relax CBD Drops” recommends sublingual administration (under the tongue). The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) of the FD&C Act as a product that is “intended for ingestion.” Because sublingual products are intended to enter the body directly through mucosal tissues, they are not intended for ingestion. Asa Commentary Taking a product under the tongue is a sublingual (drug delivery) claim. I am curious if the directions included “before swallowing” is still considered a sublingual claim. What are your thoughts? I am surprised to find there are still claims on the company website. I immediately noticed seemingly inaccurate Made in the USA statements and customer testimonials which are ripe with claims such as “after using …Pain Salve, my pain level has been greatly reduced.” These can spark plaintiff lawsuits or even follow-up warning letters. Repeat warning letters can lead to serious action such as injunctions. (FDA press release) If you enjoy this review please share it with your network. Building this content is a true labor of regulatory love! For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

I had the great honor of presenting in person at NoCo Hemp Expo last week in Denver, Colorado. After a year of virtual presenting, I was apprehensive about how returning to live presenting in the middle of the pandemic would be. I am glad to say it was ok, and so much fun! I shared the stage with Bob Hoban and Tim Gordon, two industry legends. We talked about FDA regulations and so much more. It felt like three old friends chatting in a living room about important industry issues. It was casual and just perfect! I was asked about how to plan for the future of the hemp industry. I spoke about the importance of conducting safety studies which companies like Burdock Group and NutraSource can help with. We review this here. I also felt it appropriate to share a quote about resilience from my late father Arnold Waldstein. This is my company mantra but also applies to anyone who is struggling to build their career and company during this pandemic era. The main stage was reminiscent of a large concert or Tony Robbins event, with our faces on screens over 30 feet tall. This allowed the presenters to be seen from the spaced-out tables in this huge building. We wore masks while entering and exiting the stage and microphones were sanitized for each individual. I felt very safe and comfortable! Colorado Governor Jared Polis was on the stage shortly after us. I look at this as an endorsement of the safety protocols put into place. I am interested in how events are reopening in a responsible way. NoCo seems to be helping to define this. Many thanks to Morris Beegle, Lizzy Knight, and the rest of the WAFBA family for putting on this huge undertaking. I am in awe of the amount of planning and expense which went into this event! On the show floor, I admittedly initiated several awkward fist-bump/handshake greetings with old friends. We all laughed and smiled from underneath our masks. COVID Guidelines The event required all attendees to fill out health screening and temperature screening before being admitted, and booths were spaced apart. You can read about their COVID guidelines here. It was held at the three-story National Stockshow Complex which is huge! Foot traffic was directed in a one-way direction and there was adequate spacing between all booths. There was plenty of hand sanitizer available and I wore my N95 the entire time except while on stage. Fun Times I even got a chance to take a picture at this booth, which has innovative products combining hemp and non-psychoactive mushrooms such as reishi. We talk about considerations when adding CBD and other nutraceuticals here. What Is the Future of Tradeshows? The event shows how much pent-up demand for human connection and standard tradeshow networking there is. As an avid trade show exhibitor, I have attended over 100 shows and have been reflecting on what the future of trade shows looks like. I can see a future where trade shows are a hybrid approach, with educational and booth “visits” happening both virtually and in-person. Virtual attendance and exhibiting helps lessen the carbon footprint required to travel to trade shows and has cost-savings benefits as well. What virtual does not capture is the chance meetings with an old connection in the hallway or a new client who just happens to be walking in the same direction on the trade show floor. This to me is the core of trade shows and I have built my career developing these impromptu relationships, which I am thankful to say have resulted in great friends and a successful business. I look forward to seeing you in person or virtually at upcoming events. Check out my events page to stay up to date. My regulatory consulting company specializes in analyzing marketing risk in the web, social media, and labels. We then help clients message products in an effective and compliant manner, the fun stuff... Contact me for more information.

Making Disease Claims is "So 2020" Let's all agree that making risky claims should be a thing of the past. The first step is breaking the mindset that in order to sell products risky or spurious claims must be made. Here are some helpful hints on how to advertise in a compliant and effective manner. Tell your company story Sharing your company origin story without making claims is a great way to connect with customers. I prefer video as it deepens the connection. High-quality videos are good but an authentic video shot on a phone is fine too. I do however always suggest captioning videos as most videos watched online are viewed without sound. I use Rev for captioning which costs $1.25 a minute. I recently saw a video founder story where the owner was flyfishing while talking about why he started the company. This creates an authentic human connection and I instantly was interested in their products. Cultivate Authentic Excitement Do your customers and staff love your products? If so, sharing their authentic excitement with pictures is a great way to humanize your brand. Here in Colorado, we have four seasons of outdoor hiking, snowboarding, and camping photo opportunities. This is an example of a made-up compliant and authentic way to state CBD product is great for recovery. Advertising should always be truthful and any material connection (e.g. free product) should be disclosed per FTC guidelines. An easy way to do this is by adding #Sponsored to a post. I suggest developing best practices for social media managers to follow as a well-intentioned employee can easily attract FDA/FTC enforcement attention. For example, a customer may tag a company in a photo that includes a claim such as inflammation. If your company retweets, reposts, likes, or comments on the post, this is considered substantiation of the claim and should be avoided. I review common mistakes in this blog post. Contact me for help in building these best practice documents. Another type of campaign could include asking your customers to post a picture of themselves and why they love your products (without claims). Posts with the most likes receive a charitable donation in the customer's name. These double positive campaigns which include authentic viral growth and good cause philanthropy are some of my favorites. What Sets The Company Apart? Trade association membership with an organization like the American Herbal Products Association (AHPA) shows a company cares about compliance and the long-term health of the industry. Formulations with added safe nutraceuticals such as adaptogens and nervines can increase the formulation efficacy and differentiate it from other products on the market. We review this here. Use caution when discussing individual ingredients as this may be considered product marketing. Be careful with statements attached to your product description such as “Turmeric has a long use as an anti-inflammatory”. We review this and the 9th Circuit ruling on structure-function claims here. Here are common mistakes when marketing supplements & hemp products. Certifications such a B Corp, USDA organic, 3rd party GMP, and US Hemp Authority certification are good markers of culture, quality and differentiate the company from the crowd. I review tips on how to build a company culture of compliance here. A company announcement of self-affirmed GRAS is a clear sign they are invested in their company for the long haul, as future FDA regulations will require a safety component. Learn more about NDIN's and GRAS here and how companies are proving safety here. Bluebird Botanicals in Colorado are doing lots of these important things. This is a sign of a mature company that will be around for many years to come. Congrats! Social program engagement such as meals to front-line workers and social justice organizations is not a marketing strategy, it just makes us human. This is one of the many ways to do good work while staying true to the core principles of humanity. Here is a company Winged Wellness supporting the community while building brand loyalty. This is an example of the "new and conscious business" where having a positive community impact is written into the company's mission. What Are Some Reasons to Avoid FDA/FTC Attention? These include fines, scaring away investors, and class action lawsuits. We review this in my recent Operation CBDeceit blog post and in this video. High-risk Marketing Strategies Are So 2020. If you make great products, support the amazing customer experience, and create an authentic brand identity that connects with customers, your business will succeed. For a free consultation regarding your compliant marketing needs contact me here. Don't forget to clean up those metatags!

The FDA just issued 10 warning letters to companies marketing products for depression and anxiety. These letters include claims made on website product pages, infographics, videos, testimonials, and when discussing individual ingredient benefits. Here are some highlights. Product Names Are Claims This is common knowledge but I was surprised by the brazen claims made in some of the product names. Wholesome Wellness got called out for a product named "Natural Anxiety Depression Relief". As my daughter would say this is OTT (Over The Top). Dr. Garber’s Natural Solutions got called out for products named "Depression Relief" and "Anxiety Relief". Yikes! On the product label, the depression statement is linked to an FDA disclaimer. Although well-intentioned, the disclaimer isn't a "get out of warning letter jail free card", and does not protect from disease claims. I review What Is A Claim here. The Suggested Use also includes dosing for children which is ultra high-risk. The manufacturer should not have applied these. This is another reason to hire a dietary supplement expert. I use a risk level rating system for clients when analyzing the riskiness of different words. Depression has always been 4.5 of 5 due to FDA warning letter enforcement precedent. Anxiety has been 3 of 5, but after these "Big 10" warning letters I have increased to a 3.5 of 5. As a quick aside, anything 3 or more is at risk for warning letter enforcement and should never be used. Interested in learning more? Set up a free consult "About Us" Section: Called Out in Warning Letter "After a tough go-around with postpartum depression, Sylvia decided there had to be a better way to feel better. Her research led her down the rabbit-hole of the gut-brain connection. Her idea for a probiotic specifically designed to help with mood and anxiety was the springboard for Lifted and Mood Boosting Probiotic was their first product." This is a new one for me, although it is not surprising. Lifted Naturals has an origin story in their About Us section. This could have been made lower-risk by removing the buzzwords and not discussing the product (material connection). Suggesting A Product is Better Than Drugs is a No-No Implying consumers should purchase products instead of taking medications is a great way to irritate the FDA into issuing a warning letter. In the eyes of the FDA, what if someone stopped taking their medications and hurt themselves or others. The mission of the FDA is to prevent this. Personally, I am a natural health enthusiast and have my own opinions here, but I keep these to my dinner table discussions. In the Blossom Nature, LLC warning letter they state "St. John's Wort is effective as prescribed antidepressants but with no side effects." Blogs and Testimonials Continue to Show Up In Warning Letters Read all about this here. The picture above is from a presentation over a year ago where I spoke about depression claims. Learning how to read enforcement trends can protect your company. Reasons to Avoid Warning Letters Warning letters are a big deal. I review reasons to avoid letters below and in this video. Ripe Ground For Plaintiff Attorneys Class action lawsuits commonly sprout from warning letters, as attorneys can use the letter as proof of wrongdoing. In the case of FDA Nutrition Inc. and Sleep Group LLC, there are likely incorrect Made In the USA & All Natural claims being made on their websites, and these letters can bring a larger magnifying glass on potential other deceptive marketing claims. We review Made in the USA and All Natural claims here. What Else Can We Learn? Well, we should all know by now that making high-risk claims will attract trouble. I review this in most of my blogs including this post on FTC enforcement. Step #1: Remove all mentions of the depression and anxiety buzzwords from any web or social media presence. This includes metatags and hashtags which are considered advertising. I review this in loving detail here. This includes going back in time to retroactively clean up old Facebook, Twitter, and Instagram posts that may have these, and other claims. Develop ways to ensure these claims don't seep into your marketing. This can be done by having your in-house regulatory expert or consultant review all marketing material before posting. I love helping companies develop in-house expertise. This is literally the reason why I started my regulatory consulting company. Discussing ingredient benefits can be considered a claim, especially when used overtly to sell products. Here is a full webinar on marketing claims. We review compliant marketing strategies here. There is so much to discuss but you get the drift, making claims such as anxiety and depression in any format is bad, and should be avoided. For a free compliant marketing strategy consultation contact me here. I love this stuff! Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

This warning letter is a great teaching case. Learning how to read enforcement trends can protect your company. Here are some of the things I will review. See my comments in red below. *Reasons to clean up old social media posts *Hashtags are claims *Don't market to kids *Don't use the words Coronavirus/COVID (see video here) *Blogs count as claims *Enforcement trends: videos and socials cited in most letters *Implying symptomatic relief for COVID symptoms is bad From Warning Letter: Your blog post titled, “BACK TO SCHOOL: NEW KIDS AND TEEN IMMUNE PAKS” at https://www.hotzevitamins.com/Back-to-School-NEW-Kids-and-Teen-Immune-Paks_b_16.html displays images of your products “Dr. Hotze’s Kids Immune Pak,” “Dr. Hotze’s Teen Immune Pak,” and “Dr. Hotze’s Immune Pak with Vitamins A, B, C, D, Zinc and Probiotics” and includes the following claims: • “The time to start boosting their immune system is now . . . because of the coronavirus . . . Another way to help boost their immune system is with quality vitamins, minerals and probiotics. Take a look at the many health benefits of these supplements:” Asa's Commentary on above Blogs are claims when there is a commercial gain or material connection. This is a great example of a well-intentioned social media manager creating content that is designed to be helpful but is full of claims. See my post here. Children fall into the "vulnerable population" area. Use caution when marketing to them. Use of "buzzword" Coronavirus. This carries a risk factor of 5 of 5 (Asa's rating system) Here's my webinar on this. Implying the product will be useful for coronavirus symptoms. In the eyes of the FDA/FTC, this may suggest the consumer doesn't need to take preventative action (e.g. masks, hand washing) “Vitamin B6 has been implicated in the regulation of immune responses that are associated with a wide range of diseases, including inflammation ….” Asa's Commentary on above FDA enforcement trends show inflammation showing up more frequently. This carries a risk factor of 3.5 out of 5 (Asa's rating system) Use of "buzzword" disease. Remember the FDA disclaimer "Not intended to treat, diagnose, prevent disease". This is at the root of all claims-compliance questions. “Research demonstrates that probiotics are safe and effective for fighting the common cold and influenza-like respiratory infections….” Asa's Commentary on above Use of "buzzwords" cold and influenza. This carries a risk factor of 4 - 4.5 out of 5 (Asa's rating system) On your Hotze HWC website, www.hotzehwc.com, which directs consumers to your website www.hotzevitamins.com to purchase your products: Asa's Commentary on above This is the material connection. If not link or call-to-action to purchase products, this would be lower risk. From your May 26, 2020, blog post titled, “Dr. Erika Schwartz on The Immune System and Coronavirus” at https://www.hotzehwc.com/2020/05/dr-erika-schwartz-on-the-immune-system-and-coronavirus/, which provides a transcript of Dr. Steven Hotze’s interview with Dr. Erika Schwartz and attributes the following statements to Dr. Hotze: • “Dr. Hotze: . . . I was on Fox News on March the 15th, Sunday afternoon, on the coronavirus pandemic report. . . And I talked about the importance of vitamin A, B, C, D and Z with the probiotic, and I made my case and said, ‘Build up your immune system that’s what you need to do. If you have a healthy immune system, you’re not going to have to worry about this virus or that virus or this bacterial infection, you’re going to be healthy. And that’s what you can do and you need to do that now through . . . the vitamins you take . . .’ I mean, the lady looked at me and she goes, ‘We don’t really believe vitamins and all those things can help you with the coronavirus.’ Well of course it can.” Asa's Commentary on above Blogs are claims when there is a commercial gain or material connection. Old social media posts. I strongly suggest cleaning up old non-compliant social media posts as they can only cause problems. Some warning letters have referenced two-year-old posts! I'm sure our opinions on this disease have changed since March 2020 and this post should have been removed. Read about this in my Operation CBDeceit blog. The blog references a transcript from an external site. When the company re-posted they substantiated the claims made, which were quite egregious. Again, this is for the benefit of commercial gain. The connection between an outside interview being substantiated by the company shows the FDA/FTC being clever to piece this together, Here's a webinar where I review this. In a May 27, 2020, post, you link to your May 2020 newsletter titled, “The Coronavirus Fraud: Power, Control and Money” at www.hotzehwc.com/wp-content/uploads/2015/02/Hotze-Healthy-Living-Newsletter-May-2020-1.pdf, which includes the following claims: • “COVID-19 is not the lethal threat it’s made out to be . . . The most important thing you can do is strengthen your immune system . . . Here are my recommendations for strengthening your immune system . . . Asa's Commentary on above Use of "buzzword" Coronavirus. The company implies Coronavirus is not a lethal threat, which goes against CDC guidelines and may suggest the consumer doesn't need to take preventative action (e.g. masks, hand washing). The company then implies purchasing their product protects from Coronavirus. This is a good example of a company pushing out content without having a compliance review. I review this and more in this Hiring Supplement Experts for Rapid Company Growth blog post. “Order Dr. Hotze's Immune Pak with vitamins A, B, C, D, and Zinc – www.hotzevitamins.com/dr-hotze-s-immune-pak.html #covid19 #coronavirus #pandemic . . . #fightdisease . . .” Asa's Commentary on above Hashtags are claims. See my post here. Your post hyperlinks to a YouTube video you posted on March 10, 2020, in which Dr. Hotze states: “The key to preventing yourself from getting the flu or the coronavirus is having a good healthy immune system. Healthy people don’t get disease. So think about the A, B, C, D and Zs of strengthening your immune system. Vitamin A, B complex, Vitamin C, Vitamin D, and Zinc. In order to help you strengthen your immune system, I’ve devised Dr. Hotze Immune Pak. . .” [video entitled “Boost Your Immune System – Hotze Vitamins Immune Pak” at 0:04 – 0:34, https://youtu.be/0gzA3REXw1s] Asa's Commentary on above Enforcement trends: Claims made in videos (and infograhics) are showing up on more warning letters these days. Implying that Coronavirus will not affect healthy people may reduce the likelihood of preventative measures (handwashing, social distancing etc..). This is very high risk. -Use of "buzzwords" Coronavirus -Substantiating the video claims by hyperlinking it (material connection). On your social media websites http://www.twitter.com/hotzehealth/ and www.twitter.com/HotzeVitamins/: In an April 15, 2020, post: 12 Tips to Boost Your Immune System – hotzehwc.com/2020/04/10-way… #covid19 #coronavirus . . . #fightdisease . . .” Asa's Commentary on above Social media claims are cited in nearly every recent warning letter. Hashtags are the quickest way to attract attention to claims being made. Old social media posts should be cleaned up. I mean who looks at a Twitter post from 6 months ago other than the FDA/FTC? This post links to your April 7, 2020, blog post titled, “10 Ways to Boost Your Immune System” at https://www.hotzehwc.com/2020/04/10-ways-to-boost-your-immune-system/, which includes the following claims: o A graphic on the webpage states, “Protect Yourself with DR. HOTZE’S IMMUNE PAK . . . providing the extra protection needed to help ward off infections. . .” Asa's Commentary on above Infographics are showing up in more letters. The morale is, any marketing must be truthful and not misleading. That was a fun teaching case. Any questions or comments please let me know. Warning letters are a big deal. I review Reasons to Avoid Warning Letters here. For a free consultation regarding your compliant marketing or quality system review contact me here. Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

When starting and growing a hemp or supplement company, I always suggest hiring a dietary supplement veteran to have an active management role in the company. They will help you set up systems in operations, quality and compliance. There are many important factors in hemp and supplement manufacturing and having to learn them on your own can hinder your growth in this fast-moving world. cGMPs can seem daunting but supplement experts are familiar with the basics such as: FDA Inspection Readiness, watch my webinar here Controlled entry Label control Component specifications/release Finished product specifications/release Checked and Verified By System What Regulations for CBD? As we know the FDA’s position on hemp-CBD is unclear, this doesn’t mean that no compliance is needed. In lieu of clear FDA guidance, cGMPs for dietary supplements provide a good guideline to address truthful labeling, and quality, there is no reason for the hemp industry to reinvent itself. View this free cGMP Basics for Hemp-CBD Companies webinar here. There are many important regulatory factors in manufacturing and marketing, cGMPs can seem daunting. The supplement and hemp world is moving quickly and having to learn GMP’s on your own can hinder your growth. Dietary supplement veterans have done this before and can give manufacturing or marketing companies a strategic advantage. An ounce of prevention is worth avoiding trouble, Here are reasons to avoid a warning letter or even worse, an FTC administrative action. Key manufacturing & marketing areas where dietary supplement experience can help your company shine! Developing and Implementing Quality systems: Dietary supplement regulations allow room for interpretation. cGMPs are a framework of regulations but this can be sloppy or difficult to translate into actuality. It’s hard to know how to implement in a way that makes sense for your situation and company. I always try to hire from the supplement industry, as the interpretation of the regulations can mean the difference between success and failure in the highly competitive hemp & supplement world. I see this all the time in my consulting business. Operational Systems: This goes hand in hand with Quality Systems. Help support Quality Systems that ensure products are made efficiently at a high-quality standard, but also keep in mind costs such as headcount and opportunity cost for not shipping QC cleared products promptly. I speak about optimizing customer experience here. Marketing Compliance: Communicating a marketing message without inadvertently getting into FDA/FTC and class action trouble is essential for long-term company growth. Watch my Labeling & Marketing Claims webinar here. As companies are looking to gain a competitive edge they are constantly pushing out content. I commonly see companies that have excellent label and manufacturing compliance and are very careful with online marketing campaigns. An unsuspecting company copywriter or social media employee can bring a warning letter by adding the wrong hashtag, infographic, or a well-intended educational post with studies cited. This is indicative of executives coming from industries such as apparel or tech, and not understanding the smaller but important aspects of what pitfalls to avoid. I review this here I suggest company-wide training sessions which include the top execs. This helps weave a culture of compliance into the fabric of the company’s DNA and spreads compliance from within. Read my discussion on this here. 4. Reduce Learning Curve Time: As companies grow, there is always a learning curve to reach operational efficiency. The time saved by not having to learn on the job is crucial in this very rapidly moving hemp and supplement world. A 3-month delay to launch or scale-up can mean the difference between company success or failure. 5. Machinery: Dietary supplement folks know how to look through misleading vendor promises. High output numbers. If you take vendor Maximum Peak Performance numbers as face value this can lead to inaccurate costing information and can affect how much you charge customers. Not factoring in standard filling deviations can severely hurt your bottom line. This happens all the time. It is called armchair operational planning. Machine onboarding time. Despite vendor promises no machinery is plug and play. Machines always take longer than expected to set up and get running well. Those with experience factor this in. Setting a reasonable machinery implementation time is important as requesting objectives that cannot be achieved can set up a culture of eye-rolling, or “never cry wolf” where tight deadlines mean little more than wishful thinking. This in turn hurts morale, thus hurting efficiency. Quality Control: I can't tell you how many softgel machines have been purchased only to learn that making homogenous softgels at scale is difficult. SO MUCH CAN GO WRONG. If you have been around the supplement industry for long enough you have experienced poor quality softgels and know it is not easy to make a lot of perfect softgels on inexpensive equipment. 6. Recruiting: When you hire someone with years of experience, you are not just hiring them, you are also benefiting from their network. This is called network effects and helps a company hire additional positions but also helps with other resources such as ingredient sourcing. To go a little further into Network Intelligence, all recent jobs I’ve found were unlisted or created for me, and came about through my network. So again, when you hire an industry veteran you are benefiting from their career knowledge and the knowledge and strength of their network as well. 7. Network Benefits: Early in the pandemic, I was researching a product development project and the world was changing day by day. I reached out to my network to see how my colleagues were coping with the vitamin C supply chain and what they were seeing with upcoming packaging supply shortages. This helped me plan the production and purchasing plan accordingly. What about hiring from other industries? Generally speaking people from pharma tend to have a stiffer interpretation of the regulations, as we are masters of our reality. There are plenty of excellent people in the pharma industry but generally speaking people from pharma oftentimes lack the flexibility needed in the dietary supplement or hemp industries. A pharma mindset when designing and implementing quality systems can lead to a rigid “interpretation” of the regulations. It is essential to build a robust and well-functioning quality system in place early on, as inefficient practices can become magnified as companies grow, resulting in longer lead times, unnecessary testing, and a silo approach to whole company objectives. This is very common, and I discuss this during my NutraCast interview here. On the other side, folks from the food industry have a steep learning curve to become accustomed to the more robust supplement cGMPs, and care must be taken to ensure regulations are interpreted correctly and effectively. Develop in house regulatory expertise: There are many ways to develop in-house expertise. AHPA webinars and events are a great way to develop in-house expertise. I attribute much of my executive success and my track record of three FDA GMP audits with no 483’s to AHPA education. This is one reason I volunteer so much time to AHPA! Another way to develop in-house expertise is by consulting attorneys when needed. Here are a few attorneys I like. Rend Al-Mondhiry Erica W. Stump Nathalie Bougenies I suggest consulting legal assistance when just starting a business. For example, I know a friend's company who started making a CBD cooling salve with a high percentage of menthol. After they released the product they realized having more than a small percentage of menthol turns a product from a cosmetic into an OTC drug. Consulting an attorney would have helped them avoid this costly error. Also, I like using attorneys as tiebreakers and to help explain the risks associated with certain marketing campaigns as is commonly the case when a CEO or CMO wants to use language I am not comfortable with. GMP’s are a framework of regulations but this can be sloppy or difficult to translate into actuality. There is lots of room for interpretation in the regulations and it’s hard to know how to implement them in a way that makes sense to your company. Here is one example of how two cGMP approaches get the same outcome. Scenario discussion: The regulations state Design manufacturing processes to ensure product specifications are consistently met. This, as many areas of the regulations, leaves room for interpretation, but the goal is to ensure the product is made to specification. Option #1: Hire a full-time member of quality to stand over the packaging line to constantly be checking quality (labels, lot numbers, fill levels, etc). Discussion: There may be companies reading this who are saying Wait I can’t afford to have a Quality employee on the packaging floor full time. That’s OK, you just need to interpret the regulations in a way that makes sense for you! Option #2: Quality staff starts on the line ensuring the bottle fill level is correct, the correct labels are being applied, and the correct product is being used, etc… The Batch Production Record (BPR) can be written so a Packaging Manager or Lead is responsible for in-process checks. Review: The final lot clearance will always be done by Quality. You are getting the same result from each example, but the implementation is different. By putting some Quality responsibility back to packaging personnel pays dividends, as it helps all employees become an extension of the Quality. This reduces the Us-Versus-Them mentality which can happen with Packaging and Quality and helps what I like to call the virtuous operations ecosystem, where all departments are working together for a common goal. This is a good example of why you should hire a supplement executive who understands not just Quality Systems but also Operations. Implementing a quality system from a compliant and operational perspective will help your company grow in a lean and efficient manner. For a free consultation regarding your compliant marketing or quality system review contact me here. Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

Following enforcement trends are important for anyone selling products. This is especially true for those new to dietary supplement marketing and those who use higher risk language in promoting their products. They show us what the guardrails of compliance are and how to adjust our messaging to avoid a warning letter or worse. Every warning letter helps companies fine-tune their marketing message. For example, claims made on Amazon, Etsy, LinkedIn, or podcasts are now being scrutinized. This includes affiliate marketers who receive benefits from referring to other websites for product purchases. I review examples of what not to do here and tips on how to market compliantly here. What is a lower risk today may be a higher risk tomorrow One example is using a hangover support statement which would have been a relatively low risk in the past, but in July 2020 the FDA issued seven warning letters to companies making hangover claims. In the accompanying press release Steven Tave, director of FDA’s Office of Dietary Supplement Programs, stated that “Consumers may get the false impression that using these products can prevent or mitigate health problems caused by excessive drinking. Dietary supplements are not a substitute for responsibly limiting one’s alcohol consumption.” This rationale of the FDA’s thinking should be considered when advertising product benefits, as anything which implies a consumer should not take preventative action is high risk. One extreme example is products marketed for COVID symptomatic care which may infer its a replacement for hand washing and social distancing. Again, anything the FDA/FTC sees as hindering public safety through product promotion is high risk. Here are examples of common mistakes and tips on how to market products. Here are some examples of high-risk claims and here is a post on testimonials and metatags called out in a warning letter. Importance of Developing In-House Expertise The importance of developing in-house expertise has never been more important. I recommend developing at least one in-house regulatory expert or having an on-call consultant who can keep your company up-to-date on pressing issues that affect your company. There are numerous resources for those looking to learn This is one important reason for staying up-to-date on enforcement trends. Since reading every warning letter and lawsuit is a time-consuming process, I suggest finding a source to follow like attorney Nathalie Bougenois, journalist Josh Long, FDA/FTC press releases, and regulatory blogs. AHPA has lots of great free resources cGMP Basics for Hemp CBD Companies Webinar Preparing for FDA Inspections Webinar Hemp Collective Podcast Marketing claims videos Prop 65 videos and documents Ask Me your questions Other webinars and resources on my site For a free consultation regarding your compliant marketing needs contact me here. Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

It should come as no surprise to read of today’s FTC crackdown on CBD companies making deceptive claims. Of the 3000+ CBD companies the FTC chose six to make a clear statement that ongoing noncompliance can be costly. So Why Did They Choose These Six? What Happened? An FTC official once told me their enforcement actions are a shot across the bow as a warning to the entire industry. This is a clear Marketer Beware Signal as hundreds of CBD companies are still making similar claims. The FDA or FTC look at the 10,000-foot view of an entire website and socials. One claim may not attract a letter or enforcement action, but a disease claim in a video, a claim hashtag on socials, and a testimonial claim can elevate your risk. The authorities piece them all together for one big picture of non-compliance. They like to make examples out of companies not following rules, especially in areas they want to highlight which is what we saw today. Lately they have been focusing on COVID, Alzheimer’s, opiate reduction claims, social media posts, and claims made on videos to name a few. In all six complaints there are quite egregious claims and many fall into the vulnerable population category. This is in line with previous enforcement action, another reason to follow FDA/FTC trends. There are many common mistakes referenced in this enforcement action. I review many of these in a recent blog post Warning Letter Review: What went wrong and how to avoid. Although obviously not allowed, these claims and buzzwords continue to show up in product marketing materials. I mostly see this in educational blogs that are clearly written with the intention to sell products. For companies worried about their compliance, a good first step for companies to take it to remove all the buzzwords including COVID from all marketing materials. Don’t forget going back in time to look at old social media posts! In one complaint to Steve’s Distributing, the claims referenced Twitter posts from 2018. As I’ve said before clean up old social media posts, as they provide no current benefits, but the FDA/FTC looks at a two year old tweet in the same context as a current one. There is also an excerpt from a live chat and of course blogs. The moral here is education is good. Education which is deceptive for commercial gain is bad. Has Anything Like This Happened Before in CBD? Yes and no. The most recent serious enforcement action was against Thrive who really shook a stick at the FTC with ongoing serious claims such as cancer. Other than the numerous warning letters which have less teeth, I have not seen such a clear sign of the FTC’s action on CBD before, showing us the FTC is sick of companies saying anything to sell a product. What Is the Difference Between the FDA & FTC? There are differences between the FDA and the FTC although there is much overlap. Here is my oversimplification: The FDA governs the manufacturing and labeling of products (such as food and supplements). In the digital era labeling has broad meaning and can mean anything that markets the product. This could be a social media post, hashtag, video, or even an influencer statement. The FTC oversees advertising practices to ensure consumers are not misled. They are one of the good guys in my opinion and protect consumers from everything like sweepstakes scams targeting seniors, to products marketed with erroneous health benefits for the purpose of material gain. A claim may be allowable by the FTC if not misleading and has met their scientific substantiation standard. This same claim however could be unallowable under FDA regulations as certain claims (disease claims e.g. hypertension) are never allowed. Remember the FDA Disclaimer Not intended to treat, diagnose, prevent, or cure any disease. Are These Actions Different Than a Warning Letter? Yes, the actions announced today have a lot more teeth than an warning letter! The FDA and the FTC can issue warning letters, as we have seen by the hundreds of these issued for COVID related and other claims. Warning letters are not good and should be avoided as they can alert class action attorneys, require resources to respond to, are a matter of public record, and can scare away investors to name a few. We discuss this in more detail here. What Happens Now? Here are just some of the actions which happen now. I also expect class action lawsuits to follow. Each company must pay a fine within 8 days of order effective date. These are up to $85,000. Respondents must notify all identified eligible customers by mailing each a notice Respondents must provide a notice on all of their social media accounts (including any Facebook, Twitter, Instagram, or YouTube accounts) and on the first page of their websites. Such notice must link to a copy of the Order, along with a toll-free telephone number and an email address for the redress administrator. Respondents must report on their notification program (to the FTC) under penalty of perjury: For 5 years from the date of the last dissemination of any representation covered by this Order: 1. All materials that were relied upon in making the representation; and 2. All tests, studies, analysis, other research, or other such evidence in Respondents’ possession, custody, or control that contradicts, qualifies, or otherwise calls into question the representation, or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or consumer protection organizations; And many more administrative, financial, and compliance reporting directives. Here is one of the orders for your bedtime reading. What Can We Learn? There are a lot of obvious points here such as making claims for the purpose of selling products is never a good idea. Claims in marketing may bring small revenue gains, but in the end FTC enforcement action can sink a company. How Can Companies Avoid This from Happening? Clean up old social media posts starting today! Remove claims from all marketing (socials, web, videos, etc.). Here are some examples if you are asking What is a claim? Get educated. Here are lots of free videos and resources which may help. Develop a company culture of compliance. I write about this here. Hire a consultant to help you maximizing sales by minimizing regulatory risks. This requires staying up to date on enforcement trends. Hire a consultant to help you develop compliance best practices and review marketing materials. For further detailed discussion on this I recommend Josh Long's article. He is an expert resource for all things regulatory. For a free consultation regarding your compliance needs contact me here.