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:
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.
