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Asa Waldstein

Community, Compliance, Natural Health

Marketing Strategy Compliance √

Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

“Non-Toxic” Claims Require Extensive Substantiation

Safety related product claims attract scrutiny

1/15/25

Refusing FDA Inspection Access

Be nice to FDA investigators & follow inspection SOPs

12/26/24

Fruit Snack Wars

NAD challenge cases explored

12/4/24

Warning Letter Issued for Eye Color Changing Drops

Product reviews are marketing claims

11/13/24

Product Reviews Become Marketing

Don’t engage with risky reviews

10/23/24

TCM Company GMP & Marketing Violations

Learn from other’s mistakes

10/2/24

Product Reviews Become Marketing Claims

Blogs are “labeling”

9/11/24

“Reduce Bloating” Claims Lead To NAD Case

Even lower risk statements can trigger NAD scrutiny

8/21/24

FDA Crackdown on Animal Product Seizure Claims

Amazon compliance still needs improving

1/9/25

GLP-1 Product Receives Warning Letter

Marketing strategies should consider “reasonable consumer expectations” to avoid issues

12/18/24

Lack of Allergen Labeling Leads to Potential Death

Nutrition fact panels must be in a compliant format

11/27/24

GMP Issues

Following SOPs is essential to compliance

11/7/24

Bashing Competitors Can Lead to Challenges

Playful ads can attract scrutiny

10/16/24

Biomarker Claims Enforcement

When will FDA go after “Nature’s Ozempic” claims

9/25/24

Drug Spiked Warning Letters

Disease claims trigger deeper FDA review

9/4/24

Incomplete 483 Responses

Copackers & distributors must comply with GMPs

8/14/24

Product Review Engagement

Trustpilot reviews can be “marketing”

1/1/25

Basics of GMP’s Cited

Functional mushroom products under increased scrutiny

12/11/24

Influencers Must Disclose Material Connection

Free products should also be disclosed

11/20/24

Discussing Ingredient Science

Discussing ingredient benefits is "marketing"

10/30/24

Goat Milk Company Infant Formula Claims

Well intentioned marketing claims can turn products into high-risk regulatory categories

10/9/24

Best Practices For Using Clinical Study Citations

Do not over-explain clinical research

9/18/24

Marketing Claims Turn Cosmetics Into Drugs

Cosmetics are not "FDA-approved"

8/29/24

Website & Social Claims Lead To Warning Letter

Flu & virus claims are enough for regulatory action

8/7/24

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