top of page

Asa Waldstein

Community, Compliance, Natural Health

Marketing Strategy Compliance √

Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

Records Refusal Leads To Warning Letter

Take FDA inquiries seriously

2/19/25

"Promotes Brain Health” Claim Challenged

Small words can drastically increase claim risk

1/29/25

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

Environmental Claims Increase Scrutiny

Ensure ESG claims are substantiated

2/12/25

Incomplete Batch Records & Ingredient Specification

Ensure 483 responses are complete

1/22/25

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

GMP Labeling Lessons

Small issues signify deeper noncompliance

2/5/25

“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

bottom of page