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Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

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Nutrient Content Claims Guidance

Reduce litigation by following labeling rules

6/13/24

Clinically Proven Claims Lead To Scrutiny

Study design must be correct

5/22/24

NAD Case: Influencer Material Disclosure

Ensure material connection is disclosed properly

5/1/24

Topical Product Claims Turn Magnesium Oil Into Drug

All marketing is “labeling”

4/10/24

NAD Case: Sustainability & Clean Ingredient Substantiation

We can learn a lot from NAD cases

3/20/24

"Forgotten" Old Social Media Posts

Old posts are "active" marketing

2/28/24

Lessons From NAD Decision

Clinical study parameters must match claims

2/7/24

Lessons From Inflammation Warning Letters

Inflammation + arthritis claims = warning letter

1/17/24

Sponsored Video Disclosures: Found Incomplete

Sponsored children’s content has increased disclosure requirements

6/5/24

Unauthorized NDI Leads To Warning Letter

Only use permitted dietary ingredients or face regulatory issues

5/15/24

Major Allergen Labeling Issues Lead To Warning Letter

Packaging procedures prevent labeling issues

4/24/24

Social Media Disease Claims Earn Warning Letter

Review old social posts

4/3/24

Undeclared Allergens Lead To Recalls

Advisory labeling is not a replacement for allergen control program

3/13/24

Tips For Understanding What A Claim Is

Arthritis claims attract scrutiny

2/21/24

OTC Drug Website Claims

Websites are considered “labeling”

1/31/24

15 CBD & Delta-9 Warning Letters in 2023

Old blogs & posts are “active” marketing

1/10/24

GMP Labeling Lessons

Incomplete 483 responses lead to warning letter

5/29/24

Disease Claims Lead To Warning Letter

Marketing in all languages should be compliant

5/8/24

Arthritis Claims Enforcement

Learn from other’s mistakes

4/17/24

Warning Letter Marketing Lessons

Learn from other’s mistakes

3/27/24

GMP Lessons For Distributors

Distributors must comply with some GMP requirements

3/6/24

Puffery Claims Explored

Do's and don'ts of puffery

2/14/24

Suggestive Words Like “May Help” Do Not Allow Risky Marketing Claims

Implied marketing statements should be compliant

1/24/24

FSMA Compliance Lessons

Product tags are marketing claims

1/3/24

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