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Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

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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

Amazon Receives 3rd Warning Letter This Year

Distributors are responsible for products they sell

12/27/23

Another Delta 8 Warning Letter

Formats that are favorable to children should be avoided

12/6/23

Improper 483 responses

Re-review online marketing after FDA inspection

11/15/23

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

Seven YouTube Warning Letters This Year

Review old videos for compliance

12/20/23

Eye Care (Ophthalmic) Products Under Increased Scrutiny

Companies are responsible for co-manufactured products

11/29/23

GMP Labeling Lessons

Minor violations can signal the authorities

11/8/23

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

Seven-Year-Old Facebook Post Leads To Warning Letter

Review old social posts for regulatory “landmines”

12/13/23

FTC Letters To Sugar-Promoting Influencers

Influencers must disclose material connection

11/22/23

Printed Brochures Are Labeling

Ensure ingredients are GRAS for the marketed population

11/1/23

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