Warning Letter Wednesday

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

Do not over-explain clinical research

Cosmetics are not "FDA-approved"

Flu & virus claims are enough for regulatory action

Unsafe products marketed to children are deceptive

Blogs can be considered marketing

Sponsored children’s content has increased disclosure requirements

Only use permitted dietary ingredients or face regulatory issues

Learn from other’s mistakes

Blogs are “labeling”

Even lower risk statements can trigger NAD scrutiny

Specifications continue to be cited

Food safety plans should be comprehensive

Email newsletters are marketing

Incomplete 483 responses lead to warning letter

Marketing in all languages should be compliant

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

Disease claims trigger deeper FDA review

Copackers & distributors must comply with GMPs

Incomplete 483 responses turn into warning letters

Review of NAD case

Reduce litigation by following labeling rules

Study design must be correct

Ensure material connection is disclosed properly