Warning Letter Wednesday

Comparison to drugs is high risk

“Arthritis” claims elevate risk

All claims should be substantiated

Claims in hashtags, videos, and testimonials should be avoided

Webinars are “fair game” for enforcement

Hire experts to help with 483 responses

Nutrient content claims must be compliant

Expect arterial health claims to be cited in the future

Product names are marketing

Ensure ingredients are lawful for supplements

All dietary ingredients must be tested for identity

Printed catalogs must be compliant

Scan marketing for “mid-risk” heart health claims

Key GMP learning opportunities explored

FDA will test suspicious products for drugs

Study citations are marketing

Ensure weight loss products are tested for drugs

Re-review marketing if FDA has inspected you

Use qualified reference samples

Remove testimonials with claims

Old social posts are “active” marketing

Learning from other’s mistakes is a good strategy

Remove COVID claims including on YouTube

Discussing ingredient benefits is marketing