Warning Letter Wednesday

Formats that are favorable to children should be avoided

Re-review online marketing after FDA inspection

Batch records should be complete

Blogs are marketing statements

Ensure vendors are properly qualified

Homeopathic products under increased scrutiny

Repeat warning letters can have serious consequences

Product formats & packaging should not appeal to children

Companies are responsible for co-manufactured products

Minor violations can signal the authorities

Use AHPA's Herbs of Commerce

Test ingredients for common adulterants

Small labeling issues increase warning letter risk

Re-review online marketing if inspected by FDA

Biomarkers claims elevate enforcement risk

Review videos for compliance concerns

Influencers must disclose material connection

Ensure ingredients are GRAS for the marketed population

Learn from other’s marketing mistakes

Re-review websites if inspected by FDA

Learn from warning letter enforcement

Test products like glycerin for adulterants

Kratom companies should be aware

Test “sketchy” products for adulterants