FDA WARNING_LETTER - Cosmed Labs, Inc.

The FDA issued a Warning Letter to Cosmed Labs, Inc. following a review of their product websites and labeling for "AIM Renewed Balance Body Cream," "Products of Nature Natural Woman Progesterone Cream," "Products of Nature Relevamine GS," and "Dr. Janet's Glucosamine Cream." The FDA determined these products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The products are classified as drugs due to claims of treating, mitigating, or preventing disease, or affecting body structure/function. Specifically, the progesterone-containing creams are unapproved new drugs under 21 CFR § 310.530 as topical hormone products. "AIM Renewed Balance" and "Dr. Janet's Glucosamine Cream" are also new drugs due to their unapproved transdermal delivery systems. "Dr. Janet's Glucosamine Cream" is further cited for containing ingredients not included in the OTC External Analgesics Tentative Final Monograph and for indications (fibromyalgia, carpal tunnel) not covered by the OTC Drug Review.

All products are misbranded for failing to establish adequate indications for use, not differentiating between active and inactive ingredients, and not adhering to drug labeling format requirements (21 CFR 201.66). Additionally, "AIM Renewed Balance," "Products of Nature Natural Woman Essential Body Cream," and "Dr. Janet's Dual Action Transdermal Gl