FDA WARNING_LETTER - Libido Edge Labs, Llc

The FDA issued a Warning Letter to Libido Edge Labs, LLC, regarding the marketing and distribution of "Natural Progesterone Cream USP with Adrenal Support," "Testosterone Cream Formula FOR WOMEN," "Testosterone Cream Formula FOR MEN," "Total HGH Cream," and "Libido Edge Capsules NATURAL SEXUAL ENHANCEMENT" on their website.

The FDA determined that the website's therapeutic claims cause these products to be unapproved new drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act), as they are intended for disease treatment/prevention or to affect body structure/function. Specific objectionable claims were cited for each product, including those related to bone density, cholesterol, energy, mental sharpness, PMS, menopause, weight loss, pain relief, muscle mass, libido, sleep, and anti-aging effects.

"Natural Progesterone Cream USP with Adrenal Support," "Testosterone Cream Formula FOR WOMEN," and "Testosterone Cream Formula FOR MEN" are considered new drugs under 21 CFR § 310.530 because they are topical hormone-containing products promoted for drug use without FDA approval.

"Total HGH Cream," "Testosterone Cream Formula FOR WOMEN," and "Testosterone Cream Formula FOR MEN" are not considered homeopathic drugs under FDA's CPG 7132.15 because they contain non-homeopathic active ingredients not recognized in the Homeopathic Pharmacope