Posted October 25, 2016

FDA Warns Maker of Sublingual Melatonin and Progesterone Cream

On October 12, 2016, the FDA issued a warning letter to Threshold Enterprises, Ltd. (manufacturer of Source Naturals supplements), following a facility inspection which found the company's products to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish finished product specifications for each dietary supplement manufactured for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, as required by federal regulations.

In addition, the FDA noted that Source Natural's sublingual melatonin products are not dietary supplements because they are taken sublingually - made to dissolve under the tongue rather than swallowed. Dietary supplements must be intended for ingestion. Similarly, the FDA noted that Source Naturals Progesterone Cream was not considered a dietary supplement, as it is applied topically.

The FDA considers these products to be drugs based on how their labels describe their use, but since neither product has been submitted and approved by the FDA as a drug, they are considered "unapproved drugs".

(See Are lozenges and sublingual pills considered dietary supplements? for more about this.)

Also see ConsumerLab.com's Reviews of Melatonin Supplements and Menopause Supplements and Progesterone Creams for tests of related products.

See Related Warnings:

Seller of Sublingual Vitamins Warned for Drug Claims

Seller of Herbal Formulas for Cholesterol, Prostate & More Warned For Drug Claims

Seller of Vision Supplements Warned for Drug Claims

Maker of Vitamin K, Vitamin A & More Warned for Manufacturing Violations, Drug Claims

Seller of "Hangover" Supplement Warned for Manufacturing Violations & Drug Claims

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below.