Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
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.)
See Related Warnings:
To read the FDA's warning letter, use the link below.