Warning letter cites ephedra inclusion, 18 years after ban


The warning letter was issued to a San Gabriel, CA-based marketer of dietary supplements.  The company, called Princess Lifestyles, LLC, sells its line of dietary supplements online and manufactures them via a contract manufacturer.

Contract manufacturing obligation

This is yet another example of the Agency citing a brand holder for lack of written procedures covering how those products are manufactured by the company’s contract manufacturer.   As the letter states: “To the extent that you contract with other firms to manufacture your product that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution.”

The warning letter also included a laundry list of labelling errors and omissions, including that if a product is labeled in more than one language, all of the pertinent label information, such as ingredient lists, must also appear in both languages.

Ephedra makes a reappearance

But what stands out about this particular case is the mention of the inclusion of an ingredient that the Agency says is a possible source of ephedrine alkaloids.

Ephedra, a common name for such products, was a highly popular weight management ingredient in the late 1990s and early 2000s. One of the reasons for its popularity is that it seemed to work.  A review published in JAMA in March 2003​ concluded “Ephedrine and ephedra promote modest short-term weight loss (approximately 0.9 kg/mo more than placebo) in clinical trials.”


Source link

Leave A Comment

All fields marked with an asterisk (*) are required