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.”
However, that efficacy came with what FDA eventually concluded were unacceptable risks, including cardiovascular effects.
The ingredient became associated with a string of serious adverse events, including the high profile death of NFL player Korey Stringer, a lineman who struggled to maintain a playing weight (he was listed at almost 350 lbs). That Stringer was in possession of supplements containing ephedrine alkaloids had been established, but it was not clear whether he had the ingredient in his system when he suffered a case of fatal heatstroke after a hot summer practice session.
Nevertheless, the accumulating evidence led FDA to issue a ruling in February 2004 banning products containing ephedra from the market.
Nevertheless, the warning letter to Princess Lifestyles states that one of the company’s supplements lists Pinellia ternata as an ingredient. This is a plant, sometimes referred to as crow dipper, native to East Asia that has been used as a TCM constituent. The 2004 FDA ban listed Pinellia ternata as one of the plant sources of ephedrine alkaloids. Inclusion of this ingredient makes the product de facto adulterated, the letter states.