In the letter to Ultimate Weight Loss Co. the agency alleges that three products marketed by the firm contained undeclared sibutramine and phenolphthalein. The three products, labeled “Jenesis,” “Prime,” and “Propell Platinum,” are among the weight loss products that Ultimate sells on its website. The company claims to base its products primarily on the benefits of bee pollen.
Sibutramine is an appetite suppressant drug formerly marketed in prescription form under the brand name Merida. The drug was last manufactured legally by Abbott Laboratories, and was taken off the market in 2010 because FDA determined it presented an unacceptably high risk of heart attack and stroke. Despite this regulatory action, sibutramine has been showing up in the intervening years in weight loss products fraudulently marketed as dietary supplements.
Phenolphthalein was at one time commonly used as a laxative, until research done starting in the late 90s suggested the substance raised the risk of various cancers. The agency said it is not a component of any approved drug in the US. It is often paired with sibutramine in fraudulent weight loss products, with the pair having been mentioned in at least four FDA warning letters in recent years.
"A continuing problem"
“It is surprising and depressing that this continues to be an issue,” attorney Ivan Wasserman told NutraIngredients-USA. Wasserman is a managing partner in the law firm Manatt, Phelps & Phillips. “There seems to be a continuing problem of smaller players having supplements that contain pharmaceutical ingredients.”
Some aspects of the current case will be familiar to any dietary supplement industry observers who follow warning letters. As is the case with many warning letters of this sort, the companies involved are usually entirely unknown to the wider supplement community until they are mentioned in the official communication. Ultimate Weight Loss Co., based in Orlando, FL, is one such firm. Efforts to contact the company were unsuccessful and, while the website is still active, it's unclear if the company is still in business.
Public notifications filed on products
What is unusual about this warning letter is that the three products in question were also the subject of FDA consumer notifications filed in mid December, 2015. At that time, the agency warned consumers that the products pose “a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.”
The warning letter, which was recently posted, was dated April 14, 2016, almost four months to the day after the public warnings were issued. The warning letter was based on FDA’s laboratory analysis of the products; no site inspection results or reviews of labeling or health claims is mentioned.
Wasserman said that the slowness of FDA’s response in such cases can sometimes be frustrating to industry critics. But the warning letter process has a number of steps, including an internal legal review, and companies have a time frame in which to respond.
“The public notifications are not a separate action against the company. Consumers don’t typically read warning letters so FDA has the ability to publicize safety issues in a manner targeted toward them. It is somewhat surprising in this case that there was such a lapse of time between the public notifications and the issuance of the warning letters. It may be that FDA wanted to protect the public immediately without waiting for the warning letter to go through its channels,” Wasserman said.