Sibutramine cited in FDA warning letter on weight loss products

By Hank Schultz contact

- Last updated on GMT

Image © iStockPhoto / Lecic
Image © iStockPhoto / Lecic

Related tags: Weight loss, Myocardial infarction, Hypertension

It’s been said that the poor will ever be with us. So too, it seems, will undeclared pharmaceutical ingredients, as FDA has issued yet another warning letter to a marketer of weight loss products.

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.

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2 comments

weight loss

Posted by Jamie Alison,

I'd like to add 1 thing. If you don't want to spend a lot of time working out then just do a 7 minute cardio session as soon as you wake up, this can be a great metabolism boost to revitalize you and freshen you up for the day.

For example you can do a 20 second sprint then 20 second jog, alternate that for 7 minutes. Heck, you don't have anywhere to run? Just do it on the spot, anything to get the body moving and the heart pumping!

Be careful in which guides you follow. There are TONS of fad diets and lies. Here's a great weight loss program I used to lose weight and permanently keep it off: http://thehealthspecialists.com

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Epidemic Situation

Posted by James Neal-Kababick,

Unfortunately, this issue continues to be an ongoing problem. As I predicted, with Meridia being removed from the U S market, counterfeit sibutramine is being diverted more than ever to clandestine products masquerading as dietary supplements. It is important to keep in mind that the other issue is the modification of sibutramine into one of the many analogues in an effort to avoid detection. Our laboratory always screens for the suite of compounds and for potential novel analogues and on more than one occasion have found them using proactive surveillance.

I encourage stakeholders to study the new USP<2251> chapter for guidance on how to approach this type of phytoforensic testing. Now that we have the PDE-5i's out we are turning to weight loss drugs for the next iteration of the chapter.

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