Many people have a misconception that there is minimal regulation and enforcement for supplement companies. Unlike this misnomer here is another example of a firm that just don’t get it and the actions taken. In a nutshell, they chose to include unlabeled prescriptive medication into the supplement recipe. A huge no no and clearly illegal.

They include a linty of those including actual prescription drugs and other adulterants in their products. The terminology is API known as an active pharmaceutical ingredient. Now before you get too upset keep in mind that this is a very small proportion of the overwhelming number of supplement firms. Another consideration is that many of the letters stem from the use of unvalidated scientific claims. Which can be how they address the properties and claims of their “natural” product ingredients.

During the 2017 year there were 476 warning letters. Most interesting is the amount  of violation regarding both cleanliness and proper manufacturing.  And the top issue …. alteration of the product…. Who said the buyer should be wary ?

bad food and medicines/supplements

So who received the 476 letters in 2017 ?   388 domestic manufacturers received a FDA warning letter  along with 88 international manufacturers.  Not surprisingly the highest percentage were drug and supplement manufacturers leading with 52% of the problems, followed by food & beverage manufacturers at 22%, with a close 3rd, tobacco product Manufacturers at 17%.

Now don’t think for a minute that medical device manufacturers are not part of the problem. They scored at 8% of the warning letters. If theres good news the animal & veterinary product along with the cosmetics manufacturers were each under 1%. (from AssurX) Keep in mind that this may not represent the issues but rather the current enforcement for 2017. There has been different priorities dependent on the politics, outbreaks and other relevant issues.

 

FDA shuts down firm’s supplement sales over presence of APIs

By Hank Schultz

– Last updated on GMT

FDA shuts down firm's supplement sales over presence of APIs
Another dietary supplement manufacturer has been shut down by FDA, in this case for including illicit active pharmaceutical ingredients in its products.

Last week a federal court in Florida entered a consent decree of permanent injunction between the United States and a company called MyNicNaxs, LCC and two principals, owner Chevonne Torres and Michael Brenner, a company officer.

MyNicNaxs distributed weight loss and sexual enhancement products to consumers through two websites. The company also sells a variety of body slimming devices such as corsets and sexual paraphernalia, which are still for sale on the company’s website.

Undeclared APIs not only illegal, but risky

According to FDA, some of the company’s products, which were sold as dietary supplements, tested positive for APIs commonly found in weight loss and sexual enhancement products.

“Marketing products with undeclared active pharmaceutical ingredients poses serious safety risks to consumers. These types of products are particularly concerning because consumers do not know what the products actually contain, and the undeclared ingredients may cause serious, even life threatening, adverse reactions,”​ said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Despite previous warnings, MyNicNaxs continued violating the law. The FDA will continue to take action to protect the American public when companies knowingly violate the law and put consumers at risk.”

Rouges gallery of APIs

According to the complaint filed with the consent decree, FDA tests showed some of the MyNicNaxs products contained undisclosed pharmaceutical ingredients such as:

  • Sildenafil​, the active pharmaceutical ingredient in Viagra.  This ingredient, and the many analogues thereof, have been found in many products aimed at erectile dysfunction. As vasodilators, the undeclared presence of these drugs could harm the health of consumers who are already on blood pressure medications.
  • Sibutramine​.  This weight loss drug was marketed under the brand name Merida before it was withdrawn from the market after clinical data indicated that it poses an unacceptable increased risk of heart attack and stroke.
  • Phenolphthalein​ is a laxative ingredient that the FDA deemed “not generally recognized as safe and effective”​ after studies indicated that it was a potential carcinogen.

The presence of this ingredient (and that of sibutramine) in tainted products is nothing new; as far back as 2009 FDA identified almost 70 products on the market containing these and other illicit APIs​. Sildenafil and its analogues as potential adulterants appears to have come on the agency’s radar somewhat later.

The permanent injunction requires the defendants to cease directly or indirectly distributing any unapproved new drugs or misbranded drugs. MyNicNaxs is prohibited from receiving, manufacturing, holding and distributing any drugs or dietary supplements until they receive a written notification from the FDA stating that they appear to be in compliance with the decree, the FD&C Act, and its regulations, and that they may resume operations.

Long road to injunction

The road that led to the injunction filed against MyNicNaxs had its start more than five years ago, as detailed in a warning letter FDA sent to the company in 2015​.  The company first came into FDA’s crosshairs when a package meant for the company was intercepted in 2013 and found to contain sibutramine and phenolphthalein. In 2014 the company agreed to recall the offending products, but received additional shipments of tainted product later in 2014 and continued to distribute products containing illicit ingredients up to the receipt of the warning letter in February, 2015.  That warning letter did not mention the presence of sildenafil in any of the company’s products.

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Alan Kadish

Dr. Kadish is an unusual physician often referred to as a “doctor detective”. His expertise is the evaluation and treatment of complex disorders, typically after other physicians and clinics have been stumped, is renowned. He provides care for all family members and has additional training in autistic spectrum disorders (ASD) and chronic complex diseases (focused on autoimmune and neurological conditions). If your wanting or needing some answers for your health issues call us at the Center of Health, 541.773.3191 .