FDA Commissioner Attempts to Curb Regulated Drug Use in Nutritional Supplements

With an ongoing rise in nutritional supplements containing chemicals regulated as drugs, the Commissioner of the Food and Drug Administration recently sent a letter to all manufacturers of dietary supplements reminding them of their concern of this matter and their plans to reduce the problem.

The purpose of the letter is stated as to “address the significant public health problems posed by products that are marketed as dietary supplements but that contain the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs, or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.”

The letter states that the FDA has received numerous reports of serious adverse events associated with consumer use of those FDA-approved ingredients, which are generally undeclared in the labeling, that are being included in dietary supplements without warning to consumers. These adverse events include strokes, acute liver injury, kidney failure, pulmonary embolisms and death.

The FDA has been investigating supplements in order to discover whether or not they include ingredients that are deemed to be FDA-approved drugs. The areas in which the FDA found the highest rate of products marketed as dietary supplements but containing hidden ingredients include products for weight loss, sexual enhancement and body building. This includes a recall of more than 70 products marketed for sexual enhancement, 40 products marketed for weight loss and more than 80 products marketed for body building.

Although warning letters and recalls have been the primary source of action by the FDA, the letter states that the government may initiate criminal investigations to hold accountable those who violate the Federal Food, Drug, and Cosmetic Act and endanger the public. The letter makes sure to point out that individuals, not just companies, can also be brought up on charges when it states “Responsible individuals, even if the individual did not participate in, encourage, or have personal knowledge of the violation, can be criminally prosecuted under the Act.”

The FDA’s recommendation in this letter is that all firms that manufacture, import, distribute, or sell dietary supplements understand and investigate their full supply chain and review their manufacturing and quality assurance activities to ensure the lawfulness, quality and safety of their products. The FDA also encourages the industry to report any suspected tainted supplements and has offered an anonymous reporting method.

The FDA is hoping that this letter is spread widely throughout the industry in order to eradicate the use of chemicals regulated as drugs in nutritional supplements. It is also seeking continued input from people within the industry to help strategize a way to combat this problem.

To read the letter, click here.

About 

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

Related posts

6 Comments

  1. herbs daily said:

    The FDA has been investigating supplements in order to discover whether or not they include ingredients that are deemed to be FDA-approved drugs.

    Very Right decision indeed

  2. Chris John said:

    Any supplement manufacturer who adds hidden FDA-approved ingredients into their products bring down the reputation of the industry. I sell weight loss and bodybuilding supplements in my health food shop. I private label using a supplement manufacturer who has a GMP-certified facility. That way I can be sure that I am getting a product that meets FDA specifications and conforms to GMP guidelines. It is certainly worth the extra cost – better than having your product recalled. I would also recommend that retailers get their products tested periodically through a third-party lab.

  3. Reh Herbal said:

    This is good news because there are lots of food supplement out there. People should be conscious about the contents of the food supplement they will buy and later take.

  4. William Oliver said:

    I can’t wait for the FDA to step in and get these cowboys out the nutra space. We have been manufacturing according to FDA regs for 20+ years and the last 5 or so we have been hammered with competitors providing products with all sorts of api’s as nutritionals. im not even a complaining old timer yet, but i feel like one lately! Thanks for the data.

  5. Suplimente alimentare said:

    I’m not sure if this is the way to go – “The FDA is hoping that this letter is spread widely throughout the industry in order to eradicate the use of chemicals regulated as drugs in nutritional supplements.” – I don’t think the boys will let go of their “succesfull” business due to this letter. We’ll see

Top