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FDA Takes Action against Two Companies for Illegally Marketing Supplements as Drugs

FDA issues two warning letters to companies for allegedly violating the Act.

FDA issues two warning letters to companies for allegedly violating the Food, Drug & Cosmetic Act.

NaturalDoctor and Biomedic Labs Rx have recently been sent warning letters from regulators at the U.S. Food and Drug Administration (FDA), claiming that at least some of their advertised claims violate the Federal Food, Drug, and Cosmetic Act (Act).

Specifically, federal authorities have taken issue with the fact that NaturalDoctor and Biomedic Labs Rx have marketed their supplements as treatments, cure-alls or preventative medications despite the fact that none of these supplements has been FDA-approved for the advertised uses.

NaturalDoctor’s Violations

As the FDA explained in its warning letter to NaturalDoctor, federal regulators initiated an investigation into the company in October 2015, with a specific focus on reviewing how the company was advertising the following products:

  • NaturalDoctor Vitamins C & K3 / 100:1TM
  • NaturalDoctor Goldenseal & Echinacea PlusTM
  • NaturalDoctor Centella Skin and VeinsTM
  • NaturalDoctor Organic Artemisia PlusTM
  • NaturalDoctor Organic Dong Quai PlusTM
  • NaturalDoctor Organic Dandelion PlusTM
  • NaturalDoctor Vitex PMSTM
  • NaturalDoctor St. John’s Mood PlusTM

This investigation revealed that NaturalDoctor basically advertises its supplements as “drugs,” which constitutes a violation of the Act. Some of the specific findings the FDA noted in the warning letter included that NaturalDoctor:

  • Made drug treatment claims that are illegal without the agency’s approval, such as for example, that its supplements treat cancer, headaches, gastrointestinal infections, arthritis, kidneys, etc.
  • Misbranded its products because “their labeling fails to bear adequate directions for use.”
  • Failed to “meet Current Good Manufacturing Practice (CGMP) requirements” in preparing, packing and/or storing its products.

Biomedic Labs Rx’s Violations

Biomedic Labs Rx is in a similar situation as NaturalDoctor, as the FDA warning letter sent to this company at the end of last month pointed out some of the same violations NaturalDoctor is alleged to have committed.

In particular, federal regulators were focused on the following products sold by Biomedic Labs Rx:

  • Serracor-NK
  • Serra Rx80
  • Serra Rx 260
  • N-Acetyl Rx
  • Vitamin D3 Rx.

The investigators found that Biomedic Labs Rx also made misleading claims about how the above supplements can treat certain conditions, such as asthma, blood clots, inflammation, scar tissue, etc., despite the fact that these “products are generally not recognized as safe and effective” for such uses.

Whether NaturalDoctor and Biomedic Labs Rx r take action to get into compliance remains to be seen. As more updates become available, we will report the latest news in a future blog. Until then, share your opinions about this blog with us on Facebook.

Contact a Los Angeles Consumer & Class Action Lawyer at Broslavsky & Weinman, LLP

If you believe that you purchased any supplements that made false claims about treatment of disease or their supposed benefits, contact a Los Angeles consumer & class action lawyer at Broslavsky & Weinman, LLP. You can call us at (310) 575-2550 or email us using the contact form on this page.

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