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FDA Warning Letter Address Faulty Claims Concerns

Continuing their crackdown of faulty claims by dietary supplement manufacturers, officials at the U.S. Food and Drug Administration (FDA) have recently issued several warning letters to those believed to be committing such transgressions. Subsequently, the FDA has been made aware of four dietary supplement manufactures that appear to be making faulty claims about their products. Alfa Vitamins Laboratories Inc., HSAC Enterprises Inc., Dragon Herbs and Healing Ways have each claimed that their products may be used in the curing, mitigation, treatment, or prevention of diseases. Of particular concern, however, is their status as a dietary supplement. According to their claims, these products should be classified as drugs; and are therefore in violation of federal law.

Alfa Vitamins Laboratories, Inc., base out of Florida, received a letter from the FDA on July 12, 2012. According to the letter, officials at the FDA had been made aware of faulty claims made by the company on their website and popular online retailer Amazon.com. Furthermore, the following products sold by Alfa Vitamins Laboratories, Inc. are promoted for conditions that cause these products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]:

  • Sugar Control
  • Aloe Vera
  • Anamu and Llanten
  • CoQ-10
  • Diabetifen
  • Ginkgo Biloba Extract
  • MAX-EPA 2000 mg
  • Noni capsules
  • Noni Juice
  • Omega-3
  • Pulmonary Primacare
  • Shark Cartilage
  • Vitamin E
  • St. John’s Wort
  • Cat’s Claw

The therapeutic claims in English and Spanish on their website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Marketing these products with such claims violates the Federal Food, Drug, and Cosmetic Act.

A subsequent letter was issued to HSAC Enterprises, Inc. based out of Maine. The FDA warning letter they received also acknowledged faulty disease claims made by the company. Several products manufactured by HSAC Enterprises are in violation of the Federal Food, Drug, and Cosmetic Act because of the therapeutic claims on their product labeling. Accordingly, the labels on their products establish that these “dietary supplements” are drugs, due in part to their association for use in the cure, mitigation, treatment or prevention of disease. Those products include:

  • Kold Kare
  • Energy Kare
  • Tranquility Kare

Dragon Herbs, based in Santa Monica, CA, received a similar warning letter following a review of claims made on their website in July of this year. The claims made by the company suggested that their products exhibited “excellent anti-viral functions in humans with no side effects”; “treat MRSA”; and “normalize blood sugar and insulin levels.” However, other claims acknowledge that their products provide treatment to those with cancer, arthritis and obesity problems. Similar to the other letters issued by the FDA, these products are in direct violation of the Federal Food, Drug, and Cosmetic Act. Their products making false claims include:

  • CardioPro 2000
  • Cordyceps
  • Duanwood Reishi
  • Gynostemma
  • Ginseng and Astragalus Combination
  • Dang Gui and Gelatin
  • Sweet Relief
  • Remove Stagnation
  • Bupleurum and Dragon Bone
  • Amolo Tea
  • Activated Minor Bupleurum
  • Standardized Scute
  • Salacia
  • Shou Wu Formulations
  • Ant Essence Capsules
  • Ten Complete Supertonic
  • Super Adaptogen
  • Endocrine Health
  • Supreme Protector
  • Super Pill

The final company to have been issued a warning letter recently was Healing Ways out of Desert Hot Springs, CA. According to the FDA’s warning letter, officials have determined that Silver Colloids, ABC Detox Program, and Shell Powder products are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The claims on their website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of their products with these claims violates the Act.

Do I Have a Dietary Supplement Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in dietary supplement lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by a dietary supplement, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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