Mannatech ordered to stop claims for several products

Posted 06 December 2017

The USA FDA (Food & Drug Administration) has ordered Mannatech Inc. to stop claiming that its “BounceBack” product reduces soreness, helps reduce muscle pain, and provides anti-inflammatory effects and that turmeric (an ingredient in the product) “has long been used . . . to ameliorate inflammation” and ” has demonstrated anti-inflammatory activity.” The warning letter also challenged nutrient content claims for five other products.

The letter also makes these points: “In addition, our inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CMGP) regulations for dietary supplements”. “These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act . . . in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.  Additionally, even if your BounceBack product did not have therapeutic claims which makes it an unapproved drug, this product would be adulterated within the meaning of section 402(g)(1) of the Act . . . in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements”.

“Additionally, your MannaBears, ImmunoSTART, TruSHAPE, and Catalyst products are misbranded” 

The FDA letter states:

We reviewed your BounceBack product label.  We also reviewed your websites at the Internet addresses www.mannatechscience.org and www.mannatech.com in May 2017, and have determined that you take orders there for the product BounceBack. The claims on your label and websites establish that the BounceBack product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov
 
Examples of some of the claims made for your BounceBack product that provide evidence that it is intended for use as a drug include:
 
On the product label:
“Clinically shown to reduce soreness.”
 
On your website www.mannatech.com:
  • “Reduce soreness by taking BounceBack today!”
  • “Helps reduce muscle pain”
  • “Provides anti-inflammatory effects”
  • “BounceBack…ingredients…Reduce joint pain and inflammation”
  • “What is DOMS? It stands for delayed onset muscle soreness….BounceBack capsules can help reduce this soreness when taken daily over time.” 
On your website www.mannatechscience.org:
  • “Turmeric [an ingredient in the product]… has long been used…to ameliorate inflammation….has demonstrated anti-inflammatory activity….”
  • “BounceBack capsules reduced signs and symptoms of DOMS [delayed onset muscle soreness]….can reduce muscle pain….”
  • “helps reduce soreness….supports recovery from soreness…..helps ease soreness related to inflammation….”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 

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