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:
- “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.”
- “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….”