Pharmaceutical

FDA sends warning letter to dietary supplement maker regarding erroneous claims

supplement Jack3d 280x210 FDA sends warning letter to dietary supplement maker regarding erroneous claimsThe Food and Drug Administration (FDA) has issued a warning letter to a dietary supplement manufacturer Mc-Cor, LLC, because its promotion of “ClucoCoR” capsules makes claims to treat type 1 and 2 diabetes and other conditions, a clear violation of the Federal Food, Drug and Cosmetic Act.

The product was sold on the company’s website www.metacorlic.com/en, touting claims such as:

  • “Promote healthy glucose levels”
  • “Promote… tissue repair”
  • “GlucoCor is a Metabolic Corrector”
  • “Helps maintain adequate levels of blood sugar”
  • “Attends the biochemical origin of the disease”
  • “Treatment for Diabetes 1 and 2 diabetes GlucoCor”
  • “Metabolic Correction for Diabetes Type 2 and Diabetes Type 1”

The agency also called out the company’s link to social media with its Facebook page making claims that “provides further evidence that your ‘ClucoCoR’ product is intended for use as a drug” with posts that claim the product is a “metabolic corrector” that “promote(s) healthy glucose levels.”

The Facebook page also claims “GlucoCor active ingredients could help to lower glucose levels in blood and improve neuropathic symptoms such as pain, burning and numbness of extremities.”

The FDA is requiring the company to respond in writing within 15 working days with specific steps it has taken to correct the violations noted.

The FDA has cautioned consumers repeatedly that dietary supplements should not be used to treat medical conditions. Doing so only delays medical treatment, which in some cases can be life threatening.

Source: FDA