Cancer Claim Warning: Health & Wellness Industry News Roundup

摘要

Northern Health Products trips on drug claims; metabolic syndrome patients' bodies hide vitamin E; and multi- micronutrients during pregnancy benefits children's cognitive abilities. Nor thern Health Produc ts Inc . makes cancer and AIDS/HIV treatment claims for its dietary supplement products containing ingredients including thiamine, alpha lipoic acid and N-acetyl L-cysteine, according to an FDA warning letter to the Loganville, Ga., firm. The name of one product containing sodium dichloroacetate and thiamine vitamin 81, branded as DCA Cancer Treatment Kit, is itself a noncompliant claim, FDA's Office of Regulatory Affairs Atlanta District said in the Dec. 22 letter. The firm's website also says the product "can be an effective tool in shrinking tumor size and mass, reversing illness, and increasing health and vitality of patients." ORA's review of Northern Health's website also found claims that its DMSA Synergy product contains the active pharmaceutical ingredient in an FDA-approved drug as an aid in the scintigraphic evaluation of renal parenchymal disorders and a second drug ingredient to treat lead poisoning in pediatric patients, rending the product an unapproved new drug. The firm also made claims for its products including treating heart disease, chronic bronchitis, cystic fibrosis, asthma, sinusitis and pneumonia, according to the letter. FDA posted the Northern Health warning letter a week after warning consumers about a product marketed as a supplement but making claims to treat all forms of cancer. (Also see "Sunset Naturals Recall, Cancer 'Supplement' Warning: Health & Wellness Industry News Roundup" - Rose Sheet, 16 Jan, 2017.)