FDA raps dietary supplements firms over health claims29 August 2012
The US Federal Drug Administration’s (FDA) latest crackdown on dietary supplement health claims has discovered four firms found to be illegally claiming that their products could cure, mitigate, treat or prevent disease.
In the US and many other countries, such claims are reserved for drugs and not supplements. The four firms - Healing Ways, Dragon Herbs, HSAC Enterprises and Alfa Vitamins Laboratories - have been served warning letters by the FDA. The quartet have 15 days to respond with details of specific steps that they will take to rectify the packaging violations and ensure that similar incidents do not occur in the future.
The FDA found drug claims on Healing Ways' website concerning the company's Silver Colloids, ABC Detox Program and Shell Powder products. Silver Colloids was marketed as “anti-microbial," Shell Powder as able to "kill parasites, bacteria and viruses," and ABC Detox Program as decreasing "acute and chronic symptoms of disease."
Dragon Herbs' website and its Dragon Herbs 2nd Edition Catalog also violated US regulations after claiming that its Activated Minor Bupleurum "demonstrated conclusively to have excellent anti-viral functions in humans with no side effect". The firm's Standardized Scute purported to have constituents that restore "the effectiveness of traditional antibiotics in countering a deadly type of antibiotic-resistant bacterial infection known as MRSA," and its Salacia product was said to normalise blood sugar and insulin levels.
The Administration also found drug claims on Dragon Herbs' promotional materials the agency obtained at the 2012 Natural Products Expo West trade show in California. Several of the company’s dietary supplements were found carry claims relating to cancer prevention or treatment, immune health and miscarriages.
HSAC Enterprises illegally carried claims relating to cold and flu prevention, sinus pain relief, sinus headaches, sexual performance, fibromyalgia and insomnia on its N-Herb, Kold Kare, Energy Kare and Tranquility Kare products. The firm’s website also contravened US regulations and the firm’s promise in a reply to remove the claims from products within 12-18 months was deemed to be insufficient.
Alfa Vitamins Laboratories Inc. was also warned by the FDA after the firm’s Amazon retail store claimed that HIV and depression could be treated respectively with Cat’s Claw and St John’s Wart. The site also said that Gingko biloba extract could be used to treat asthma, kidney and heart disorders and Diabetifen was sold as an effective means of relieving diabetic symptoms.
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