August 28, 2012
IRVINE, Calif.FDA sent warning letters to four dietary supplement companies for claiming their products could cure, mitigate, treat or prevent disease, which are drug claims and illegal for supplement companies to make.
FDA found drugs claims on Healing Ways' website in regard to the company's Silver Colloids, ABC Detox Program and Shell Powder products. Silver Colloids was promoted 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." FDA also noted testimonies also violate the law as they promoted the products as drugs. One testimony said Silver Colloids was able to heal skin lesions, and another said it cured diverticulitis and ulcerative colitis. Another testimony said ABC Detox Program stopped irritable bowel syndrome (IBS). Beyond claims, FDA warned Healing ways that its facility needs to registered with the agency.
Dragon Herbs' website and its " Dragon Herbs 2nd Edition Catalog" also had problematic claims, FDA warned in a separate letter. Website claims said company's Activated Minor Bupleurum "demonstrated conclusively to have excellent anti-viral functions in humans with no side effect," its Standardized Scute was said 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 was promoted for normalizing blood sugar and insulin levels.
FDA also found drug claims on Dragon Herbs' promotional materials the agency obtained at the 2012 Natural Products Expo West trade show, March 8 to 11, 2012, Anaheim, CA. These said CardioPro 2000 [C]an help lower LDL (bad cholesterol)," Cordyceps has "strong anti-tumor activity," Duanwood Reishi plays "an important role in attacking cancerous cells," Ginseng and Astragalus Combination [H]elps to restore immune function in those who havedeveloped chronic disease," and Dang Gui and Gelatin "can be used by women prone to miscarriage and habitual abortion."
HSAC Enterprises Inc. dba Kare-N-Herbs had claim problems on both its website and product labels, according to another warning letter.FDA inspected Kare-N-Herb's York, ME, facility on March 26 to May 1, 2012, and reported the label for Kold Kare had the claims, Prevents Colds & Flu" and Relieves Sinus Pain;" the website had a personal testimony that said Kold Kare reduced sinus headaches. Labels for Energy Kare said the product Improves sexual performance," and the website had a testimony that said Energy Kare improved quality of life in a fibromyalgia patient. And Tranquility Kare's label said it can reduce insomnia and joint inflammation.
In its warning letter to HSAC Enterprises, the agency noted the company sent a response saying it would remove the medial and unsubstantiated claims from the website within 60 days. However, FDA said as of Aug. 1, 2012, the claims were still online. Further, FDA said the company's response regarding product labeling was inadequate because it would take 12 to 18 months to change them, a timeframe FDA finds to be too long.
FDA also noted Alfa Vitamins Laboratories Inc.'s website and its online Amazon store promoted several products using drug claims in both English and Spanish. The company's website said AIDS (HIV) could be treated with Cat's Claw and that St. John's wort was "Helpful for depression." Ginkgo biloba extract is helpful for asthma, kidney and heart disorders, claimed the website, and the product Diabetifen was promoted as helping relieve diabetic symptoms. FDA said the company also had drug claims for shark cartilage, anamu, llanten, noni, vitamin E, coenzyme Q10 (CoQ10), omega-3s, aloe vera and the products MAX-EPA 2000 mg and Pulmonary Primacare.
FDA added the name of the product Alfa's Sugar Control/Blood Sugar establishes the intended use of it as a drug, and said the website's metatags included illegal drug claims, such as "cholesterol lowering supplements," "herbs for high blood pressure," "reduce your blood pressure," diabetes relief," "diabetes," "blood sugar supplement to regulate insulin," and "anti-cancer herbs."
FDA gave each company 15 working days from the receipt of the warning letters to respond to FDA with specific steps to correct the violations and to ensure that similar violations do not occur. The responses need to include documentation necessary to show that correction has been achieved, FDA said.
Supplements are not drugs, and they cannot claim to treat, mitigate, cure or prevent diseases. Supplement marketers cannot make these claims on websites, labels or promotional materials distributed at trade shows. Marketers can also not promote testimonies that have these types of drug claims in them.
Supplement companies are allowed to make structure/function claims and are allowed to make certain FDA-approved health claims for specific ingredients. However, if a company has any doubt about its marketing, it should consult with a industry-savvy legal team. If not, an FDA warning letter could come spurring unwanted attention, and a huge cost replacing labels and updating websites.
Join Rend Al-Mondhiry, Esq., regulatory counsel, Council for Responsible Nutrition (CRN), and Kathleen Dunnigan, Esq., senior staff attorney, National Advertising Division, Council for Better Business Bureaus at 12 to 12:50 p.m. on Wednesday, Nov. 7 at SupplySide West to learn more about "Truthfully Advertising Your Dietary Supplements: Advertising Claims, Evidence and Self-Regulation."
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