FDA issues warning over unapproved OTC chelation products
SILVER SPRING, Md. The Food and Drug Administration on Thursday warned eight companies that their over-the-counter chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products, the FDA confirmed.
The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions. Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy.
The drug products involved have not been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug and Cosmetic Act. Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care.
In addition, there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure and death.
“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” stated Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.”
The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are only available by prescription and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks and should be performed only under medical supervision.
The FDA has noted an increase in “chelation therapy” products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths.
Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy.
“FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness,” noted Dara Corrigan, associate commissioner for Regulatory Affairs.
The companies must take prompt action to correct the legal violations cited in the warnings letters or face possible legal action, including seizure and injunction.
The FDA issued warning letters to the following companies:
- World Health Products: Detoxamin oral, Detoxamin suppositories, and the metal detector test kit;
- Hormonal Health and World Health Products: Kelatox suppositories, and the MetalDetector instant toxic metals test;
- Evenbetternow: Kids Chelat Heavy Metal Chelator, Bio-Chelat heavy metal chelator, Behavior Balance DMG liquid, AlkaLife alkaline drops, NutriBiotic grapefruit seed extract, Natur-Leaf, Kids Clear detoxifying clay baths, EBN detoxifying bentonite clay, and the heavy metal screen test;
- Maxam Nutraceutics/Maxam Labs: PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell, Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion, NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and the heavy metal screening test;
- Cardio Renew: CardioRenew and CardioRestore;
- Artery Health Institute: Advanced Formula EDTA oral chelation;
- Longevity Plus: Beyond chelation improved, EndoKinase, Viral Defense, Wobenzym-N; and
- Dr. Rhonda Henry: Cardio Chelate (H-870)
Boogies be gone
NEW YORK Little Busy Bodies has brought to the market Achooz, a saline nose wipe aimed at adults, following its success with its for-kids version Boogie Wipes.
The saline solution is ideal for dissolving dried mucus, the company noted. Pictured here on a clip-strip, Little Busy Bodies’ pathway to success may mirror that of Airborne, as the line of kids and adult nasal wipes was developed by two moms.
Cub Foods addresses gluten allergies with diet management program
STILLWATER, Minn. Supervalu’s Cub Foods is looking to help customers with gluten sensitivity with the launch of a new, informative diet management program at its stores located in Minnesota, Illinois and Wisconsin.
Developed by Supervalu’s health-and-wellness team and dietitians, the program will roll out in phases over the next three months. The program will present in-store signage about gluten-free foods in Cub Foods stores — as well as in Supervalu’s family of other stores — and also will feature gluten-free shopping lists and guides. In addition to recipes, more extensive gluten-free shopping lists and snack and meal solutions will be available on the stores’ websites.
The new program builds on Supervalu’s Nutrition iQ program, an in-store nutrition ratings system to help customers identify healthy food choices.
“For people suffering from gluten intolerance, eating foods with gluten causes inflammation and damage to the lining of the small intestine, which can result in nutrients passing through the body without being absorbed. This may contribute to other health concerns, including malnutrition, some types of cancers and a variety of autoimmune diseases,” said Anthony Provenzano, Supervalu pharmacy director of clinical programs. “As a whole, the U.S. population is seeing an uptick in gluten intolerance, and there are many more people who have it — but don’t know it. This program is designed to help people manage a gluten-free diet and hopefully encourage others to seek advice from a healthcare professional about a possible sensitivity to gluten.”