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)
H.D. Smith subsidiary launches new website
WOOD DALE, Ill. Smith Medical Partners, a business focused on specialty pharmaceutical distribution and solutions, announced the launch of its new company website.
The H.D. Smith subsidiary said its new site, Smpspecialty.com, features a user-friendly platform that includes audience-specific landing pages, including relevant products and FAQs tailored for unique segments of the healthcare industry.
Additionally, the site also will feature Smith Medical Partners news, reimbursement announcements, recall postings and industry developments, as well as e-newsletters that are tailored for multiple specialty practices, placing Smith Medical Partners customers among the first to receive details on new product launches, special purchasing opportunities and program information.
“Our online visitors will now experience a more comprehensive and vibrant view of Smith Medical Partners,” said Smith Medical Partners VP David DuRoss. “We have taken a strategic approach to providing rich content in an accessible and streamlined layout.”
Foundation for HealthSmart Consumers: New OTC reimbursement rule will be costly
WASHINGTON A panel of healthcare thought leaders has concluded that a recent IRS rule change requiring a written prescription so that over-the-counter medicines can be eligible for reimbursement under flexible spending accounts will demand retail system challenges that are operationally impossible to overcome in the time frame required.
“We see this as a threat to consumer access and choice at a time when we need our citizens to be more engaged in managing their health and the cost of care,” stated Jon Comola, executive director of the Foundation for HealthSmart Consumers. Because of the new rule change, Comola said, “some consumers are likely to seek prescriptions for OTCs or alternative [prescription] drugs in order to comply with the new tax requirement.”
According to Foundation researchers, the resulting costs could reach $2.5 billion annually if office visits and lab tests are incurred by even 10% of the insured population; potential new pharmacy costs could reach $3 billion annually.
“We are concerned about the negative impact on people who are using OTCs to address health issues like smoking cessation, weight control, arthritis and allergies because of the increased tax on higher cost products,” said Jim Parker, fellow for The Foundation. “This may result in increased physician visits and potentially the prescribing of more expensive prescription drugs.”
The number of consumers who take advantage of health spending accounts is not insignificant, the Foundation added. “More than 50 million of the 195 million commercially insured consumers have healthcare accounts and will be directly affected by this new rule,” noted Roy Ramthun, president HSA Consulting.
As of Jan. 1, consumers will no longer be able to pay for most OTC medicines with funds from their flexible spending accounts and other health accounts (including HSAs and HRAs) unless the OTCs are “prescribed.” Retailers already are taking steps to warn shoppers of the new restrictions on purchases of OTC medicines using funds from their healthcare accounts.
This rule change, enacted as part of the Patient Protection and Affordable Care Act, is intended to help fund increases in healthcare spending in other parts of the bill.