The Federal Food, Drug and Cosmetic Act (FFDCA) encompasses a set of laws that provides the U.S. Food and Drug Administration (FDA) with the authority to act as an overseer of the safety of cosmetics, drugs and food. Originally passed in 1938, this act is regularly updated.

In mid-October 2010, the FDA, acting in accordance with the FFDCA, issued warnings the following eight companies regarding their marketing of over-the-counter (OTC) chelation products:

• Artery Heart Institute, LLC
• Cardio Renew, Inc
• Evenbetternow, LLC
• Hormonal Health, LLC
• Longevity Plus
• Maxam Nutraceutics/Maxam Laboratories
• World Health Products, LLC
• Dr. Rhonda Henry

While products manufactured by these companies had not yet been approved by the FDA, the companies claimed that their products could treat a range of diseases, including:

• Alzheimer???s disease
• Parkinson???s disease
• cardiovascular disease
• autism spectrum disorder
• macular degeneration

Making such claims without FDA approval is in direct violation of the FFDCA.

It is unfortunate, in that the marketing material in question targets those that suffer or have a family member that suffers from a disease where an efficacious therapy does not exist (such as Alzheimer???s disease where patients may be unresponsive to the latest drugs available).

What further complicates matters is that patients believe the unsubstantiated claims in the manufacturers marketing materials. This causes patients to delay seeking effective medical care, because they are relying on claims for the OTC products that are much easier (and cheaper) to get! In addition, it is often unknown what sort of adverse effects may occur as a result from taking these products.

For more information, see the FDA website for a complete listing of products from these companies.