FDA warns seller of chelation product

The U.S. Food and Drug Administration (FDA) issued a warning letter to the producer of a product that is sometimes used by people hoping to eliminate heavy metals from children’s bodies (e.g., chelate mercury from children with autism). In a letter addressed to Boyd D. Haley of CTI Science Inc., Teresa C. Thompson of the Cincinnati District Office of the FDA cited a host of problems in the classification and marketing of the product, OSR#1. Among these problems are the following:

• The product is marketed as a dietary supplement but it does not fit that definition;
• The marketing claims indicate that the product is actually a drug;
• The product is what the FDA considers a “new” drug, “because it is not generally recognized as safe and effective for use under the conditions prescribed recommended or suggested in its labeling”;
• Descriptions of the product indicate that it is to be used for “diagnosis, cure, mitigation, treatment, or prevention of disease,” actions that require treatment by medical practitioners, not lay individuals; and
• The product has side effects identified by the company’s own research.

The letter directs the company to “take prompt action to correct the violations” and requires actions within 15 days of receipt of the letter.

The entire letter is available on the FDA website. There are are also stories in the popular press about the letter and other scientists reactions to the use of the substance, OS are number one, for this purpose; see, for example, Trine Tsouderos’ “FDA warns maker of product used as alternative autism treatment: OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious potential side effects, FDA warns” in the Chicago (IL, US) Tribune.

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