Dietary Supplement Companies Don’t Always Follow Labeling Guide

Ever since the Food and Drug Administration (FDA) issued the 2005 Dietary Supplement Labeling Guide, an underlying issue with the language of the guide has been waiting to bubble to the surface.

According to legal experts, the FDA’s labeling guide for dietary supplement products contradicts itself on just how a health product is or is not compliant in terms of federal standards for homeopathic remedies and other health products’ labeling standards.

In 1998, the agency stated that dietary supplement products needed to be identified with a “Supplement Facts” panel, located on the back of said product.

On the front of the dietary supplement, the FDA mandated that “A statement of identity will appear on the front panel of the product label. The statement must use the terms ‘dietary supplement’ or a term identifying the contents of the product, such as ‘Vitamin C supplement’ or ‘Herbal supplement.’”

However, as previously stated, this seems to be contradicted, or at the very least complicated, in another section of the same FDA guidelines document.

A Question and Answer section was also featured in the 2005 Dietary Supplement Labeling guidelines, where the question was brought up as to whether or not the term “dietary supplement” on its own was considered a statement of identity by the agency.

The FDA’s published answer states, “No. This term by itself is not appropriately descriptive to be a statement of identity.”

But the question still remains if putting “dietary supplement” on the front and Supplement Facts on the label enough to satisfy federal regulations?

According to the guidelines, a homeopathic company would be in legal trouble for not providing additional terms to quality as a statement of identity.

However, if one were to read the actual FDA regulation separate from the 2005 Dietary Supplement Labeling Guide, it would seem that the statement with the addition of the back Supplement Facts label is sufficient and satisfy the intent of the law, at least according to some legal experts.

Potential Homeopathy and Dietary Supplement Litigation

Because of the apparent contradiction in the FDA regulations and guidelines for the labeling of dietary supplements, it could serve as the basis for possible dietary supplement lawsuits or class action lawsuits against homeopathic product companies.

If one considers the recent Supreme Court ruling on the Affordable Care Act, which was based on the exact meaning of “established by the state,” then the language used in the FDA’s 2005 Dietary Supplement Labeling Guide could provide a large number of consumers with legal recourse against companies for not properly labeling their dietary supplement of homeopathic products.

For those businesses that sell these products in the state of California, this could be especially damaging, because according to California law, a company is considered to be in violation of California consumer protection laws if they first violate laws stemming from the Food, Drug & Cosmetics Act.

The state’s consumer protection laws not only have a private right to enforcement but can also lead to a company being sued by individual plaintiffs or a group of consumers.

Although many attorneys and those within the agency agree that this contradiction in language should be fixed, the wording of these FDA dietary supplement guidelines has remained the same.

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