The U.S. Food and Drug Administration (“FDA”) regulates dietary supplements as food, not as drugs.  In general, dietary supplements are taken orally and contain a dietary ingredient such as a vitamin, mineral, amino acid, herb, botanical, or other substance used to supplement the diet.  The FDA warns consumers that dietary supplements may be harmful, may contain hidden or deceptively-labeled ingredients, and are not intended to treat, diagnose, cure, or alleviate the effects of any disease.  In fact, the FDA has recalled numerous products containing potentially harmful ingredients.

Although federal law requires that dietary supplements be labeled as such (either as a “dietary supplement” or with “[ingredient description] supplement”) and that products be labeled correctly and advertised fairly, the FDA does not pre-approve dietary supplements or require that they be proven safe before they are marketed and sold.  Nor does the Federal Trade Commission (“FTC”) pre-approve any advertising related to dietary supplements.  As a result, there is no requirement that manufacturers/sellers prove that their products are safe or that all advertising claims are accurate before they market or sell the products.  Instead, it is the company’s responsibility to ensure product safety and truthful advertising, and the FDA and FTC only get involved after such products have already entered the market—with the FDA regulating safety issues and the FTC regulating advertising issues.

To bolster its ability to regulate such safety issues, the FDA requires that sellers of dietary supplements report any serious adverse events reported by consumers or health care professionals within 15 days of receipt and that the FDA monitor and investigate those reports.  Likewise, the FDA monitors and investigates any adverse event voluntarily reported by consumers or health care professionals and encourages such voluntary reports to be made directly to the FDA as soon as possible.

As always, manufacturers/sellers of dietary supplements should make sure that their products are safe, properly labeled, and advertised truthfully.  In addition, companies should make sure to report any serious adverse events to the FDA within the required time frame.

Moonlight Slumber, LLC, an Illinois company that advertised its baby mattresses as “organic,” has agreed to settle FTC charges that it misrepresented or could not support these and other claims to consumers.

The FTC’s administrative complaint alleged that in marketing and advertising its baby mattresses, Moonlight Slumber misrepresented a range of claims on its website and in its packaging.  For example, the complaint charged the company represented that two of its lines of its mattresses are “organic.”  According to the FTC, however, very little of the mattresses were made from organic material.

The proposed settlement order prohibits Moonlight Slumber from making misleading misleading representations regarding whether any mattress, blanket, pillow, pad, foam-containing product, or sleep-related product is “organic,” “natural,” or “plant-based,” among other things.  The order also requires the company to have competent and reliable evidence, including scientific evidence when appropriate, to support any claims in these areas.

This is the FTC’s first case challenging “organic” product claims, and could be a signal that more are to come.  Companies using this language to market or promote their products should take note and ensure that they can support any such claims.

The U.S. Food and Drug Administration (“FDA”) requests that consumers report any issues they experience with FDA-regulated products so that the FDA can further protect the public health. But it isn’t always clear which products the FDA regulates and which products it doesn’t. Generally, the FDA regulates the following product categories: certain foods, drugs, biologics, medical devices, electronic products that give off radiation, cosmetics, veterinary products, and tobacco products. Within each category is a number of products subject to the FDA’s regulatory authority. A more detailed, though non-exhaustive, list of the products the FDA regulates can be found on the FDA’s website. According to the FDA, these products account for about one-fifth of annual spending by U.S. consumers.

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The FDA is committed to ensuring that the products it regulates are safe, effective, and correctly labeled. But the FDA does not pre-approve for safety and effectiveness all of the products it regulates before such products can be marketed and sold. For example, the FDA does pre-approve new drugs, biologics, and certain medical devices, but does not pre-approve cosmetics (with the exception of certain color additives) or dietary supplements (though a notification is required for those containing a new dietary ingredient). However, the FDA requires that cosmetics, dietary supplements, and other products be safe for their intended use and be properly labeled/advertised. Accordingly, for such products that the FDA does not pre-approve, the FDA still has regulatory authority to take action when a safety issue arises. With respect to tobacco products, the FDA does not regulate safety in the same way as with other products, as the FDA views tobacco use as a major threat to public health. Notably, last year, the FDA finalized a new rule extending its regulatory authority to all tobacco products, including e-cigarettes, and restricting youth access to such products.

As always, companies should ensure that they products they market and sell are safe for their intended use, are properly labeled, and are fairly advertised. One form of advertising that has caught the FDA’s attention is the phrase “FDA Approved.” The FDA’s recently-updated explanation on what it does and doesn’t approve (and under what circumstances) can be found on the FDA’s website. The FDA’s website also contains detailed information for companies that market and sell FDA-regulated products, including the ability to search for guidance documents that describe the FDA’s interpretation on various regulatory issues and the ability to submit questions regarding the FDA’s policies, regulations, and regulatory process.