June 20, 2012
The following post appears courtesy of the Consumer Protection Branch of the Civil Division The dietary supplement industry has grown exponentially in recent decades, expanding from a niche health market into a major industry offering purported solutions for all types of ailments. In 1994, Congress struck a balance between the dietary supplement industry and the public interest by enacting a law that generally treated dietary supplements as food rather than medicine. That means, for example, dietary supplements are generally not required to go through pre-market approval like pharmaceuticals. In 2007, the Food and Drug Administration (FDA) recognized that stronger regulations for the manufacturing of dietary supplements were needed. Important new requirements have been introduced, in an effort to ensure that dietary supplements contain what they claim to contain. In the last few years, the Consumer Protection Branch of the Civil Division, the FDA, and the Federal Trade Commission have collaborated in a number of actions designed to protect consumers. When its inspections reveal serious deficiencies in a dietary supplement firm’s labeling, manufacturing, or advertising, the FDA typically sends the firm a warning letter giving the firm a certain amount of time to rectify the violations, and may work with the firm to recall products with potential risks. You can find out about these actions and protect yourself by signing up for FDA recall alerts and by checking the FDA and FTC websites for warning letters issued to firms whose dietary supplements you may have purchased. If the firm does not remedy the violations, the matter may be referred to the Justice Department for civil or criminal prosecution. In one recent case, the Consumer Protection Branch filed a civil suit against a Paterson, NJ-based supplement maker that had a serious rodent infestation, manufacturing problems that resulted in allergen cross-contamination, and various labeling errors. One of the firm’s products—which had been labeled to be dairy-free but in fact contained milk—even caused a life-threatening anaphylactic reaction in a consumer with a severe milk allergy. Flouting a court-ordered shut down, the manufacturers simply opened up shop in a new location. Ultimately, the Justice Department secured a criminal conviction and the firm was ordered to pay $1 million in fines. Perhaps more significantly, the three principals of the firm were given lengthy prison terms: 40 months for the president and 34 months for the production and quality assurance managers. Violations in the dietary supplement industry will not be tolerated. Consumers turn to these products for their health and sense of well-being. Consumers rely on the labels of dietary supplements to tell them about the effectiveness of the supplements and the allergens in the product. Consumers should be able to trust that the companies that produce dietary supplements make sure their products are free from harmful impurities and manufactured under sanitary conditions. For more information, visit the FDA website and sign up for recall alerts.
Updated September 15, 2014