Explaining the Regulatory Framework for Dietary Supplements

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Today’s consumers are taking greater responsibility for their own healthcare. A prime example of this growing trend is the increased use of dietary supplements in the United States. While more consumers are learning the benefits of taking dietary supplements to promote overall wellness, the regulation of dietary supplements is still highly misunderstood. It’s a common misconception that the dietary supplements category is not regulated, when in fact it is regulated by multiple government agencies, with manufacturers and retailers also managing responsibility throughout the process.

As dietary supplements are considered a subset of foods under federal law, they are regulated by the U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission (FTC). FDA holds the primary responsibility for regulating the category through the Dietary Supplement Health and Education Act (DSHEA) of 1994, which established a regulatory framework for assuring the safety of the category. FDA has authority to establish regulations regarding dietary supplement manufacturing, regulating health claims, and labeling.

Government Roles and Responsibilities

FDA and the FTC work together in regulating dietary supplement advertising. FDA is primarily responsible for claims on product labeling, while FTC has the primary responsibility for claims in advertising. Just like any other product on the market, advertising for dietary supplements must be truthful, not misleading, and substantiated before the ad runs.

FDA has the authority to:

  • Stop any company from selling a dietary supplement that is deemed to be unsafe, toxic, or unsanitary.
  • Halt the sale of a dietary supplement that makes false or unsubstantiated claims on its labeling or makes a claim that the product can diagnose, treat, cure, or prevent a disease.
  • Take action against dietary supplements that pose "a significant or unreasonable risk of illness or injury."
  • Ensure dietary supplement companies establish specifications for identity, purity, quality, strength, and composition of dietary supplements.
  • Require companies that manufacture/ process, pack, or hold a dietary supplement (or a component of a dietary supplement) to register as a food facility unless they qualify for an exemption.
  • Inspect manufacturing records and complaint files and require companies to keep them for two years.

FTC has the authority to:

  • Enforce laws banning "unfair or deceptive acts or practices" to make sure consumers are truthfully informed.
  • Challenge and stop advertising that is not adequately substantiated.
  • Investigate complaints or questionable trade practices.
  • Negotiate a consent order or proceed through an FTC process that results in a cease and desist order to change or fix promotion practices.
  • Stop false advertisements or other violations of the FTC Act.
  • Seek civil penalties for violations of trade regulation rules or violations of cease and desist orders.

Manufacturer Responsibilities

While the government maintains the formal regulation of the category, dietary supplement manufacturers are responsible for complying with regulations. On June 25, 2007, FDA published a final rule on Current Good Manufacturing Practices (cGMPs) for dietary supplements, which established standards that manufacturers must follow to ensure quality throughout the manufacturing, packaging, labeling, and storing of their products.

While FDA enforces cGMPs, FDA does not approve manufacturers’ individual dietary supplements before they can be sold. Premarket submission for safety is required in the case of a new dietary ingredient. According to the FDA’s DSHEA, cGMP, and FTC requirements, manufacturers and distributors are required to:

  • Maintain evidence that their products are safe, and that the product’s claims are truthful and not misleading. FDA’s published guidance establishes the amount and nature of the substantiation manufacturers should have.
  • Comply with FTC Dietary Supplement Advertising Guidelines.
  • Notify the FDA of structure/function claims no later than 30 days after the first marketing of the dietary supplement product and have substantiation on file.
  • Maintain responsibility for quality assurance controls even if third party manufacturers or distributors are used.
  • Notify the FDA of a new dietary ingredient (not marketed in the U.S. before October 15, 1994) at least 75 days prior to marketing. The notification must include information regarding the safety of the dietary supplement.
  • Register domestic and foreign facilities with FDA that manufacture, process, pack, or hold food (or dietary supplements/ingredients) for human or animal consumption in the United States.
  • Record, investigate, and forward to FDA any direct reports they receive of serious adverse events associated with the use of their products.
  • Comply with the Code of Federal Regulations (21 CFR 101.36) labeling requirements to ensure that the Supplement Facts label and ingredient list for each product is accurate, that the dietary ingredients are safe, and that the ingredient content matches the amount declared on the label. Information required on dietary supplement labels includes:
    • Statement of identity (e.g., "ginseng")
    • Net quantity of contents (e.g., "60 capsules")
    • Directions for use (e.g., "take one capsule daily")
    • Supplement Facts Panel (lists serving size, amount, and dietary supplement ingredients)
    • Other ingredients not considered dietary ingredients, such as excipients, fillers, artificial colors, artificial sweeteners, flavors, or binders
    • Name and place of business of the manufacturer, packer, or distributor
    • The statement: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." (If claims describing the role of a dietary supplement on a structure or function of the body are made)

The Role of Retailers

FDA also has enforcement over retailers who sell dietary supplements, especially if their advertisements and websites make claims about their products, or if they sell supplements that are not cGMP compliant.

Retailers are required to:

  • Ensure advertisements and communications do not imply that a supplement can treat, cure, or mitigate disease.
  • Ensure that when providing information to consumers about the potential benefits of supplements, that the information is truthful and not misleading, and does not promote a specific brand. If third party literature is provided, it must be in an area that is physically separate from the area in which dietary supplements are displayed.

While retailers have recently implemented quality assurance programs alongside manufacturers, there are still additional steps they can take to instill confidence in consumers. Retailers may also consider implementing internal policies and best practices as an added layer of protection for consumers, for example:

  • Train store associates to avoid providing health advice, discussing disease states, or recommending specific supplements to customers.
  • Train pharmacists and/or in-store dietitians on how to discuss dietary supplements within the DSHEA legal framework.
  • Research a manufacturer’s quality standards and/or third-party certifications.
  • Defer to the claims listed on the product label as the primary source of information. Consumers should look at the structure function claim of the product to understand the intended benefit of the product.
  • Select credible supplement brands that adhere to high quality standards.

Dietary supplements are regulated by the government with support from manufacturers and retailers, despite some misconceptions about the category. Supplements continue to play an increasingly important role in consumers’ health and wellness thanks to the regulatory framework established through DSHEA.

 

Further Reading:

Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry

Dietary Supplement Labeling Guide: Chapter IV. Nutrition Labeling

Standardized Information on Dietary Ingredients (SIDI)