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Industry Regulations & Compliance

While some people think that the supplement industry is not regulated, this is actually not true. Swanson, and all supplement companies, must follow guidelines set forth by various governmental bodies. These help protect consumers by ensuring that claims made by companies are truthful and that the products are safe.

It’s important to note that the term “dietary supplement” was first defined by Congress in the Dietary Supplement Health and Education Act (DSHEA) of 1994. This act specifically reaffirmed the status of dietary supplements as a category of food and created a definition for dietary supplements.

Who Regulates Supplements?

The dietary supplement industry is regulated by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). The FDA has regulatory authority under the Federal Food, Drug and Cosmetic Act. Virtually all facets of supplement manufacturing, labeling and marketing are covered by extensive regulations issued and enforced by the FDA and FTC.

The FTC's Role

The FTC works to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help consumers spot, stop and avoid them. The FTC regulates advertising for dietary supplements and most other products sold to consumers. The FTC’s focus is on making sure that claims made on supplements are truthful and not misleading.

The FDA's Role

The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply and cosmetics. Under DSHEA, a company is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading.

Because dietary supplements are under the “umbrella” of foods, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. The FDA’s efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.

What Happens to Unapproved Drugs?

The FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market. A product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved—and thus illegal—drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in DSHEA.

*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.

The FDA regulates supplement labels and other labeling, such as package inserts and accompanying literature; the FTC regulates dietary supplement advertising.

Swanson's Commitment to Compliance

Swanson Health Products carefully evaluates each and every product to ensure compliance with these regulations. All products and information provided to our customers are reviewed for safety, efficacy and accuracy.

If you have any further questions or would like additional clarification on how we comply with these regulations, please contact us.

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