Muscle Gain Supplements That Are Approved by the FDA

Muscle growth products, ranging from pills to powders and liquids, are a popular form of dietary supplement that many people use in an effort to build muscle mass. Unlike medications, muscle growth products are usually sold as "dietary supplements," a category that has specific applicable regulations, but that does not require the approval of the Food and Drug Administrartion, or FDA.

A man is drinking from a shaker bottle. (Image: Ibrakovic/iStock/Getty Images)

FDA Approval

Manufacturers do not have to receive approval from the Food and Drug Administration when they want to sell or market any dietary supplements, including those that aid in muscle growth. If the manufacturer wants to sell a muscle growth drug, either as prescription medication or for over-the-counter sales, it has to go through the drug approval process. Otherwise, if the manufacturer only wants to sell a dietary supplement, it only has to ensure that the product it sells is safe for human use.

Manufacturer's Role

All manufacturers of dietary supplements must ensure that the muscle growth products they sell are safe under the terms of the Dietary Supplement Health and Education Act, DSHEA, of 1994. This law allows manufacturers to bring products to market without having to go through the FDA approval process. The law also requires that any claims the manufacturers make in advertising or marketing their products must both be supported by evidence, and that they are not false or otherwise misleading.

FDA's Safety Role

The FDA's role in regulating muscle gain products and other dietary supplements is primarily one of investigation and supervision. While manufacturers have to report any known incidents of harmful health effects that consumers experience after using the muscle gain supplement to the FDA, the FDA can only take restrictive actions if it determines that the supplement is unsafe. Unless the FDA investigates a muscle growth supplement and finds it to be unsafe, it will not order a recall or take other such steps.


When the FDA determines that a dietary supplement poses a health risk to people, it can issue a recall or take other actions to limit the product's use or sale. The FDA posts these recalls on its website,, and issues press releases whenever it finds that a dietary supplement is unhealthy or unsafe. The FDA also issues consumer warnings that a product might be unsafe, has an untested ingredient or similar conditions. In these instances, it is not uncommon for a manufacturer to issue a voluntary recall, even though the FDA has not compelled it or has not determined the product to be unsafe.

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