“Collagen supplements in the United States are largely unregulated by the Food and Drug Administration due to the Dietary Supplement Health and Education Act of 1994.”

This Act may be cited as the 'Dietary Supplement Health and Education Act of 1994'. The Act defines a 'dietary supplement' as a product (other than tobacco) intended to supplement the diet that bears or contains one or more dietary ingredients, including vitamins, minerals, herbs or other botanicals, amino acids, or dietary substances for use by man to supplement the diet. It also includes provisions for 'new dietary ingredients' that were not marketed in the United States before October 15, 1994, requiring notification to the Secretary.

No U.S. Food and Drug Administration (FDA) approval is required to produce and market a dietary supplement. For manufacturers, there is no need to demonstrate safety or efficacy prior to marketing.

In the United States, the regulation of dietary supplements, including collagen, falls under the Dietary Supplement Health and Education Act (DSHEA) of 1994. This act classifies supplements as food products rather than drugs. As a result, the FDA does not require dietary supplements to be proven safe or effective before they can be sold to consumers. This lack of pre-market approval means consumers need to exercise caution and conduct thorough research before choosing a product.

Under DSHEA dietary supplements are regulated by the Food and Drug Administration (FDA) as a category of food, not as drugs. This means that dietary supplements do not need FDA approval before they are marketed. DSHEA aims to ensure that consumers have access to safe and properly labeled dietary supplements while providing the FDA with the authority to take action against unsafe or misbranded products after they reach the market.

Under the FDA, supplements are regulated as foods rather than drugs. Dietary supplements are thus exempt from federal pre-market review. Instead, manufacturers are responsible for determining product safety and efficacy.

The Food and Drug Administration regulates dietary supplement quality, safety, and labeling, and the Federal Trade Commission monitors advertisements and marketing; still, vast enforcement challenges remain, and optimal governmental oversight has not been achieved. DSHEA places the burden of proving that a supplement is unsafe, or marketed without adequate notification or proof of safety, on the FDA.

According to the Dietary Supplement Health and Education Act (DSHEA), all dietary supplements making structure/function claims must include a disclaimer stating: “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.” The FDA has rarely enforced the existing requirement for this disclaimer to appear on every panel where structure/function claims appear, and intends to exercise enforcement discretion.

Fact: Botanicals, vitamins, minerals and other “dietary supplements” (as defined in U.S. law and explained by FDA) are subject to comprehensive FDA oversight and associated regulations. For example, FDA rules govern how products are manufactured and labeled. FDA has premarket safety authority over supplements containing “NDIs.” NDIs are generally subject to premarket review by FDA to demonstrate that the NDI-containing supplement “will reasonably be expected to be safe.” FDA reviews the identity and safety of these new dietary ingredients.

DSHEA is the acronym for the Dietary Supplement Health and Education Act of 1994. The law provides FDA with appropriate regulatory authority and ample enforcement tools to protect consumers while still allowing them the desired access to a wide variety of affordable, high quality, safe and beneficial dietary supplement products. DSHEA provided FDA with additional enforcement authority, including the ability to remove from the market products the agency deems unsafe through: 1) an “imminent hazard” clause which permits FDA to immediately remove a product it considers to present an immediate safety concern and 2) a “significant or unreasonable risk” clause that allows removal of a product considered to pose an unacceptable risk of illness or injury.

As with all supplements, collagen is not regulated by the Food and Drug Administration (FDA). So, the purity of their active ingredient is not standardized. Collagen supplements do not have to be proven effective or safe. The studies that have been done on the safety and effectiveness of collagen supplements are limited and most were funded by the supplement industry, creating concerns of bias.

DSHEA codified Congressional intent that dietary supplements should be uniquely regulated, not the same as either foods or drugs, but within the framework of food law. The regulatory approach provided by DSHEA essentially limits FDA to only taking retroactive action after unsafe products are sold. Moreover, manufacturers may label their supplements with a variety of health support benefits that do not amount to drug claims, as long as the label includes a statement that such claims had not been evaluated by FDA.

On October 25, 1994, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA), passed unanimously by both houses of Congress. This law radically changed the regulatory landscape for the sale and labeling of dietary supplements, restricting the Food and Drug Administration's (FDA's) authority in certain ways, and encouraging the sale of dietary supplements, including vitamins, minerals, herbs, botanicals, and amino acids.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines dietary supplements and places primary responsibility for safety on manufacturers, with FDA retaining authority for post-market enforcement, labeling, and adulteration issues. Collagen supplements, as dietary supplements, fall under this framework without pre-market approval.