Are supplements regulated by the FDA?

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products.

Why supplements should not be regulated?

Why doesn’t the Food and Drug Administration (FDA) regulate the safety and sale of nutritional supplements? Because they’re classified as food products, not medicines, so they aren’t regulated by the strict standards governing the sale of prescription and over-the-counter drugs.

Do supplements need FDA approval?

Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell.

Why can’t the FDA regulate herbal drugs?

Because the manufacturers do not have the burden of proving their products are unadulterated (and thus safe for consumption), the FDA cannot require any kind of premarket approval for herbal products.

What products need FDA approval?

Products requiring FDA approval prior to being marketed (FDA’s premarket approval requirements):

• Drugs and biologics.
• New ADDITIVES to animal drugs and animal foods.
• Medical devices.
• Human tissues and cells (blood, bone and tissue products)
• Food ingredients and additives.
• Color additives and other additives.

What products aren’t FDA approved?

FDA does not approve cosmetics. Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients, and their labeling, do not require FDA approval before they go on the market.

Should herbal supplements be regulated?

Herbal supplements are unregulated, overhyped, and potentially deadly. By defining herbal supplements and botanicals as dietary supplements, DSHEA exempted them from the more rigorous standards used by the FDA in regulating food, drugs, and medical devices—essentially leaving it up to the industry to regulate itself.

Do I need FDA approval to manufacture herbal products?

However, the FDA doesn’t make this distinction, and as an herbal product manufacturer, it’s important to educate yourself regarding what is legally required of you. A starting point is your local and state board of health, which can often provide guidance to help you begin your research.

What is the FDA’s role in the labeling of dietary supplements?

For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA’s satisfaction that the claim is accurate or truthful before it appears on the product. In general, FDA’s role with a dietary supplement product begins after the product enters the marketplace.

Should herbal supplements be tested before marketing?

Herbal supplements do not need to be tested before marketing, as is required for prescription and over-the-counter drugs. Producers of dietary supplements engage in deceptive marketing and do not adequately label products to inform consumers about their nature and regulation.