Like drugs, supplements are regulated, although the process is somewhat different. Drugs go through a rigorous approval process. A drug manufacturer must provide the Food and Drug Administration (FDA) with extensive data showing its product is safe and effective before it can be marketed and sold to the public.
Since dietary supplements aren't considered drugs, they can be marketed and sold without going through the same approval process. However, this doesn't mean supplements are not regulated. There are certain regulations that supplement manufacturers must follow. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). The act was an attempt to strike a balance between the manufacture and sale of dietary supplements — classified as a special type of food — and providing some oversight and regulation to a group of products that potentially could be hazardous to public health.
Essentially, the DSHEA:
- Prohibits the use of supplements that are toxic or dangerous
- Allows the secretary of the Department of Health and Human Services to ban supplement ingredients considered hazardous
- Gives the FDA authority to implement a set of protocols, called Current Good Manufacturing Practices (CGMPs), that manufacturers must follow
To comply with the law, dietary supplement manufacturers must:
- Register their facilities with the FDA and allow FDA inspectors access to their facilities for random inspections of the manufacturers' compliance with CGMPs
- Make sure all claims and information on the product label and other labeling are truthful and not misleading
- Follow CGMPs design to ensure supplement quality, including the identity, purity, strength and composition of the ingredients
- Document and submit to the FDA all reports of serious adverse events associated with use of the supplement in the United States
Manufacturers don't have to:
- Prove to the FDA that their products are safe and effective before producing or selling them — unless they contain an ingredient that's considered new, meaning it wasn't marketed before 1994. In this case, the FDA requires that the manufacturer provide specific safety information about the new ingredient.
It's important to note that according to Current Good Manufacturing Practices regulations, all supplements sold in the U.S. are mandated to have in the bottle exactly what is stated on the label. While the product offers no guarantees, you can feel more comfortable knowing that what you read on the outside is what you'll find on the inside. Granted, there are still some bad actors out there, but finding good-quality products is becoming easier.
March 16, 2019
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