With the growing popularity of alternative medicine, supplements are in greater demand. According to Grand View Research, the supplement industry in the U.S was $123.28 billion in 2019 and was projected to grow at a CAGR of 8.2%. With the number of supplements hitting the market, there are understandable concerns about the quality of testing and regulation. They seem to occupy a category that lies between food and medicine, and this is reflected in the complex issues surrounding the regulation of supplements.
Generally speaking, although supplements with “new ingredients” have to be registered with the FDA, ultimately the manufacturer is responsible for the safety and effectiveness of their products. In most cases, the FDA will only interfere if there seems to be a serious issue with a supplement or if it is illegal. Therefore, consumers should do their own due diligence and research supplements carefully before purchasing.
What Qualifies as a Supplement?
The Dietary Supplement and Health Act (DSHEA) was passed in 1994 to define what a supplement is and to describe the process of supplement regulation. According to the DSHEA, a supplement is something taken orally that contains a “dietary ingredient” intended to supplement the diet.
What is the Relationship Between a Supplement Manufacturer and the FDA?
Before the DSHEA was passed, supplements faced the same type of regulations as foods. However, although supplements were placed in a new category under this law, this didn’t result in a heightened responsibility of the FDA to ensure supplements were safe and effective. This responsibility still lies wholly with the manufacturer of the supplement.
When a supplement contains a “new dietary ingredient,” the manufacturer must supply information to the FDA showing that it is safe and effective. If there is not a new dietary ingredient added, the manufacturer does not have to give over this data. However, supplement manufacturers must register their companies following the Bioterrorism Act and agree to Current Good Manufacturing Practices to ensure the purity and safety of products. Nonetheless, the FDA’s regulations of supplements are rather loose, particularly compared with medicines.
However, the FDA does require supplement manufacturers to list all ingredients and amounts on the label. There must also be nutritional information and certain supplement facts listed. However, the FDA does not influence the amount of ingredients used in supplements and does not keep a record of all manufacturers of certain supplements.
What About Safety?
According to the DSHEA, it is the manufacturer’s sole responsibility to sell a safe and effective product. The FDA can prohibit a product only if it has been proven to be unsafe. Also, it is illegal for a manufacturer to sell a product that purports to be a cure, prevention, or treatment for an illness unless fully approved as such, and supplements are not in this category. Therefore, any supplements containing this language are illegal and supplement manufacturers must publish a disclaimer that their product is not intended to treat or prevent any illness.
If there is suspicion that a supplement may be unsafe, it should be reported to the FDA, which will investigate allegations. It is also important to inform the FDA if the company makes extravagant claims about the supplement’s ability to heal or treat serious conditions.
Let the Buyer Beware
The old saying “let the buyer beware” definitely holds true when it comes to supplements. Although they seem like alternative medicine, the manufacturer not the FDA decides whether they are considered safe and effective, and obviously, a manufacturer has a profit motive. Therefore, those who take supplements should research the ingredients carefully and ask their doctor before purchasing.