In general, the FDA is limited to enforcing the law after marketing because, unlike drugs that must be proven to be safe and effective for their intended use before they are marketed, the law does not require the FDA to approve the safety of dietary supplements before they reach the consumer. In 1990, President George H. W. Bush enacted the Nutrition Labeling and Education Act (NLEA), which required foods and dietary supplements to carry a nutrition label.
Except for people with special medical needs, there is no scientific basis for recommending the routine use of dietary supplements. The most serious problem faced by responsible manufacturers and consumers of supplements is that criminals sell unapproved drugs that are illegally marketed as supplements, but that is not the result of the law, but of illegal activity. The 1973 dietary supplement legislation seemed doomed to failure from the start and destined never to be enforced. Before 1994, dietary supplements were subject to the same regulatory requirements as FDA foods.
The Dietary Supplement Health and Education Act (DSHEA) and subsequent new laws supported by the industry help to make that a reality. However, at the time, the group recognized that, even if the FDA were to become an independent agency, the existing law would prevent further regulation of dietary supplements. Researchers from the Centers for Disease Control and Prevention reported that adverse reactions to dietary supplements cause at least 23,000 Americans to go to emergency rooms each year and thousands to hospital wards. Thanks to the efforts of manufacturers, the 1973 regulations were annulled, returned to the FDA through legal action in 1974, and the FDA reviewed and re-proposed them in 1975.1 During this time, Senator William Proxmire (Democrat from Wisconsin) became the standard bearer of the supplement industry.
If dietary supplements were just a benign waste of money, this would represent nothing more than a waste of money for consumers. However, it is important to understand why these products are not regulated by the FDA in order to protect consumers from potentially dangerous products. In the case of new supplement ingredients, DSHEA requires manufacturers to submit evidence to the FDA that a new ingredient must be safe. The dietary supplement industry is fighting the new FDA guidelines, saying they will be harmful to business.
The lack of regulation in this industry can be concerning for consumers who are looking for safe and effective products. It is important for consumers to do their research before purchasing any dietary supplement product in order to ensure they are getting a quality product from a reputable manufacturer. Consumers should also consult with their healthcare provider before taking any supplement product in order to ensure it is safe for them. It is also important for consumers to be aware of potential side effects or interactions with other medications they may be taking.
The dietary supplement industry is an ever-growing market with many products available on store shelves and online. While there are many reputable manufacturers who produce quality products, there are also some unscrupulous companies who may not adhere to safety standards or provide accurate information about their products. It is up to consumers to do their research and make sure they are purchasing quality products from reputable manufacturers who adhere to safety standards set forth by regulatory agencies such as the FDA. In conclusion, it is important for consumers to understand why dietary supplements are not regulated by the FDA in order to protect themselves from potentially dangerous products.
Consumers should do their research before purchasing any dietary supplement product in order to ensure they are getting a quality product from a reputable manufacturer and should consult with their healthcare provider before taking any supplement product in order to ensure it is safe for them.