In general, the FDA does not require approval of dietary supplements before they reach the consumer. Unlike drugs, dietary supplements are regulated by the FDA as foods, not as drugs. However, many dietary supplements contain ingredients that can conflict with a medication or medical condition. Additionally, some products falsely marketed as dietary supplements can put consumers at risk.
For these reasons, it is important to consult with a healthcare professional before using any dietary supplement. In 1973, the FDA appointed an expert advisory panel to explore over-the-counter vitamins as part of the FDA's comprehensive review of over-the-counter medications. Before 1994, dietary supplements were subject to the same regulatory requirements as FDA foods. On November 11, 1989, the FDA warned consumers to stop taking tryptophan to treat menstrual problems and sleep disorders.
Starting in 1962, the FDA tried to revise the 1941 rules to adopt the Recommended Daily Allowance (RDA) and restrict the amount of each vitamin in any product to 150% of the U. S. UU. Supplements are now often marketed without demonstrating that they work as claimed, causing the FDA or FTC to update them after distribution.
In today's environment, pharmacists are the consumer's last line of defense when it comes to dietary supplements. A coalition of health food stores, supplement users, the supplement industry, lobbyists and members of Congress created a new class of products and declared that this new class would not be subject to the FDA's mission. Although pharmaceutical products must undergo rigorous testing and allocate a large part of their budget to obtain FDA approval and go to market, producing a supplement involves much less investment. In 1991, President George H.
W. Bush enacted the Nutrition Labeling and Education Act (NLEA), which required foods and dietary supplements to carry nutrition labels. This brief review of such a complex subject shows that the FDA has gradually lost authority to regulate dietary supplements containing vitamins in the same way that legitimate over-the-counter drugs and prescription drugs are regulated.