However, by law, the FDA does not approve dietary supplements or their labeling, although certain types of claims that are sometimes used in the labeling of dietary supplements require pre-market review and authorization (for example, the dietary supplement industry is regulated by the Food and Drug Administration (FDA), primarily under the provisions of the DSHEA. Dietary supplements cannot claim to treat, prevent, diagnose, mitigate or cure a specific disease (disease claims). However, unlike foods, which can be eaten for pleasure or hunger regardless of their nutritional value, dietary supplements are taken primarily for their supposed therapeutic benefits. Dietary supplements can be considered mislabeled if they are marketed in a way that characterizes them as drugs, without having undergone the clinical trials to which new drugs are submitted.
Technically, the FDA could inspect all foods under a microscope and prohibit the sale of all items containing any noticeable trace of mold, insect fragments, rodent hair and similar products, effectively prohibiting the sale of all foods. Role of the pharmacist In today's environment, pharmacists are the last line of defense for the consumer when it comes to dietary supplements. When taking dietary supplements, be aware of the possibility of an adverse reaction or side effect (also known as an adverse event). In general, even if a product is labeled as a dietary supplement, a product intended to treat, prevent, cure, or alleviate the symptoms of a disease is a drug and is subject to all applicable drug requirements.
A coalition comprised of health food stores, supplement users, the supplement industry, lobbyists and sympathetic members of Congress created a new class of products and, at the same time, declared that this new class would not be subject to the FDA's mission. While supplements are not allowed to be sold on the grounds that they prevent or treat diseases by modifying language, these companies can easily make claims such as “boosting the immune system” or “maintaining a healthy immune system”. Consumers are attracted to dietary supplements because of their easy access, their cultural and historical uses, their low cost, their appeal as natural cures and their presumption of safety and efficacy; by the desire to fend for themselves in matters related to their own health; or because traditional medicine deprives them of their rights. The primary mechanism for monitoring the safety of supplements is a voluntary notification system established by the FDA's Center for Food Safety and Applied Nutrition, called the Center for Food Safety and Applied Nutrition (CAERS) EA Notification System.
Several deficiencies and potentially misleading practices in the labeling of supplements have been documented in the literature. While states have passed some laws to achieve tighter control of ephedrine, state legislation may not be a viable mechanism for strengthening supplement regulation.
