With over 90,000 different supplements on the market, it can be confusing to figure out which ones are safe and which ones are not. Under federal law, supplements must contain ingredients like vitamins, minerals, and herbs, but they cannot contain any medications, and they may be sold over-the-counter. In the European Union, food supplements are regulated like foods, with the legislation focused on vitamins and minerals used as ingredients of food supplements.
In Australia, most dietary supplements are regulated in a complementary medicines category that includes vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods for specific purposes and are regulated by food authorities. The food additives industry is regulated under the Food and Drug Administration, mostly in accordance with provisions in DSHEA. Under DSHEA, supplement manufacturers are not required to demonstrate safety or effectiveness; Rather, DSHEA deliberately minimizes the supervision by the U.S. Food and Drug Administration, focusing instead on the industrys value to the U.S. economy. It is important to note that the FDA does not have authority to review food additive products for safety and effectiveness prior to marketing.
FDA regulates dietary supplements through a different set of regulations from the ones that cover conventional foods and drugs. The Food and Drug Administration regulates dietary supplements pursuant to the Dietary Supplement Health and Education Act of 1994, but because this obsolete legislation has major gaps, the Agency is not effective or efficient at protecting the publics health. The FDA regulates the quality, safety, and labeling of dietary supplements, while the Federal Trade Commission oversees advertising and marketing; however, there are significant enforcement challenges, and the governments best surveillance has yet to be achieved. Some consumer groups, along with the FDA, argue that the FDA should be given greater statutory power to review supplements before selling them to consumers.
The survey also found that roughly half of adults overestimate FDA regulations on supplements, incorrectly thinking the agency reviews or tests such products before they hit the market. Two critical issues to be addressed are FDAs failure to be aware of supplements that are available in the marketplace, and its failure to order the recall of supplements containing pharmaceutical ingredients. In cases in which supplements are contaminated with drug ingredients, gaps in the law leave the agencys recall powers murky. The FDA has also said dietary supplements that are contaminated with drugs are considered drugs under the law, and FDA does not have mandatory recall authority for them.
While the FDA may order the recall of dietary supplements, mandatory listing requirements for products do not apply to drugs, which have to be recalled by manufacturers on their own initiative. The U.S. alleges in the civil complaint that Michael Travalino sold several preparations through his storefront and his website as a guaranteed cure and remedy, even after receiving a joint notice from FDA and the Federal Trade Commission informing him that his distribution of products was a violation of FTC law and Federal Trade Commission law. The defendants refused, in writing, to stop their violative conduct even after receiving a warning letter from the Food & Drug Administration and FTC advising that distribution of the miracle mineral solution violated the Federal Food, Drug, and Cosmetic Act. A study published in The Journal of the American Medical Association found that over 700 diet supplements sold from 2007 through 2016 contained drug ingredients–such as sildenafil (Viagra) and anabolic steroids–that were subject to FDA warnings.
Dietary supplements may include generic health claims, nutrient-content claims, or structural-function claims. Certain scientific evidence only needs to be submitted to FDA for health claims, establishing a direct link between use of the supplement and reduced risk for illness. These only apply to supplements that contain vitamins and/or minerals, in cases in which those products are regulated as foods, and address supplement composition, including safety, purity, and bioavailability. Dietary supplements are included under the health functional foods (HFF) category in South Korea, regulated by the Ministry of Food and Drug Safety (MFDS) according to the HFF Act, in order to promote safety (94). In certain cases, excess consumption of vitamins and minerals can cause harm or cause undesirable side effects; thus, a maximum amount is required to assure safe supplement usage in foods.
Eating foods high in vitamin C is important for overall health, particularly if you are at risk of high blood pressure. Population-based studies (which involve looking at a large group of people over time) have shown that those who eat foods high in antioxidants, including vitamin C, have a lower risk of high blood pressure compared to those with a poor diet. Many results from population-based studies indicate that eating foods rich in vitamin C may be associated with lower rates of cancer, including skin cancer, cervical dysplasia (changes in the cervix that can be either cancerous or precancerous, picked up through Pap tests), and, potentially, breast cancer. These foods also contain a variety of useful nutrients and antioxidants, not just vitamin C, so it is not possible to definitively say that vitamin C protects against cancer.
If your vitamin C levels are low, and you are having difficulty getting enough from the foods you are eating, talk to your doctor about taking a supplement. Another concern is that an over-the-counter supplement might be made from analogs, or experimental variations on existing medications, that have not been tested for safety. In 2019, Walmart agreed to take down one Rhino supplement from its website after the FDA labeled it as containing hidden drugs, a fact highlighted by a local TV news station.