The FDA suggests you should talk to your healthcare provider before using any food additive. In the U.S., supplement safety is regulated by the U.S. Food and Drug Administration (FDA), but legal limitations have prevented FDA from effectively regulating supplements (e.g. This has increased risks to public health, which has led to many calls for reform. Unlike either foods or drugs, supplements are not required to be registered or approved by FDA before manufacturing or selling.
Additionally, manufacturers are not required to submit proof of product safety to FDA before marketing dietary supplements, except when supplements contain a novel food ingredient (a dietary ingredient not sold in this country before Oct. 15, 1994) that has not been presented in the food supply as a food-use article in a form that has not been chemically altered. Further, there is no requirement for manufacturers to provide evidence of product safety to Food and Drug Administration prior to marketing a dietary supplement, unless the supplement contains a new dietary ingredient (a dietary ingredient that was not marketed in this country before October 15, 1994) that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered. If a dietary supplement includes claims about an effect on body structure or function, claims about overall health, or claims about benefits related to classic nutritional deficiencies, the food supplement also bears a disclaimer that indicates the claims are untested by FDA, or claims about benefits related to classic nutritional deficiencies), the FDA has not evaluated these claims, and that a claim about the effects on body composition, the claims are intended to diagnose, cure, cure, or prevents disease. CFSAN has also issued consumer alerts regarding unsafe products, such as an alert that the Agency issued regarding dietary supplements that contain cava, a botanical ingredient; it continues to communicate with the dietary supplement industry regarding practices permitted by the Act.
In sum, our review found that a substantial number of weight loss products in the marketplace that contain Fucoxanthin could be either misbranded or mislabeled, and FDA could require increased dietary supplement surveillance in order to protect consumers taking such products. We also discussed weight loss and bodybuilding supplements, as well as a variety of botanical supplements, that were associated with more serious adverse effects. Our findings also underscore ongoing concerns for the public health caused by some supplements. The public health choice with most benefits, except for those noted above, is eating a nutritious diet that meets all macro- and micronutrient needs.
If you have specific health conditions and are taking products like these, you could put yourself at risk. Many supplements contain ingredients with powerful biological effects, and these products may not be safe for everyone. Some supplements interact with one another and with prescription medications in ways that can adversely affect health. Consumption of food and herbal supplements is common among patients hospitalized, and interactions are frequently missed by physicians.
Natural and Dietary Supplements Regulations
Consequences are increasing as consumption of these misbranded and sometimes adulterated supplements increases. Numerous reports detail dangerous substances such as amphetamine analogs and other stimulants–included in certain products labelled as health supplements and sold to U.S. consumers on claims like reducing weight, improving athletic performance, or improving sexual function. The most prevalent disclaimer in the medical market is one displayed on packaging and advertising for most vitamins and nutritional supplements. Between June 1997 and March 1999, the FDA received 140 reports of adverse events from users of Ephedra products. Ephedra products are regulated as food additives under the 1994 Nutritional Supplement Health and Education Act. Food additives are generally considered to be safe, and are regulated as foods, not drugs.
Because dietary products are not subjected to the same large number of clinical trials that are conducted for prescription drugs, they are generally untested for their general safety or effectiveness profiles. The 1994 Dietary Supplement Health and Education Act (DSHEA) sought to prevent manufacturers from making unsubstantiated claims, the dissemination of unsafe or fraudulent molecular entities, to the general public. Under DSHEA, supplement manufacturers are not required to prove safety or efficacy; Rather, the DSHEA deliberately minimizes the supervision by U.S. Food and Drug Administration, and emphasizes the industrys value to the U.S. economy. The DSHEA does require manufacturers to verify safety and labeling of their products prior to marketing. Under the Dietary Supplement Health and Education Act, the burden of proof to prove a dietary supplement is unsafe falls to FDA, rather than on manufacturers. Additionally, FDA is not in charge of quality assurance, meaning that discrepancies between a products actual ingredients or potency and its labels may exist.
Under the Dietary Supplement Health and Education Act (DSHEA) the 1994 act that established the current regulatory framework for dietary supplements the FDA does not typically perform premarket reviews of dietary supplements, nor is it required to submit essential information to the agency regarding its products, including names or ingredients, prior to marketing. This leaves the agency without clear visibility into what is on the market at any given moment. Quality issues within the supply chain also present a risk for safety. FDA inspections of dietary supplement manufacturing facilities have consistently revealed violations of federal standards for quality and accurate labeling. Unlike drugs or devices, the FDA does not regulate dietary supplements for effectiveness. Under current law, the FDA may act only when it finds that supplement manufacturers make unlawful claims about their products or have broken the rules governing product labeling.
The NIH has made recommendations regarding prescription drugs and supplements to help lose weight, particularly in individuals with a BMI>/=30, or for patients with BMIs equal to or greater than 25 and 29, or with waist sizes at higher risk, who present with two or more risk factors . There are reported cases of endometriosis in women who use isoflavone supplements and, given clear evidence for estrogenicity, the possibility exists that there are increased risks for estrogen-sensitive cancers among consumers of these products. Your healthcare provider can discuss with you if a specific product is safe for you to take, and whether that product is right for your needs.