The Food and Drug Administration hopes that these will also demonstrate to the public and to the supplement industry that we will act when necessary, and FDA remains committed also to educating consumers and industry on proper labeling and use of food additives. In the U.S., the FDA is responsible for the regulation of supplement safety, however, legal limitations have prevented the FDA from effectively regulating supplements (e.g. This has increased the risk of adverse events for public health, and has led to many calls for reform. Dietary supplements, which include vitamins, minerals, plant and animal extracts, hormones, and amino acids ingested orally, are used extensively in the US, with four out of five adults reporting having taken one. The dietary supplement market has grown exponentially in the past 25 years from a $4 billion industry with 4,000 products in 1994 to one of over $40 billion today, with up to 8,00 products but consumer safety regulations have failed to keep up.
According to 2011-2014 data from the National Health and Nutrition Examination Survey (NHANES), 52% of U.S. adults surveyed (n = 11,024) reported using at least 1 dietary supplement in the previous 30 days, and 31% reported using a multivitamin-mineral supplement. The most commonly cited reasons for supplement use were for general health and wellness and to fill nutrient gaps in the diet. The FDA has received thousands of reports of adverse health events from consumers using dietary supplements that contained Ephedra, including 117 deaths and 2,000 serious cases of cardiac, neurologic, and mental health problems. To prevent patient harm and to promote evidence-based prescription drug use, FDA requires manufacturers to submit data showing a medication is effective and safe before it can promote a medication for a specific indication.
In addition, if the labeling includes a statement that a product affects body structure or function, a statement about general wellness, or a statement about benefits related to classic nutritional deficiencies, a food additive also must bear a disclaimer that indicates the Food and Drug Administration has not evaluated that statement, and the product is not intended to diagnose, treat, cure, or prevent any illness. The concern that a disclaimer might be overridden by other marketing content is especially pertinent for complex health products, including both dietary supplements and prescription drugs promoted for use outside the prescribed indication. The prospect of replacing Food and Drug Administration restrictions on allowable statements about prescription drugs with disclaimers, which are mostly ineffective, risks returning the drug market to an earlier era in which such improper marketing claims were rampant, likely at the expense of the publics health.
Under the Dietary Supplement Health and Education Act (DSHEA) the 1994 legislation that established the current regulatory framework for dietary supplements the FDA does not typically perform premarket reviews of dietary supplements, nor are manufacturers required to submit essential information about their products, including names or ingredients, to the agency prior to sale. This leaves the agency without clear visibility into what is on the market at any given moment. Despite near-universal knowledge of FDA disclaimers, many participants believed supplement claims were subject to FDA review, and they were skeptical about the FDAs ability to effectively regulate dietary products. For example, FDAs Statement on Identity, Nutrition, and Product Ingredient Labeling for Dietary Supplementss small-entity Compliance Guidance discusses complying with Agency regulations implementing the labeling provisions of the law; and using resources while continuing to coordinate effective, reciprocal relationships with other federal and state entities involved in addressing health fraud. Despite the dietary supplement industrys evolution into a multibillion-dollar enterprise, now costing more than $30 billion in the United States, regulatory agencies and researchers who study health services continue to learn little about the effects of the Dietary Supplements Disclaimer and how they affect consumers health behaviors.
The task force evaluated and weighed results from several studies that examined health outcomes associated with the use of beta-carotene and vitamin E supplements. It also found statistically significant increased risks for cardiovascular mortality associated with beta carotene supplementation. Recommendation The USPSTF advises against using beta carotene or vitamin E supplements to prevent cardiovascular disease or cancer. The Conversation asked Catherine Basbaum, clinical nutritionist at UVA Health, who specializes in cardiovascular diseases, to explain what the recommendation means for the general public, especially for people currently taking, or considering, supplements with the hopes of preventing, cancer and cardiovascular disease.
Whether there is heterogeneity within particular populations, or across levels of underlying nutrients, or socioeconomic factors like food insecurity, in the effects of vitamins, minerals, and multivitamin supplements on cardiovascular and cancer outcomes, especially among people who do not have known deficiencies and a lower prevalence of supplement use, and among ethnically and racially diverse populations. Further details are available in an accompanying summary of the evidence and the Evidence Report. In addition, USPSTF clarified that persons experiencing food insecurity are one population that is of interest to address a gap in research regarding whether effects of vitamin, mineral, and multivitamin supplementation on cardiovascular disease and cancer outcomes are different among particular populations. Because significant numbers of strains from the species Lactobacillus, Bifidobacterium, and yeast have long histories of safe use and are subject to rigorous evaluation and monitoring, a conclusion can be made that there are no significant safety concerns about their use in foods and food supplements in the general population. Many species of lactic acid bacteria, Bifidobacterium, and yeast, representing a majority of the commercially available probiotic strains, are considered safe for use in foods and supplements. This has created a growing market of increasingly diverse foods and supplements, particularly those that contain probiotics. The Agency acknowledges that there has been increased demand for some products in the course of the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective health products that can address the critical needs of the American public.