An Intervention to Address on Dietary and Natural Supplements Under Law in Virginia

To review evidence regarding effects of dietary supplements and interventions on mortality and cardiovascular outcomes in adults. The food additives industry is regulated by the FDA, mostly through DSHEE provisions.

Recently, The FDA has used Class I Drug Recalls to take adulterated dietary supplements containing pharmaceutical ingredients off U.S. markets. The regulatory challenge most closely examined with respect to the regulation of dietary supplements is that, unlike food additives, drugs, biological products, and medical devices, dietary supplements do not need premarket approval by FDA. It is my view that dietary supplements are inadequately regulated in the U.S.; however, these products should remain regulated as a subcategory of regular food products, with the goal of maintaining compliance with the scores of other influential food laws and regulations specific to particular products and/or ingredients (e.g., regulations on fish and seafood products should still apply to fish oil supplements).

Dietary and Natural Supplements Under Law in VA

In the European Union, dietary supplements are regulated as foods, with the legislative emphasis being on vitamins and minerals used as ingredients of food supplements. These only apply to supplements containing vitamins and/or minerals in which those products are regulated as foods, and address the ingredients of supplements, including their safety, purity, and bioavailability. In Australia, most food supplements are regulated in a complementary medicines category, including vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods for specific purposes and are regulated by food authorities. Dietary supplements can make generic health claims, nutrient-content claims, or structural-function claims. Some scientific evidence needs to be submitted only for health claims, that is, establishing a direct relationship between the use of supplements and reduced disease risk.

Dietary supplements are included under the health functional foods (HFF) category in Korea, regulated by The Ministry of Food and Drug Safety (MFDS) according to the HFF Law for the purpose of safety. Currently, an NDI notice is not required for dietary supplements, provided the supplements only contain food ingredients which were introduced into the food supply as articles used in foodstuffs, in the form that food has not been chemically altered. The most beneficial public health option, compared to using the majority of the dietary supplements on the market, except as noted above, is eating a diet consisting of a diet consisting of a variety of foods containing nutrients meeting all macro- and micronutrient requirements. Therapeutic diets, as well as laboratory tests to monitor the effectiveness of a diet plan, can be prescribed by a licensed dietitian/nutritionist, with the approval of, and permission from, a facilities health care or regulatory staff, and according to state laws.

Community-based housing settings permit the prescription of special diets to the individual physician or dietetician. Because hospitals in D.C. are among the few facilities not to state that a therapeutic diet should be prescribed by a doctor, we advise checking with D.C.s health department to see if there are any hospital regulations preventing hospitals from permitting RDNs who are competent from ordering therapeutic diets on their own. Given the requirement that nutrition services be in compliance with the physicians orders, we recommend working with California regulators to determine if California would permit RDNs to order therapeutic diets, and if it does not, to amend the statute to conform with CMSs revised rules. The D.C. Health Department reports they have no stand-alone regulations on food and nutrition services, instead complying with federal CMS conditions of participation.

The 2010 Food Safety Modernization Act (3) and 2002 Bioterrorism Act (4) are 2 notable examples of large pieces of legislation that apply to regular foods, which are also applied to food additives. The FDA regulates dietary supplement quality, safety, and labeling, while the Federal Trade Commission oversees advertising and marketing; however, there are large enforcement challenges, and optimum government oversight has yet to be achieved. Premarket approval has been ineffective in stopping approved or unapproved drugs from entering the market illicitly via vehicles like online sales.

There is no data available for these supplements in particular regarding their effects in relation to fibromyalgia or chronic pain. Supplementation with magnesium citrate has been shown to decrease the severity of symptoms in fibromyalgia. It is a supplement that has been indicated for both depression and osteoarthritis, making it an intriguing option for chronic pain.

Despite its humorous name, Capsaicin is an herbal supplement with a decent track record of efficacy for pain conditions. Given its high pain-depression co-existence, and given its generally good safety profile, SAMe is an adjunct worth considering for patients suffering from pain. At present, it seems prudent to evaluate vitamin D levels in patients with chronic pain and institute a low-level supplementation trial, given the safety of the supplementation and its potential for a positive effect on health in other areas in addition to pain. A small trial published after the Cochrane review of vitamin D supplementation in veterans found it improved pain, sleep, and quality of life. Other nutritional supplements, such as vitamin B 6, vitamin A, multivitamins, antioxidants, and iron, and dietary interventions, such as reduced dietary fat, had no meaningful effects on mortality or cardiovascular outcome (very low-to-medium confidence evidence). Omega-3 supplements are reasonably safe and can improve other aspects of health, such as lipid profiles. They may have a fishy taste and may trigger dyspepsia in some individuals; this is improved if the supplements are kept refrigerated.