Concentrated Rules and Regulations on Natural Supplements in Virginia and Maryland

Rules and Regulations on Concentrated Natural Supplements in Virginia and Maryland

Complete food labeling information is available from Code of Federal Regulations, Title 21, Part 101-Food Labeling. Food labeling regulations were established by FDA, and the Commonwealth of Virginia follows those labeling regulations. Accordingly, the FDA regulates dietary supplements safety primarily by postmarket assessment whether the product is adulterated or misbranded pursuant to provisions of the Food.

The food additives industry is regulated by The Food and Drug Administration, primarily under provisions of DSHA. Under that Act, dietary supplement manufacturers do not need approval from FDA before they manufacture, label, distribute, and market their products. FDA regulates dietary supplements through a set of regulations that differ from the regulations that cover conventional foods and drugs. For instance, FDA does not require supplements labels to disclose how their products work with other medications, potentially leading to unexpected side effects or irritations if physician recommendations are not followed.

DSHEA is intended to achieve a fair balance between providing consumers with access to safe food additives they can choose to support and enhance their health, and giving FDA regulatory power to act against supplements and ingredients in supplements if they are unsafe, or if they make false or misleading claims, or are otherwise promoted or misbranded. Unfortunately, 1994 legislation known as The Dietary Supplement Health and Education Act [DSHEA] makes it very difficult for The Food and Drug Administration to take action and to offer meaningful protections against unsafe products. The FDA regulated dietary supplements on quality, safety, and labeling, while The Federal Trade Commission monitored advertising and marketing; however, there were still enormous enforcement challenges, and the governments best surveillance was not achieved. Monitoring Safety The main mechanism to monitor the safety of supplements is the voluntary reporting system established by FDAs Center for Food Safety and Applied Nutrition, called the Center for Food Safety and Applied Nutritions (CAERS) Supplement E-Reporting System.

For supplements that do not have any novel food ingredients, which is food ingredients not sold to the government prior to Oct. 15, 1994, manufacturers are not required to submit proof of the products safety to the FDA, before or after marketing. To qualify for exemptions from labeling on the Nutrition Facts, and to avoid having to submit documents to the FDA, the company must be either a retailer that has an annual gross sales volume not exceeding $500,000, or has an annual gross sales volume of no more than $50,000 for foods or food additives sold to consumers, or has less than 10 employees, and that has sold fewer than 10,000 units per year. There are two categories where an exemption from nutrition facts labeling can fit; a) no filing is required to FDA in order to qualify for exemption, and b) filing is required to FDA to qualify for exemption.

SS 77.54(20n)(a) provides exemptions, along with which items are included as foods and ingredients. Although food additives are not considered foods and food ingredients in West Virginia, SS 77.54, the act on July 1, 2014, to exempt foods and food ingredients, also applies to dietary additives. It should be noted that nutritional supplements were exempt prior to the 2005 repeal of exemptions in South Dakota.

Texas does not count vitamins or nutritional supplements as foods, but as medical supplies, which are exempt from sales taxes. SS 67-6-228 provides a distinction between a lower tax rate for food products and a higher one. 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.

In the European Union, dietary supplements are regulated as foods, with the legislation focused on vitamins and minerals used as ingredients of dietary 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. To legally be sold in China, each dietary supplement must receive the Certificate of Health Approval from CFDA, which indicates Chinas current emphasis on the safety and scientific evidence of function of products.

Mexico (among others) is moving towards requirements on front-of-labeling of foods, which we speculate will extend to other countries, and perhaps supplement labels. We encourage the Agency to publish definitive new dietary ingredient (NDI) guidelines offering protections to innovation and research; establish and clarify the legal pathway for the marketing of cannabis-derived cannabidiol (CBD) as a food additive; adopt a mandatory product list providing transparency for regulators and consumers alike; and address issues regarding N-acetyl-l-cysteine (NAC) and other ingredients shared between supplements and medications. The EUs food additive directive can also serve as a template for other countries, as well as in preparing the Codex Alimentarius regulations. The Food Safety Modernization Act has dramatically changed how foods are regulated, and has moved the power from FDA to farm where food is grown. Their responsibility is to prove that an additive poses a health hazard, a task that is hard to do, meaning that suspected additives could sit on shelves for years.