License Required for Dietary Supplements and Natural Supplements Under Law in Virginia

License Required Under Law for Dietary and Natural Supplements in Virginia

The U.S. Food and Drug Administration, or FDA, has regulations on dietary supplement products based on the Supplement Health and Education Act of 1994. In January 2011, the Food Safety Modernization Act was signed and contains many provisions affecting dietary supplements (U.S. Department of Health and Human Services; FDA 2013). In 2016, the FDA issued guidelines regarding what constitutes a new food additive and specified mechanisms to inform the agency about a new food additive (US Department of Health and Human Services; Food and Drug Administration; Center for Food Safety and Applied Nutrition 2016).

If the food contains a new dietary ingredient, which is one that was not sold in the U.S. before Oct. 15, 1994, the FDA requires that a manufacturer or distributor inform the FDA 75 days prior to marketing of the food, unless the new dietary ingredient has been introduced into the food supply as a food use article. A dietary supplement manufacturer making a statement of claim shall have evidence to show that the statement is true, is not misleading, and shall notify. The Food and Drug Administration that its product makes such a statement within 30 days after the marketing of the product that makes the statement. For supplements that do not contain the newest dietary ingredients, i.e., the dietary ingredients not sold to the Government prior to Oct. 15, 1994, manufacturers are not required to submit proof to The Food and Drug Administration about a products safety either before or after marketing. Under this Act, manufacturers of food additives do not need approval from FDA before making, labeling, distributing, and marketing their products.

Accordingly, FDA regulates dietary supplement safety primarily by postmarket assessment whether the product is adulterated or misbranded, as provided in Food. The U.S. Food and Drug Administration (FDA) plays a critical role in assuring the safety of vitamins, minerals, botanicals, probiotics, amino acids, and glandular extracts sold as food additives in the U.S. The U.S. Dietary Supplement Health and Education Act (DSHEA) sets a regulatory framework for food-like dietary supplements via the FDA.

Texas does not consider vitamins or dietary supplements to be foods, but rather to be medical supplies, which are exempt from sales taxes. Other dietary supplements sold as medicines, tonics, or as liquids, powders, granulars, tablets, capsules, lozenges, and pills are not considered food products and are subject to sales tax. Some states treat supplements as food items, as they typically bear nutrition facts labels instead of supplements facts or medication facts labels.

A supplement store makes money selling sports nutrition products, diet supplements, wellness products, and healthy foods. In doing this, the supplement store may gain extra sales on the premises, as well as gaining extra income through classes, sponsorships, and memberships at local fitness facilities.

You may also want to work with a top-tier supplement manufacturer who has already certified its line and has all of the necessary resources in place to produce and label a line of supplements to your own branding. If you wish to design your own nutrition formulas and produce supplements yourself, you will have to get certifications and extra insurance. To sell supplements through offline as well as online channels, you do not need to get a license. Within US borders, you must follow rules and regulations on selling supplements, as well as follow guidelines on manufacturing and nutrition labeling.

The biggest factor that needs to be analysed and ensured that you are doing it correctly is the labeling, because the last thing you want is to commit a violation and have your supplements taken off the market even before the sales process begins. Labels should describe products as food supplements, state all ingredients and nutrition facts, show the supplements facts panel, and give the manufacturers name, location, and contact information (2005). The FTCs role and advertising standards are the same for dietary supplements as they are for other products, such as foods; promotion of dietary supplements should be truthful, not misleading, and supported by scientific evidence.

To put it another way, supplement products are not manufactured to demonstrate quality, safety, and effectiveness the way that pharmaceutical products are. It should be noted that supplements were exempt before the 2005 South Dakota elimination of exemptions.

FDA maintains a publicly accessible database listing brands of supplements that it has identified as containing drug adulterants, as well as actions, if any, taken to take products out of circulation. In 2020, the FDA issued nearly 200 warning letters and other actions against companies that manufacture food additives, for reasons including making unsubstantiated claims, mislabeling products, failing to comply with CGMP standards, or selectively dispensing adulterated raw materials and using them in finished products. Only in 2012 did the FDA finally start using its full enforcement powers, including warning letters, product seizures, and forced recalls, to take stimulant #1 off supplements. My colleagues and I informed FDA early in 2017 that we identified 2 experimental stimulants, 1,4-dimethylamylamine and Octodrine,8 found in supplements. One of these stimulants has never been approved for use by FDA in humans, while the other was approved for use in the 1940s through inhalation, but has since been taken off the market.

Mexico (among others) is moving towards requiring food labels, and we speculate this will extend to other countries, and potentially supplement labels. One practical change would be requiring companies to register supplements with FDA before selling them, and Congress could give FDA more effective enforcement tools, such as immediate withdrawal of product registrations if it is found that supplements are adulterated with pharmaceutical drugs.