Food Supplements
The dietary supplement, functional food, and natural products industries in the United States are facing numerous regulatory uncertainties with the start of 2021, which is marked by a new US Administration, ongoing global pandemic, and much more. By the second half of 2021, barring improvements from the current pandemic, we could expect attention to modernizing the Dietary Supplement Health and Education Act (DSHEA) from 1994, potential legislation regarding cannabis-derived cannabidiol (CBD) as a food additive, focusing on pesticides used in foods, and continuing discussions about the labeling of added sugars in foods.
We encourage the Agency to release final new dietary ingredient (NDI) guidance offering protections to innovation and research; establish and clarify a legal pathway for hemp-derived cannabidiol (CBD) as a dietary supplement; implement mandatory product listings providing transparency for regulators and consumers; enact a mandatory product list providing transparency to regulators and consumers; and to implement mandatory product listings providing transparency for regulatory agencies and consumers; and address issues with N-acetyl-l-cysteine-based products. CFSAN has also published consumer advisories regarding unsafe products, such as advisories that FDA issued regarding supplements that contain Kava, a botanical ingredient; continue communications with the supplement industry regarding practices that are permitted under the Act. In the U.S., supplement safety is regulated by FDA, however, legislative limitations have prevented FDA from effectively regulating supplements (e.g. This has increased the risk of health complications for consumers, and has led to many calls for reform.
In the European Union, food supplements are regulated like foods, with legislation focused on vitamins and minerals used as ingredients in 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.
Texas does not classify vitamins or dietary supplements as foods, but rather health products, which are exempt from sales tax. Texas does not typically impose sales taxes on vitamins and supplements. Vermont has a sales tax exclusion on foods and food ingredients intended for human consumption outside of a retail foods store.
R.I. Gen. Laws SS 44-18-30(9) provides an exemption from sales tax on food and food ingredients. SS 77.54 (20N)(A) gives exemptions, and also which items are included as food and food ingredients. SS 39-16-105(a)(vi)(e) exempts purchases of groceries for household use.
South Carolina generally exempts unprepared foods eligible for the federal food stamp program from sales taxes. It should be noted that nutritional supplements were exempted before South Dakota eliminated exempt status in 2005.
In 2005, the Codex Alimentarius adopted guidelines on vitamin and mineral food additives. In certain cases, excess consumption of vitamins and minerals can be detrimental or produce undesirable side effects; thus, maximal levels are required to assure safe supplementation with foods. Although the ADA does not typically endorse micronutrient supplements for individuals with diabetes, they do suggest that individuals at increased risk for micronutrient deficiencies (e.g., individuals following very-low-calorie diets, older adults, and strict vegetarians) might benefit from micronutrient supplements.
Although dietary supplement products cannot be marketed as treatments for or preventions of diseases claims may describe only how a specific nutrient or food component affects body structure or function manufacturers are not required to provide the agency with evidence that supports the claims that they make about their products. Even if they were, evidence supporting the use of supplements is mixed. In addition, if the labeling includes a claim that a product affects the structure or function of the body, a claim of overall wellness, or a claim about benefits related to classic nutritional deficiencies, the food supplement also must bear a disclaimer that says that Food and Drug Administration has not evaluated that claim, and the product is not intended to diagnose, treat, cure, or prevent any illness. The basic structure of DSHEA allowed all products marketed as dietary supplements at the time the Act was enacted to remain on the market unless the FDA could show safety problems with a particular product or line of products this is the so-called grandfather provision; manufacturers must notify the FDA before any new ingredients are marketed. Under the Dietary Supplement Health and Education Act (DSHEA) the 1994 legislation that established the current regulatory structure for dietary supplements FDA does not typically do any premarket reviews of dietary supplements, nor is it required to give manufacturers essential information about their products, including names or ingredients, before they are sold. This leaves the agency without clear visibility into what is on the market at any given moment.
Now, it is further complicated by the fact that the FDA has a number of current bureaucrats who loathe dietary supplements and who would like to gain approvals prior to marketing, thereby driving down the costs of vitamins, minerals, and even herbal products. The COVID-19 pandemic has intensified existing problems with the market for supplements. To legally be sold in China, each food additive has to receive the Certificate of Health Food Approval from CFDA, which indicates Chinas current emphasis on the safety and science-based evidence for the products function. 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. Such regulations should be modeled on existing good manufacturing practice regulations for foods, and they should not mandate standards that do not have current, commonly available analytical methodologies.