In the European Union, dietary supplements are regulated as foods, with the focus of the legislation being the vitamins and minerals used as ingredients of food supplements. In Australia, most dietary supplements are regulated in a complementary medicines category that includes 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.
As of July 1, 2014, West Virginia has a sales tax exemption on foods and food ingredients intended for human consumption. Although dietary supplements are not considered foods and food ingredients in West Virginia, July 1, 2014s bill exempting foods and food ingredients also applies to dietary supplements. SS 77.54 (20N)(A) provides exemptions, along with which items are included as food and food ingredients.
SS 67-6-228 provides a distinction between low-tax rates and high-tax rates on food products. Producers of ingredients accepted for use in foods, but prohibited for use in food additives, may petition for the cataloging of their ingredients.
Natural Supplements Regulations
For supplements not containing the new food ingredient–that is, the dietary ingredient not sold to the government prior to Oct. 15, 1994–there is no requirement for manufacturers to submit proof of product safety to FDA, 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. It is important to note that the FDA does not have authority to review dietary supplement products for safety and efficacy prior to marketing. Recently, the U.S. FDA has used Class I drug recalls to take adulterated dietary supplements containing pharmaceutical ingredients off U.S. markets.
The FDA regulates the quality, safety, and labeling of dietary supplements, while the Federal Trade Commission oversees advertising and marketing; however, there are large enforcement challenges, and the best state surveillance has yet to be achieved. In the atmosphere of increased government oversight and consumer concerns regarding dietary supplement quality, USPs dietary supplement certification program may help strengthen manufacturers competitive positions and brand recognition, while furthering manufacturers commitment to producing quality products for consumers. Safety Monitoring The main mechanism to monitor the safety of supplements is the voluntary reporting system established by FDAs Centers for Food Safety and Applied Nutrition called the Centers for Food Safety and Applied Nutritions (CAERS) E-Reporting System. While the DSHEA does require manufacturers to label their products as supplements and provide a complete ingredient list, manufacturers are not required to notify FDA about adverse event reports that they might receive from consumers.
Dietary supplements can include generic health claims, nutrient-content claims, or structural-function claims. Some scientific evidence only needs to be submitted to the FDA for health claims that demonstrate a direct connection between use of the supplement and reduced risk for illness. A 2002 Harris Poll found that 59% believe supplements should have been approved by a governmental body such as The Food and Drug Administration before being sold. In South Korea, separate ingredients have to be approved by KFDA (Korean Food and Drug Administration) in order to make health claims, while Japan requires final product approval. I think that the FDA is trying to establish, through our provisions, a pathway to qualifying health claims, whether it is conventional foods or food additives, where, if there is substantial scientific agreement, then the claims are not disputed; otherwise, there might be claims that can be made depending on the extent of the science so far.
To legally sell in China, each dietary supplement has to get the certificate from CFDA of Health food approval, which indicates Chinas current emphasis is much more on the safety and science-based evidence for function. With over 90,000 different supplements available in the market, it is difficult to know which ones are safe or unsafe. Tests have shown that some supplements have contents that are inconsistent with their labels, and that some have substantially lower or higher amounts of their claimed key ingredients.
Second, supplements and other natural products are not necessarily safe and may have potent, medication-like effects. Non-dietary supplements (herbs and botanicals, metabolites) are not food for pets, but instead may fall under regulation as medications. Some botanicals are considered to be traditional medicinal herbs, used in medicinal products and food supplements alike.
Edible chews (rawhide, hoof, pyzzle) are also a type of animal feed, according to law, but can be exempted from state registration and labeling requirements in certain circumstances. Animal feeds and pet foods are regulated at the state level, with each state having its own requirements, forms, and fees. If you follow AAFCOs model regulations, you can likely comply with all of your states requirements. Check out AAFCOs Model Animal Feed Regulations and the Animal Feed Labeling Guide for details. The AAFCO Model Regulations give you the rules on registration/licensing, labeling, ingredients, and best manufacturing practices (processing or making the food). The regulations address the registration of products and/or the licensing of your company that is required for distribution of pet food to individual states, ingredients used in food, making of the food, and labeling (including labels and other materials, such as booklets) of the food. Most state laws require the registration of animal feeds or products, and some states may require that your company obtain licenses to sell products in that state.