Herbal Supplements
The FDA regulates herbal supplements by different standards from foods, OTC drugs, and prescription drugs. FDA regulates food additives under a different set of regulations from the ones that cover food and regular medication products. The food additives industry is regulated by FDA, mostly through provisions in DSHEE. The FDA regulates dietary supplements safety, manufacture, and labeling, and the Federal Trade Commission has primary responsibility for regulating advertising for these products.
For example, Food and Drug Administrations Statement on Identity, Nutrition, and Product Content Labeling for Dietary Supplementss small entity compliance guidance discusses complying with Agency regulations that implement the labeling provisions of the bill; and using resources through continued coordination with other federal and state entities involved in addressing health care fraud. For that reason, FDA will continue to pursue efforts to supplement these measures with industry and consumer education, and continue to assist the dietary supplement industry through rulemakings and guidance documents that address dietary supplement manufacturing, labeling, and sales. Food and Drug Administration regulates dietary supplement quality, safety, and labeling, and Federal Trade Commission regulates advertising and marketing; however, there are significant enforcement challenges that still exist, and the best government oversight has yet to be achieved. Now, this is complicated further by the fact that the Food and Drug Administration has many sitting bureaucrats who detest dietary supplements, and who would like to see premarket approvals pushed back, thereby driving down the costs of vitamins, minerals, and even herbal products.
In addition, concerns about safety have been raised regarding regular, high-dose supplementation. FDAs Center for Food Safety and Applied Nutrition has more reports of adverse events related to artemisinin-containing food additive products not included in this review (FDA, unpublished data, 2009). Although it is commonly used in the herbal supplements of American manufacturers, artemisinin was not available in the U.S. for medical use until recently, with the exception of by the CDC through the Investigational New Drug Protocol. Artemisinins have been available without prescription in the U.S. as herbal supplements for at least 10 years; these supplements are marketed for general health maintenance as well as treatment for parasitic infections and cancer.
Some botanicals are considered traditional medicinal herbs, and are used in medicinal products as well as in food additives. Non-nutritional supplements (herbs and botanicals, metabolites) are not food for pets, but may instead fall under the regulatory umbrella of medicines. Although considered supplements in some jurisdictions, in most, probiotics are regulated as foods. In the European Union, dietary supplements are regulated as foods, with the law focused 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. Dietary supplements may include generic health claims, nutrient-content claims, or structural-function claims. Some scientific evidence only needs to be submitted to FDA for health claims, that is, establishing a direct relationship between use of supplements and reduced risk for disease. In Australia, most food additives are regulated in a complementary medicines category, including vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods with specific uses and regulated by food authorities. The act places dietary supplements under a specific subcategory within the broad heading of foods, but products falling within a medicines definition are subject to regulation as medicines.
To legally be sold in China, each dietary supplement has to receive the Health Food Approval certificate from the CFDA, which indicates Chinas current emphasis on the products safety and scientific evidence of function. The production and sale of animal feed is heavily regulated both by the Federal Government and by 50 states. In California, the regulation for pet food is done by the California Department of Public Health. Animal feeds and pet products are regulated on a 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. You need to comply with regulations in every state you sell product to. Regulations address product registration and/or your business licenses required for pet food distribution in the individual states, ingredients used in food, manufacturing of the food, and labeling of the food (including labels and other materials, such as brochures). The AAFCO model regulations give you the rules for registration/licensing, labeling, ingredients, and best manufacturing practices (processing or manufacture of food).
Because the feed laws in each state are very different, because of that, many companies feel that it is easier to label their products according to the AAFCO model rather than trying to follow all of the various versions of the feed laws and regulations that are adopted in each state. The EUs food additives directive can also be used as a template for other countries, as well as in preparing the Codex Alimentarius regulations. Health-care providers should be aware that patients may take herbal supplements that contain artemisinin, and should consider asking about use of these supplements for patients evaluated for hepatitis with no obvious etiology.
Herbal supplements may also potentially interact with other medications and diminish or intensify their effects, which may include toxicity. Mg deficiency is seen either through decreased absorption (as seen with patients who have a poor diet with a lot of processed foods) or increased elimination (as seen in individuals using alcohol, caffeine, or taking diuretics or contraceptives). Although the ADA does not typically advocate using micronutrient supplements for diabetics, they recommend people at increased risk of micronutrient deficiencies (e.g., people following very-low-calorie diets, older adults, and strict vegetarians) might benefit from multivitamin supplements.