Natural and Herbal Dietary Supplements
We encourage the Agency to publish definitive new dietary ingredient (NDI) guidelines, which will protect innovation and research; to set out and clarify a legal pathway to sell cannabis-derived cannabidiol (CBD) as a food additive; to promulgate a mandatory list of products, which will ensure transparency to regulators as well as consumers; and to resolve issues regarding N-acetyl-l-cysteine, (NAC), and other ingredients commonly found in supplements and medications. For that reason, FDA will continue to work to supplement these measures with industry and consumer education efforts, and to continue to assist the dietary supplement industry with regulations and guidance documents that address dietary supplement manufacturing, labeling, and sales.
Unfortunately, a 1994 Act known as the Dietary Supplement Health and Education Act [DSHEA] has made it more difficult for FDA to act on, and to offer meaningful protections from, unsafe foods. The underlying framework of DSHEA allowed for all products sold as dietary supplements at the time of enactment of the act to remain on the market, except where FDA can demonstrate a safety issue in a specific product or product line this is what is known as a grandfather clause; manufacturers are required to inform the FDA before marketing any new ingredients. If the product contains a new dietary ingredient not sold in the U.S. before Oct. 15, 1994, food products required that a manufacturer or distributor inform Food and Drug Administration 75 days prior to introducing a product on the market, except if the product is a novelty.
Under the Dietary Supplement Health and Education Act (DSHEA) the 1994 act that established the current regulatory framework for dietary supplements–the FDA does not typically perform a premarket review of dietary supplements, nor is it required for manufacturers to give the agency basic information about their products, including names or ingredients, prior to marketing. This leaves the agency without a clear picture of what is on the market at any given moment. In the U.S., supplement safety is regulated by the U.S. Food and Drug Administration (FDA), but legal limitations inhibit FDAs ability to regulate dietary supplements effectively (e.g. This has increased risks to public health, and has led to many calls for reform. Dietary supplements, which include vitamins, minerals, plant and animal extracts, hormones, and amino acids ingested orally, are used extensively in the US, with four out of five adults reporting having taken one. The dietary supplement market has grown exponentially in the past 25 years from a $4 billion industry with 4,000 products in 1994 to one of over $40 billion today, with up to 8,00 products2 but consumer safety regulations have failed to keep up. In Australia, most Dietary Supplements are regulated within a complementary medicines category, including vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods for specific purposes and regulated by food authorities.
These only apply to supplements that contain vitamins and/or minerals, in those cases in which those products are regulated as foods, and address supplement composition, including its safety, purity, and bioavailability. This includes only products that fit the statutory definition of a dietary supplement under the U.S. Food and Drug Administration (FDA), with the exception of cannabis hemp products (CBD), which is explained below. Sales of herbal teas or cosmetics that have botanical ingredients are excluded. As an organizing body for standards aimed at public health, the USP supports manufacturers of dietary supplements in continuing their efforts to produce high-quality products to meet consumers needs.
At the heart of FDAs enforcement efforts is our commitment to strengthening the lawful production, sale, and use of dietary supplements, while protecting consumers from unsafe products, fraudulent labeling claims, and other unlawful practices. For example, FDAs Statement on Identity, Nutrition, and Ingredient Labeling for Small Entities Compliance Guide discusses complying with Agency regulations that implement the labeling provisions of the act; and resource utilization through continued coordination with other Federal and State entities engaged in health fraud prevention. Such regulations should be modeled on existing food Good Manufacturing Practices regulations, and they should not mandate standards for which no currently applicable, commonly available analytical methodologies exist.
It could be very time-consuming to develop the present system for voluntary reporting of adverse events that would identify the public health problems associated with improper supplement use. The story of ephedra supplements makes clear that it is incredibly difficult for the FDA to keep consumers safe from unsafe dietary products, and this is why Representatives Susan Davis, Representative John Dingell, introduced H.R. 3156, The Access Act, and Nutrition Additives Awareness. Meanwhile, more claims letters are written each year about food additives than any other product, so you cannot really claim it is unregulated when that is the area where the actions are obviously in place. I mean, we got letters [saying], You cannot make claims that it can cure, cure, or alleviate disease. I think that claim part has been relatively consistent, particularly when you have had somebody like Rich Cleland [assistant director, advertising practices, consumer protection bureau] in the Federal Trade Commission. Meanwhile, there are more claims letters on dietary supplements written every year than there are on any other commodity, so you can not really say it is not regulated when that is an area that there is clearly action on I mean, we have got 25-plus years of letters [saying] you can not claim to cure, treat, or mitigate a disease… I think the claims piece has been relatively consistent, especially as long as you have people like Rich Cleland [assistant director, Advertising Practices, Bureau of Consumer Protection] at FTC. Cassandra Soltis brings extensive experience at in-house, in-law, in-product, pharmaceutical, medical devices, cosmetics, etc. Bayne & Associates, and she advises clients in food, dietary supplements, drugs, medical devices, drugs, and beauty products. Most recently, Holly Bayne served as Marketing Manager at a California-based producer of nutritional and herbal supplements. Ms. Bayne began her legal career with the Hyman, Phelps & McNamara, P.C., the nations largest specialty law firm focused on food and drugs, where she regularly advised companies on various legal and regulatory matters.