The regulatory aspects of the food additives industry offer a backdrop to several areas of public health concern, including consumer behaviors regarding usage, safety, and effectiveness, as well as studies that address health effects from regular use of supplements. FDA regulates dietary supplement manufacturing, production, labeling, and packaging under the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 as an amendment to the federal food code. Dietary supplement companies are responsible for having evidence their products are safe and ensuring label claims are truthful and non-misleading. The federal Food, Drug, and Cosmetic (FD&C) Act defines a dietary supplement as a product, taken orally, containing a dietary ingredient intended to supplement a persons diet. Dietary supplements are available in a variety of forms–including tablets, capsules, powders, energy bars, and liquids–and are available over-the-counter at stores and online.
Further, there is no requirement that manufacturers provide evidence of product safety to the Food and Drug Administration prior to marketing a dietary supplement unless the supplement contains a new dietary ingredient (a dietary ingredient that was not marketed in this country prior to October 15, 1994) that has not been preserved in the food supply as an article used for food in a form in which the food has not been chemically altered. Further, there is no requirement for manufacturers to provide evidence of product safety to Food and Drug Administration prior to marketing a dietary supplement, unless the supplement contains a new dietary ingredient (a dietary ingredient that was not marketed in this country before October 15, 1994) that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered. The underlying framework of DSHEA allows any products marketed as food additives at the time of enactment of DSHEA, except for products in the context of new ingredients–this is what is known as a grandfathered)–that they are safe. Manufacturers are required to inform FDA prior to marketing of any new ingredients.
At the same time, we provided the FDA with a comprehensive set of enforcement mechanisms for acting on unsafe or misbranded supplements, including seizures, injunctions, civil monetary penalties, and even criminal penalties. CFSAN has also issued consumer advisories regarding unsafe products, such as an advisories that FDA issued regarding food additives that contained Kava, a botanical ingredient; it continues to engage the supplement industry regarding practices that are permitted under the Act. It is also clear that FDA plays a critical role in helping consumers use safe, high-quality dietary supplements, as well as protecting Americans from potential harms from products that fail to comply with the Agencys marketing standards.
Industry self-regulation is inadequate and ineffective for protecting the publics health and protecting the safety of patients, as unethical individuals and companies produce and distribute adulterated, misbranded, improperly labeled products, which present substantial risks. For example, the FDA does not require supplements labels to disclose how their products interact with other medications, which can result in unexpected side effects or irritations without adequate guidance from physicians. Enforcement focus on companies who fail to understand that is always welcome, as long as the FDA does not get creative reinterpreting rules intended by Congress for supplement products in a way that would diminish or harm consumers access to a wide variety of health-promoting supplements.
With a vast proliferation of manufacturers, and the attendant rise of the number and types of safety concerns, some companies have engaged independent product certification companies to ensure further security and minimize risks to consumers relying on dietary supplements. These steps include communicating with the public as early as possible when a dietary supplement is being challenged in the marketplace, ensuring our regulatory framework is flexible enough to appropriately assess the safety of products while promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies, and continuing to participate in a public dialogue to obtain valuable input from stakeholders on dietary supplements.
We are interested in hearing the other ideas all our stakeholders might have, and not only ideas that are limited to changes in law, so we can approach the challenge of regulating the dietary supplement marketplace in a manner that reflects where the industry is today, and continues to protect consumers ability to access safe, compliant dietary supplements over the next 25 years. We are interested in hearing other ideas all our stakeholders may have, and not just those limited to changes to the law, so we can go about the task of regulating the dietary supplement market in a way that reflects where the industry is today, and continue to safeguard consumers ability to access safe, compliant dietary supplements for the next 25 years. With respect to ongoing focus on regulating dietary supplements, the AHPA has been communicating consistently that we want the FDA not to release a third draft guidance for NDIs, which attempts to encompass both actual industry-needed guidance as well as the agencys most contentious legal interpretations, but rather focus only on the topics that are really needed to guide companies intending to sell ingredients everyone agree are, indeed, dietary supplements. We urge the agency to issue final guidance on new dietary ingredients (NDIs) that provides protections for innovation and research; establish and clarify a legal pathway to market for hemp-derived cannabidiol (CBD) as a dietary supplement; implement a mandatory product listing that provides transparency to regulators and consumers alike; and address concerns about N-acetyl-l-cysteine (NAC) and other ingredients that are shared between supplements and medications.
We urge the agency to release final New Dietary Ingredient (NDI) guidance that offers protection for innovation and research ; to establish and clarify a legal path to market for hemp-derived cannabidiol (CBD) as a dietary supplement ; to implement a mandatory product listing that provides transparency for regulators and consumers alike ; and to address the issues around N-acetyl-L-cysteine (NAC) and other ingredients that are shared among supplements and drugs. With a recent rise in the percentage of individuals reporting following restrictive diet patterns, such as those following a ketogenic, paleolithic, vegan, and vegetarian diets, supplementation is likely to have greater effectiveness to lower non-communicable diseases. The effectiveness of supplements in meeting the needs of these particular populations requires assessment. Overall, supplements are unnecessary, with exceptions for established deficiencies, and overconsumption of certain nutrients can increase the incidence of cancer. In certain cases, excess vitamin and mineral intake can be harmful or produce undesirable side effects; thus, maximal levels are needed to assure safe supplementation with foods. There is also increasing interest, especially in emerging economies, in the value for a traditional, accepted value for a GRAS food additive (generally recognized as safe). In the twenty-five years since the passage of the Dietary Supplement Health and Education Act (DSHEA), legislation that transformed the FDAs regulatory power over dietary supplements, the market for dietary supplements has grown dramatically.