Validation of Ingredients and rules in Production of Natural and Herbal Dietary Supplements in Virginia and Maryland

Herbal Dietary Supplements

The Council for Responsible Nutrition, the leading dietary supplement industry association, called the NY AGs investigation uninformed, unconscionable, and unethical, and responded with an array of resources explaining why the DNA testing methods relied on by the NY State AG are not appropriate to determining dietary supplement contents, and thus cannot be trusted to provide an accurate or reliable accounting of dietary supplement contents. The Natural Medicines Database provides data for herbal products, dietary supplements, vitamins, minerals, homeopathic products, Ayurvedic medicines, complementary alternative medicines, integrative therapies, alternative healing modality (e.g., acupuncture), Traditional Chinese medicine products (fixed combinations), and other natural remedies. These analytical tools from USP are intended to assist with identifying and compiling ingredients used in pharmaceutical formulations and in DS products, and their catalogue of reference standards includes vitamins, minerals, phytochemicals, and compounded botanical products. Verification and certification programs for food additives and food additive ingredients may be used by manufacturers to assist with the assurance of quality in their products.

As with most foods, manufacturers of most dietary supplements are not required to submit proof of product safety to FDA before marketing. While the DSHEE does require manufacturers to label their products as supplements and provide a complete list of ingredients, manufacturers are not required to notify the FDA about adverse events reports that they might have received from consumers. For supplements that do not include the newest food ingredients that is, food ingredients not sold to the government prior to Oct. 15, 1994 there is no requirement that manufacturers submit proof to FDA about a products safety, before or after marketing. These include the requirement of a premarket notice for some new dietary ingredients, but the FDAs review of this notice is not comparable to the drug preapproval process. Furthermore, in contrast to the framework for drugs, compliance with a United States Pharmacopeia-National Formulary (USP-NF) standard for quality is voluntary for all dietary supplements.

These include a premarket notification requirement for certain new dietary ingredients, but FDA review of such notifications is not comparable to the preapproval process for drugs. Moreover, unlike the framework for drugs, conformance to a United States Pharmacopeia-National Formulary (USP-NF) public quality standard is voluntary for all dietary supplements. This scenario may potentially provide an incentive for manufacturers to state that their food ingredients or supplements meet public quality standards, such as those found in USP-NF, since a product may be considered a false brand when the products actually fail to conform to a public quality standard. Accordingly, the FDA regulates dietary supplement safety primarily by assessing aftermarket assessment whether the product is adulterated or misbranded pursuant to provisions of the Food and Drug Administration. DSHEA is intended to achieve a proper balance between providing consumers with access to safe dietary supplements they may choose to support and enhance their health, and providing FDA with regulatory power to act against supplements and ingredients in supplements if they are unsafe, prevent safety problems, or make false or misleading claims, or are otherwise promoted or misbranded. The regulatory aspects of the dietary supplement industry provide context to several areas of public health concern, including consumer behaviors regarding usage, safety, and effectiveness, and studies that focus on health effects of regular supplementation.

Although supplements are regulated by FDA, the scope of this regulation has frequently been contentious, and state authorities can use their consumer protection powers to address what is perceived by some to be gaps in the regulations. In addition, concerns about safety have been raised regarding both regular and higher-dose supplements. Tests have shown that some supplements are inconsistent with their labels, and that some supplements contain substantially less or more of their claimed amounts of key ingredients.

Dietary supplement products made with the same ingredients from different manufacturers may therefore differ in quality, as manufacturers use different specifications and different tests and methods to determine if these specifications are met. To address the needs of the industry and for research with quantified reference materials not tied to a single, standardized test, NIH-ODS has collaborated with NIST in developing CRMs for food ingredients and supplement products. In particular, using matrix-based reference materials allows researchers to evaluate the precision, precision, and sensitivity of analytic measurements of constituents in natural products, including dietary ingredients and their metabolites. In an environment of increased governmental oversight and consumer concerns regarding dietary supplement quality, USPs dietary supplement validation program may assist in strengthening manufacturers competitive positions and brand recognition while furthering manufacturers commitment to producing quality products for consumers.

Because industry has grown over the last quarter century from $4 billion in sales with approximately 4,000 products to $40 billion in sales with more than 50,000 products, modernization efforts are critical in protecting safety, increasing transparency, and beginning to adopt novel, innovative mechanisms to assure superior supplement quality. We encourage the Agency to publish a final new dietary ingredient (NDI) guideline offering protections to innovation and research; to set out and clarify the legal pathway for hemp-derived cannabidiol (CBD) as a food additive; to adopt mandatory product listings providing transparency for regulators and consumers alike; and to resolve issues regarding N-acetyl-l-cysteine (NAC) and other ingredients shared between supplements and medications. Since our last Enforcement Action Report in February 2015, FDA has issued warning letters to seafood processors, dairy, dietary supplement manufacturers, and other food companies for violations related to CGMPs (current best manufacturing practices), commodity-specific regulations, labeling, illicit drug residues, and unapproved drug claims. Responsible companies are meeting CGMP standards and continuing to look for ways to deliver safer, higher-quality products, and expanding and strengthening their supply chain processes all improvements that are helping to provide consumers with access to dietary supplements that they use to lead healthier lives. Under this authority, the Agency could further use quality metrics as an additional or alternative inspection approach for products that come from foreign facilities, potentially leading to lower inspection frequencies for top performers.