This is a myth. Development of the Regulatory Infrastructure for Dietary Supplements. The Pure Food and Drugs Act of was enacted primarily to protect consumers from misbranded and adulterated foods and drugs moving in interstate commerce, motivated by public indignation at dishonesty and fraud in the marketplace. With its principal emphasis on foods, the Act prohibited any poisonous or deleterious substance that is injurious to health to be used in food.
In , the industry won a major victory with passage of the Proxmire Amendment, which prevented FDA from classifying vitamins and minerals as illegal drug products based on potency, or establishing maximum limits on the potency of vitamins and minerals in foods for special dietary use. In , Congress passed by unanimous consent clarifying legislation Table 1.
DSHEA emerged as viable legislation, promising both a sustainable solution to years of FDA-industry antagonism, as well as the potential to bring the stability, predictably, and transparency expected of a fully regulated industry.
In the watershed decisions concerning black currant oil made from seeds of Ribes nigrum, Grossulariaceae , then marketed as products by Traco Labs, Inc. In fact, some in the dietary supplement industry have maintained that, rather than actively collaborating with the responsible majority of the industry, FDA chose a regulatory posture of studied inertia, hoping that wildcat fringe marketers would cause an implosion of the industry as a whole, resulting in a backlash against DSHEA or even its repeal.
Today, there appears to be both strength of purpose from the mainstream industry and its trade associations to defend DSHEA, encourage member compliance with existing FDA regulations and guidances, and engage in more robust self-policing.
In her testimony before Congress, Jane E. In January , FDA issued a long-awaited final regulation governing dietary supplement labeling claims, establishing criteria for determining when FDA would object to a statement in dietary supplement labeling because it impermissibly suggests an effect on disease.
In other areas, however, FDA took a rigid and limiting approach, curtailing speech that is arguably within the scope of dietary supplement claims authorized by DSHEA i. Also in January , fulfilling Dr.
Levitt, Esq. Notably, however, real progress and finalization of key standards for dietary supplements, namely in the form of GMP regulations, were delayed. Yet, high-acuity hindsight must appropriately recognize the complexities of the issues requiring a disciplined and deliberative approach to developing a rational and sustainable regulatory infrastructure for a major industry.
The court also found that FDA was not arbitrary and capricious in its Final Rule banning ephedrine alkaloids and ephedra, and that FDA had met its evidentiary burden to justify a total ban.
Notably, the ephedra situation highlighted a safety-related and post-marketing surveillance gap that had yet to be filled by FDA—mandatory reporting of serious adverse product experiences associated with dietary supplements. In December , the Dietary Supplement and Nonprescription Drug Consumer Protection Act DSNDCPA was signed into law, requiring companies engaged in the sale and distribution of dietary supplements and non-prescription over-the-counter OTC drugs to maintain records of all adverse event reports received by a company, to report all serious adverse events to FDA, and to make such reports available to the agency on request.
Additionally, a serious adverse event includes medical or surgical intervention, based on reasonable medical judgment that is necessary to prevent any of the outcomes listed above.
In considering a range of enforcement options available to the Agency, FDA will also conduct a risk-benefit analysis of the product under section f of the FDCA to determine whether the dietary supplement presents a significant or unreasonable risk to public health or presents an imminent hazard. Following industry outreach efforts, FDA published a proposed rule in The dietary supplement GMP regulations mandate that manufacturers of dietary supplements establish a comprehensive system of controls and strictly document each stage of the manufacturing process to help ensure that products have the identity, purity, strength, and composition stated on product labels and that finished dietary supplements meet clearly defined specifications in the manufacturing record and are not adulterated.
The final rule establishes the minimum current GMP necessary for activities relating to the manufacturing, packaging, labeling, and holding of dietary supplements to ensure product quality.
Issuance of the final dietary supplement GMP regulations marked a major regulatory achievement for FDA and significantly raised the bar of compliance for dietary supplement manufacturers. Notably, the regulation allowed for a 3-year staggered compliance period, with large companies or more full-time employees becoming subject to the rule in June , followed by medium companies the following year and small companies fewer than 20 employees in June of FDA GMP inspections of dietary supplement facilities have risen progressively from 12 in to 75 in Both FDA and industry are supported by non-governmental organizations in meeting their respective twin goals: FDA to ensure that dietary supplements are safe and not adulterated under the law; and industry to ensure compliance and that only properly labeled dietary supplements meeting technical standards of quality reach consumers.
The United States Pharmacopeial Convention USP is a nonprofit scientific organization that has been setting standards for food and drug ingredients since as part of its mission to improve the quality and safety of foods and drugs moving in international commerce.
Since that time, USP has published many botanical, vitamin, mineral, and other dietary ingredient quality monographs. To qualify for development of a monograph, the dietary ingredient must pass a USP safety review, according to defined criteria. USP also develops and publishes both general and specific standards, tests, assays, and other specifications for use in raw ingredient quality control operations and the manufacture of finished dietary supplements.
Under the program, manufacturers that demonstrate adherence to quality control procedures and undergo an audit may include a USP quality designation mark on dietary supplement labeling.
To qualify for use of the USP-DSV mark, the dietary supplement must pass laboratory testing to confirm dietary ingredient identity, potency and purity, and batch-to-batch consistency. FDA and the industry are also supported by the work of AOAC International, a nonprofit organization founded in , dedicated to the development of analytical methods.
AOAC maintains a committee structure to engage in the prioritization of methods development, based on ingredient market share and public health needs, among other factors. The purpose and responsibilities of ODS include promoting the scientific study of dietary supplements and serving as a principal advisor to FDA on issues relating to dietary supplements.
Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in agency guidances means that something is suggested or recommended, but not required. April Contains Nonbinding Recommendations. Some of the important events relating to the labeling of dietary supplements include: The Nutrition Labeling and Education Act of amended the Federal Food, Drug, and Cosmetic Act the act in a number of important ways.
Notably, by requiring that most foods, including dietary supplements, bear nutrition labeling. The Dietary Supplement Health and Education Act of the DSHEA amended the act, in part, by defining "dietary supplements," adding specific labeling requirements for dietary supplements, and providing for optional labeling statements.
On September 23, 62 FR , we implemented the DSHEA by publishing several key regulations on the statement of identity, nutrition labeling, ingredient labeling, and nutrient content and health claims for dietary supplements. On June 5, 63 FR , we amended the regulations pertaining to the nutrition labeling of extracts used in dietary supplements. Because dietary supplements are intended to supplement the diet, their processing and manufacture are regulated by the U.
Food and Drug Administration FDA in a manner similar to food, with some differences that will be outlined in this report. In contrast with the authority under which drugs and medical devices are regulated, dietary supplements are regulated as food under the Federal Food, Drug, and Cosmetic Act FFDCA , and the FDA does not take regulatory action on food or dietary supplements until something goes wrong with a product that is on the market.
The FDA has the authority to take action regarding supplements that are labeled incorrectly misbranded or contain unsafe ingredients adulterated. The FDA is made aware of potential misbranding or adulteration through inspections, adverse event reports, and citizen petitions.
According to public opinion polls, the American public overwhelmingly assumes that FDA reviews the safety and effectiveness of dietary supplements before they are marketed. While this is the case for drugs and medical devices, it is not the case for dietary supplements. Consumers, the health care and dietary supplement industries, Congress, and federal regulators all have a stake in supplement identification, effectiveness, and safety.
Current federal policy toward regulating dietary supplements was intended to balance these competing interests. DSHEA provided FDA the authority to take action against products that were unsafe or adulterated, but emphasized that FDA should not take actions that would impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers.
As the supplement market has grown and diversified, the regulatory and research questions have become more complex. This report discusses current areas of regulatory and legislative concern, including the identification of products as dietary supplements, their role in individuals' health and health care, and recent issues regarding supplement safety. Dietary supplements are marketed for nutritional support and health promotion, as well as for a number of other uses, including weight loss and sports performance enhancement.
These products come in pill, capsule, and liquid form, as well as in forms that may appear similar to conventional food or beverages.
Dietary supplement use is common in the U. Dietary supplement production has increased over time. The number of dietary supplements on the market rose from 4, in to approximately 55, in This report outlines the authority of the Food and Drug Administration FDA to regulate dietary supplements and summarizes dietary supplement-specific regulations for new dietary ingredients NDI , good manufacturing practices GMP , labeling, and claims.
The report also discusses adverse event reporting for dietary supplements and other means of ensuring consumer safety through enforcement of these authorities and regulations. Finally, the report concludes with a discussion of policy issues related to the manufacture, regulation, and use of dietary supplements, including the identification of dietary supplements, the role of dietary supplements in health and health care, and dietary supplement safety.
The Food and Drug Administration, U. The agency has the authority to deem food and dietary supplements misbranded i. DSHEA made changes to FDA's authority that differentiated certain aspects of dietary supplement regulation from regulation of conventional foods, in regard to 1 new dietary ingredients 14 NDI , 2 good manufacturing practices GMP , 3 labeling, and 4 certain health claims for dietary supplements. Subsequent legislation provided FDA with additional authorities. Under the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, Congress added requirements for mandatory reporting of adverse events for dietary supplements.
The Office of Regulatory Science , in conjunction with the Office of Applied Research and Safety Assessment , manages and conducts the safety assessments, compliance, and regulatory programs relevant to dietary supplement labeling requirements and claims of unsafe, adulterated, or contaminated dietary supplement products. FDA has the authority to take enforcement action against misbranded i. It may also ban an ingredient through the rule-making process.
Under the FFDCA, a dietary supplement is considered adulterated under specified circumstances related to the product's contents and manufacturing processes: A dietary supplement is considered misbranded if it is inaccurately labeled or presents unapproved claims. Under current law, the burden of proof of misbranding or adulteration is on the agency, and this is specific to dietary supplements. Unlike food manufacturers, dietary supplement manufacturers are required to report serious adverse events to the FDA.
In contrast to drugs, dietary supplements and their ingredients are generally presumed safe; also unlike with drugs, the FDA does not have the authority to require safety and efficacy testing for dietary supplements before they enter the market.
Although processors, manufacturers, and packers of dietary supplements are expected to adhere to FDA regulations when bringing a new product to market, there is no pre-market approval process for dietary supplements. However, prior to entering the market, the FDA must be notified of dietary supplements containing New Dietary Ingredients, and of dietary supplements containing certain claims.
After a supplement is on the market, FDA has the authority to deem dietary supplements misbranded or adulterated if they are inaccurately labeled, contain unapproved NDI, or contain harmful ingredients, and may issue warnings or order a mandatory recall in certain circumstances. The following sections provide details on FDA's dietary supplement-specific authorities, regulations, and guidance on NDI, GMP, labeling including packaging, inserts, and information at the point of sale , claims, and serious adverse event reporting.
A NDI is defined as a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, For these grandfathered dietary supplement ingredients, manufacturers are required to maintain records that document their use prior to October 15, As long as documentation of grandfathered status exists, a product may be marketed without any evidence of efficacy or safety of its ingredients.
The manufacturer of a NDI marketed after that date must give 75 days' premarket notification to the FDA, and must provide a history of use or other evidence of safety when used under recommended conditions. FDA has not proposed a timeline for the revised guidance. For each NDI, manufacturers are required to submit notifications to the FDA, and the ingredient must either 1 have been present in the food supply as an article used for food in a form in which the food has not been chemically altered, or 2 be accompanied by evidence supporting a "reasonable expectation of safety" under the recommended conditions of use.
According to FDA's draft guidance, for ingredients that are not grandfathered or if a manufacturer is unable to produce the relevant documentation to confer grandfathered status the manufacturer would have to re-characterize the ingredient as a NDI and follow the relevant regulatory process.
Dietary supplement processors, manufacturers, and packers are responsible for ensuring that a dietary supplement or dietary supplement ingredient is safe by following GMP. These regulations were finalized in , 40 and largely addressed the concerns raised by the industry. Dietary supplement GMPs contain sections that detail additional quality control procedures and recordkeeping requirements for each step in the manufacturing process. FDA noted in the final rule that "the focus of GMP is on process controls to ensure that the desired outcome is consistently achieved, and not on the inherent safety of the ingredients used.
GMP for dietary supplements apply to all domestic and foreign companies that manufacture, package, label, or hold a dietary supplement for import and sale in any state or territory of the United States, the District of Columbia, or Puerto Rico. Although dietary supplements are generally considered food for purposes of FDA regulation, they have different labeling requirements set forth under the FFDCA. Dietary supplement labeling includes packaging, inserts, and information at the point of sale.
The FFDCA required that foods contain labels with certain nutritional information, but it was not until the s that food labeling regulations were authorized and promulgated. Dietary supplement labels are required to have the following information:.
In addition to the required labeling, the FFDCA permits but does not require manufacturers to make certain types of claims about supplements' benefits. A nutrient content claim is one that expressly or implicitly characterizes the level of a nutrient in a dietary supplement.
Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition 65 for example, "While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.
For the FDA to authorize use of a health claim on dietary supplement labeling, it must meet certain criteria. Health claims may also be authorized based on authoritative statements from federal scientific bodies. Another type of health claim, known as a qualified health claim, may also be used for dietary supplements. Qualified health claims are based on less scientific evidence than the SSA required for other health claims, but must be approved by the FDA however, they are not required to be authorized in statute or an authorizing regulation.
In addition to health and nutrient content claims, dietary supplement manufacturers are allowed to make statements describing the role of their nutrients' or dietary ingredients' intended effect on the structure or function of the body.
It must also state that the dietary supplement product is not intended to "diagnose, treat, cure, or prevent any disease. Dietary supplements are not required to undergo premarket review for safety. In order to identify safety issues, the FDA mainly relies on information provided by manufacturers under the adverse event reporting system. The FDA created a voluntary adverse event reporting system for supplements in The Dietary Supplement and Non-Prescription Drug Consumer Protection Act, 81 enacted in , required several changes to the adverse event reporting system for dietary supplements.
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