Worldwide Awareness of Natural Supplements
The dietary supplement, functional food, and natural products industries in the United States are facing numerous regulatory uncertainties with the start of 2021, which is marked by a new US Administration, ongoing global pandemic, and much more. The Food and Drug Administration regulates quality, safety, and labeling for dietary supplements, while the Federal Trade Commission oversees advertising and marketing; however, there are vast challenges to enforcing regulations, and optimum government oversight has yet to be achieved. The FDA regulates dietary supplements through a set of regulations distinct from the regulations that cover conventional foods and drugs. Dietary supplements are included under the health functional foods (HFF) category in Korea, regulated under the Health Functional Foods (HFF) Act by the Ministry of Food and Drug Safety (MFDS) for the purpose of safety.
Dietary supplements may include generic health claims, nutrient-content claims, or structural-functionality claims. Some scientific verifications are required to be submitted only to the FDA for health claims that demonstrate a direct relationship between the supplement use and a reduction of the risk for diseases. These only apply to supplements that contain vitamins and/or minerals, in cases in which those products are regulated as foods, and address supplement composition, including safety, purity, and bioavailability. In the European Union, food supplements are regulated as foods, with the legislation focused on vitamins and minerals used as ingredients of food supplements. In Australia, most dietary supplements are regulated in a complementary medicines category that includes vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods for specific purposes and are regulated by food authorities.
Dietary supplements are regulated differently from conventional foods and medicines by the U.S. Food and Drug Administration (FDA). Pharmaceuticals undergo the rigorous FDA approval process before entering the market; medications are considered unsafe until proven safe. It is difficult to forecast FDAs ability to inspect and enforce regulations on dietary supplements in 2021 because of the still uncertain nature of COVID-19 and associated variables, such as vaccine (s) availability. 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 focused on health effects of regular supplementation. Under DSHEA, supplement manufacturers are not required to demonstrate safety or efficacy; Rather, DSHEA deliberately minimizes U.S. Food and Drug Administration supervision and emphasizes the industrys value to the U.S. economy.
FDA regulates dietary supplement manufacturing, production, labeling, and packaging through the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 as an amendment to the federal food code. Companies manufacturing dietary supplements are responsible for having proof of safety and ensuring label claims are truthful and non-misleading. As the dietary supplement industry continues to grow, and patients continue to use dietary supplements, FDA revisions and updates and the FDAs and Federal Trade Commissions oversight of the dietary supplement industry are needed. In an environment of increased governmental oversight and consumer concerns regarding dietary supplement quality, USPs dietary supplement review program may assist in strengthening manufacturers competitive positions and brand recognition while furthering manufacturers commitment to producing quality products for consumers. We encourage the Agency to publish final new dietary ingredient (NDI) guidelines offering protections to innovation and research; to establish and clarify the legal pathway for hemp-derived cannabidiol (CBD) as a dietary supplement; to implement mandatory product listings providing transparency for regulatory agencies and consumers alike; and to address issues regarding N-acetyl-l-cysteine (NAC) and other ingredients 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. The U.S. Drug Enforcement Administration has an educational resource on dietary supplement safety and information, the supplement 4111. Other, more comprehensive resources are available, although they may require paid membership. If you are receiving food supplements, you also may be eligible for participation in SNAP-Ed or Maines food supplement employment and training program.
To qualify for a credit, the hiring organization for a food industry job must have had a current supplemental wage program on April 16, 2020, paying a worker at or above the rate that a worker is entitled to under California law. For a non-food-sector hiring entity to receive a credit, the hiring entity must retroactively pay the difference between what it paid under its voluntary COVID-19 supplemental paid sick days policy and what is now required by California law. Executive Order N-51-20 provides for the payment of supplemental paid sick time (COVID-19 Supplemental Paid Sick Time) for workers in the food industry employed by a hiring entity with 500 or more employees across the country in certain circumstances related to the COVID-19 pandemic. The legislature has also extended eligibility for COVID-19 Supplemental Paid Sick Leave to other employees not employed by the food industry under recently passed Labor Code Section 248.1. For example, a non-food industry employer might already provide employees with certain hours of paid sick time related to COVID-19 from March 4, 2020, through September 19, 2020, but might not have compensated workers for those hours in a manner required by the California COVID-19 Supplemental Paid Sick Leave Act (the higher of regular rate of pay, the prevailing rate of the state minimum wage, or the prevailing local minimum wage). In response to COVID-19 and related laws, the Family Independence Bureau has made several temporary changes to safety net programs, including the Food Supplement. Enforcement focus on companies who do not figure it out is always welcome, as long as FDA does not get creative reinterpreting rules Congress intended to apply to Supplement products in a way that would diminish or undermine consumers access to a wide variety of health-promoting supplements.