10 Dietary Supplement Industry Regulations New Brand Owners Can't Ignore
If you're relatively new to the dietary supplement industry, there's little-to-no doubt that you've heard about or are familiar with GMP's or Good Manufacturing Practices. If you aren't, I highly suggest doing your research on them before reading this article or proceeding with starting your own dietary supplement line.
If you've done your GMP homework, I applaud the work you've done, but I'm also here to tell you that there's plenty where that came from...
Despite what the public might think, the dietary supplement industry is highly regulated and as a new brand owner, there are a host of regulations and laws that you should familiarize yourself with to ensure your brand (and the consumers that purchase your product) are protected in the long run.
To help simplify things for you, the following is a brief overview of the top 10 dietary supplement industry regulations and laws that you absolutely cannot afford to ignore:
Food, Drug, and Cosmetic Act of 1938 (FD&C)
FD&C is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. This includes the definition of foods, and issues surrounding food adulteration and claims associated with foods. With the passage of the Nutrition Labeling and Education Act of 1990, and the subsequent passage of Dietary Supplement Health and Education Act of 1994 (both discussed below), FD&C was amended to more specifically address and regulate dietary supplements.
Nutrition Labeling and Education Act of 1990 (NLEA)
The law gives the FDA authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims (for example, 'high fiber', 'low fat', etc.) meet FDA regulations. It also established a select group of authorized Health Claims characterizing the relationship of any substance (e.g., a specific food or component of food) to a disease or health-related condition, and the conditions under which the Health Claim could be made. In most cases these claims are not applicable to dietary supplements, although there are a select few which may qualify, such as the claim defining the relationship between:
- Calcium, vitamin D and osteoporosis,
- Folate and neural tube defects,
- Soy protein and risk of coronary heart disease, and
- Plant sterol/stanol esters and risk of coronary heart disease.
Dietary Supplement Health and Education Act of 1994 (DSHEA)
This is a statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111 (see follow discussion about this). DSHEA spells out regulations regarding the manufacture and sale of dietary supplements, and defines a dietary supplement as “a product (other than tobacco) intended to supplement the diet that bears or contains one of more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient noted in clause (A), (B), (C), (D), or (E).”
To expand on this, this may include individual or combination vitamin and mineral supplements, herbal supplements, certain limited types of hormones (e.g., melatonin, DHEA), certain biological substances (e.g, glucosamine sulfate, chondroitin sulfate), and specialty products containing any combination of the aforementioned ingredients. The products might be formulated for a variety of intended purposes, including but not limited to promoting energy metabolism, reducing the effects of stress, alternative and complementary health therapies, promoting weight loss and providing sports nutrition benefits.
The act defines permissible labeling claims, including structure/function claims, and outlines safety requirements for new dietary ingredients. Structure/function claims will be further discussed later in this module.
The Food and Drug Administration Modernization Act of 1997 (FDAMA)
FDAMA amended the FD&C relating to the regulation of food, drugs, devices, and biological products. With the passage of FDAMA, Congress enhanced FDA's mission in ways that recognized the Agency would be operating in a 21st century characterized by increasing technological, trade and public health complexities. Relevant to the dietary supplement industry, FDAMA provides for health claims based on an authoritative statement of a scientific body of the U.S. government or the National Academy of Sciences. From a practical standpoint, this generally doesn't happen.
Current Good Manufacturing Practices (cGMPs)
These regulations stipulate current good manufacturing practices for dietary supplements, requiring that proper controls are in place for dietary supplements so that they are processed in a consistent manner to meet identity, purity, strength, and composition quality standards. cGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S. All supplement companies are required to maintain cGMPs, and to have a program in place to audit all contract manufacturing, packaging and distribution facilities that they use, to verify compliance with cGMPs.
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act)
The Bioterrorism Act directs the Food and Drug Administration (FDA) to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply (including dietary supplements) and other food-related emergencies. To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that food facilities register with FDA, and FDA be given advance notice on shipments of imported food. Registration pertains only to facilities that manufacture/process, pack, or hold food, as defined in 21 CFR 1.227, for consumption by humans or animals in the U.S.
Consumer Health Information for Better Nutrition Initiative of 2003 (CHIBNI)
In this initiative, FDA acknowledged that consumers benefit from more information on food labels concerning diet and health, and so established interim procedures whereby "qualified" health claims can be made not only for dietary supplements but for conventional foods as well. CHIBNI provides for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. The qualifications used for most of these claims are too onerous to be of value. One exception is the qualified health claim for Omega-3 fatty acids and coronary heart disease: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [Name of the food] provides [ ] gram of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat, and cholesterol content.]”
Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
This act addresses, among other issues, the labeling of foods (including dietary supplements) that contain certain food allergens. Under FALCPA, a "major food allergen" is an ingredient that is one of the following five foods or from one of the following three food groups or is an ingredient that contains protein derived from one of the following: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts or soybeans.
Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006
This Act requires compliance with the adverse event reporting and record keeping requirements prescribed for dietary supplement manufacturers, packers, and distributors.
Food Safety Modernization Act of 2011 (FSMA)
FSMA was enacted to prevent widespread occurrences of food-borne illness. FSMA includes a requirement that companies manufacturing, processing, packing or holding human food identify food-safety hazards and implement preventive controls. This may include manufacturers of dietary supplements.
How NutraScience Labs Can Assist You
At NutraScience Labs, our team possesses more than 50 years of nutraceutical contract manufacturing experience and understands of the aforementioned dietary supplement industry regulations and laws. We leverage our knowledge and make it easy for new brand owners to manufacture high-quality capsule, powder, and tablet product that comply with industry standards.
For more information on how we can assist you, please call 855-492-7388 to speak with one of our knowledgeable representatives or send us your request to receive a free price quote in 48 business hours.