The Supplement and Nutraceutical Regulations and Agencies You Need to Know
For the budding dietary supplement company or entrepreneur, any time is a great time to sit down and take a closer look at the major federal and local agencies, regulations, and trade associations that monitor the supplement industry.
Especially for those who may be new to the industry, information about these agencies can prove incredibly valuable. Regardless of where your supplement business may be, if it’s your intention to sell your products in the US, those products must meet all FDA/FTC manufacturing, marketing, and regulatory specifications for dietary supplements. More than anything, keeping up to date with the agencies and associations on this list can help brand owners and other nutraceutical industry players to keep customers happy and safe while also nurturing their businesses brand and reputation.
Every supplement and nutraceutical manufacturer should be aware of industry agencies but also where in their business processes those agencies have jurisdiction.
The FDA is the most obvious player here. The government agency not only sets rules and regulations but also provides consumer education and updates to the general public.
It regulates both dietary ingredients and finished dietary supplement products and does so under a separate set of regulations than those that govern conventional products consumed as foods and drugs. While individual firms are responsible for evaluating all product labeling and safety concerns prior to marketing, the FDA holds responsibility for taking action after a misbranded or adulterated dietary supplement reaches the market.
Since supplements fall under the category of foods according to federal law, they can also wander into the jurisdiction of the FTC.
This agency’s primary responsibility falls under claims in advertising and the health and fitness claims that dietary supplement companies make in their marketing. To achieve its goals, the FTC coordinates with the FDA and consults the expertise of other authorities including the National Institutes of Health (NIH).
When it comes to enforcement, the FTC has the authority to:
- Take action against “unfair or deceptive acts or ”
- Investigate complaints or trade practices that might be questionable.
- Stop violations of the FTC Act.
- Pursue civil penalties for violations.
- Challenge and stop unsubstantiated advertising.
- Negotiate consent orders or begin processes that result in cease and desist
Beyond those two major players, there are multiple, third-party organizations that also exercise power in the supplement space:
The NSF (National Sanitation Foundation), which issues certifications for products and systems in the world of dietary supplements. It also offers testing services and training capabilities. Popular certifications include: GMP, Gluten-free, SQF and Organic
QAI (Quality Assurance International – A Division of NSF) which is a USDA-accredited organic product certified agency and a leader in the organic industry. It offers certification programs for supplement manufacturers as well as educational and training resources.
The US Department of Agriculture (USDA) provides general information and resources on dietary supplements and offers organic certification and accreditation of organic products by allowing private, foreign, or state organizations to certify processing facilities or farms.
Project Non-GMO isn’t a government agency and instead is a nonprofit organization that takes on the mission of building and protecting a non-GMO food supply by educating consumers and conducting outreach programs. The organization also provides merchandising materials and training resources to retailers.
ConsumerLab.com is a privately held company that publishes test results on health, wellness and nutrition products. It also operates a proprietary certification program.
LGC is a world-renowned sports doping control and research laboratory. LGC operates Informed Choice and Informed Sport testing and certification programs for the sports nutrition industry”.
There are also multiple trade associations devoted to the world of dietary supplements.
The Council for Responsible Nutrition (CRN) represents dietary supplement and functional food manufacturers as well as ingredient suppliers. Membership with the council includes the expectation to comply with certain state and federal regulations that govern the manufacturing, quality control, marketing, and safety of dietary supplements.
The Natural Products Association (NPA) boasts a status as the nation’s oldest and largest non-profit dedicated to the natural products industry. With more than 1,400 members, it maintains a strong lobbying presence in D.C. and serves as a watchdog of regulatory and legislative issues.
If herbal products are an area of interest, then you should check out the American Herbal Products Association (AHPA). The organization works with federal agencies including the FDA, FTC, and USDA to promote responsible commerce of herbal products.
Considered the “trade association for 21st-century natural health product companies,” the United Natural Products Alliance (UNPA) has more than 25 years of experience representing dietary supplement, natural product, functional food, and science and technology related service companies around the globe.
Dietary Supplement Regulations
Understanding the regulations that apply to a dietary supplement can be complex, especially considering that each state and ingredient will be subject to different rules and laws.
On a broad level though, there are a few, major regulations that all manufacturers should be aware of.
Food Drug and Cosmetic Act of 1938
Amended over the years the FD&CA is the overarching regulation for foods and their subset, dietary supplements, which are specifically regulated under the DSHEA amendments to the FD&CA.
Dietary Supplement Health and Education Act of 1994
Frequently referred to as DSHEA, this act expanded the powers of the FDA and established a definition of the term “dietary supplement.” It also set up standards and definitions around labeling for products in the industry. While supplement ingredients aren’t necessarily scrutinized before they enter the market, the FDA does have the power to restrict how a substance may be sold if it’s found to pose “unreasonable risk” when used in the common manner or as the label.
The FDA also provides additional industry guidance. While non-binding, these regulations cover the Dietary Supplement Current Good Manufacturing Practices (DS cGMP), who is subject to regulations, procedures, personnel, production and process control, product returns and complaints, labeling guides, as well as other detailed and general provisions.
The FTC and Native Advertising
With the prominent shift toward influencer marketing, it’s possible that quite a few brands and brand representatives are violating FTC guidelines around disclosure of product sponsorship and relationship with a brand. To help address this and other related issues, the FTC has issued this guide for businesses as well as a Q&A-structured endorsement guide.
Overall, it’s most important to simply stay on top of news in this area. For example, on June 13, the FDA indefinitely delayed the Nutrition Facts and Supplement Face Label and Serving Size rules which were scheduled to go live on July 26, 2018. Changes like these should be expected, especially between government administration changes and are something manufacturers should make strategic efforts to stay on top of.