If the use of dietary supplements is an indication of how health-conscious people are, it would be easy to assume that Americans are living healthier today more than ever. According to the most recent survey spearheaded by the Council for Responsible Nutrition (CRN), the use of dietary supplements hit an all-time high in 2019 with 77% of American adults reporting they take dietary supplements.
With the recent COVID-19 pandemic underscoring the importance of boosting one’s immunity, it wouldn’t be a surprise if this number surges even more. As is, the dietary supplements industry is projected to be worth $56.7 billion by 2024.
It’s worth noting that according to the FDA, 31% of human foods in 2019 were imported. The FDA didn’t give a specific percentage, but the category of human foods include dietary supplements. Using this number as a ballpark, It’s safe to say that almost 1 in 3 dietary supplements that consumers buy either came from overseas or contain ingredients that were sourced from another country. For instance, Scott Steinford, the director at large of the Utah-based CoQ10 Association estimates that up to 90% of the ingredients used in US-manufactured dietary supplements are imported from China. Innovation in nutritional supplements knows no geographical boundaries, which is why a number of nutrition companies are eager to bring dietary products from overseas to American soil.
Dietary Supplements are Tightly Regulated
This eagerness has caused a number of nutrition companies to have a run-in with the authorities — either with the FDA or customs. Importing dietary supplements (and the related ingredients) are tightly regulated. Companies who are interested in procuring these products from overseas to sell in the local US market need extensive research, and if needed, consult with importation and distribution experts to ensure a successful product launch.
Companies who are keen on importing dietary supplements into the United States should be aware of the following common mistakes their predecessors have committed in the past.
1. Not Obtaining a Food Facility Registration
Whether a company is importing ingredients to locally produce a dietary supplement or importing a finished product, it must register its facilities with the FDA. This is in line with the Bioterrorism Act and the Food Safety Modernization Act. Aside from record-keeping, the registration of food facilities including those that are engaged in the business of nutritional supplements allows the FDA to inspect such facilities and suspend their operations due to certain circumstances.
2. Failing to Declare New Dietary Ingredients
The operative term “new” might cause some confusion among dietary supplements importers. Under the Federal Food, Drug, and Cosmetic Act, a “new dietary ingredient” means a “dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994.”
What can add to the confusion is that the FDA doesn’t keep a record of dietary ingredients that were marketed in the United States before the said date. It is up to the importers to perform due diligence. For supplements containing new ingredients as per the FD&C Act definition, importers need to provide documentary evidence such as relevant studies proving that these ingredients are reasonably expected to be safe at least 75 days before being introduced or distributed to consumers.
3. Non-Compliance with Labeling Requirements
The FDA requires five statements to be present on the label of all dietary supplements marketed and sold in the United States:
- The name of the dietary supplement
- The net amount of the dietary supplement
- The nutrition labeling
- The ingredients list
- The name and place of business of the manufacturer, packer, or distributor
Non-compliance with these labeling requirements may delay a company’s distribution and sales of imported dietary supplements in the country. If improperly labeled dietary supplements somehow made it to the shelves, the FDA can order a recall.
4. Making Inappropriate Claims
“What’s in it for me?” is a question all dietary supplements companies need to answer in order to sell their products. The FDA recognizes this and allows dietary supplements to make claims that fall under three categories:
- Health claims illustrate the relationship of a dietary supplement ingredient and the reduced risk of a health condition or disease. These claims need to be substantiated by a research commissioned by the company itself or an authoritative statement of a scientific body of the U.S. government. The FDA needs to review any health claim made by a dietary supplement prior to its distribution.
- Nutrient content claims describe the amount of a dietary ingredient in a supplement and may refer to ingredients for which there is not recommended Daily Value. These claims can also take the form of comparative-percentage claims versus other existing dietary supplements. A dietary supplement can be marketed with these claims provided that they are accompanied by a statement of the amount of the dietary ingredient per serving.
- Finally, Structure/Function and other related dietary supplements claims allow dietary supplements brands to three things. First, they are allowed to make general well-being claims. Second, they are allowed to make claims on how a particular dietary ingredient can improve or maintain a function of the human body (e.g. fiber helps maintain regular bowel movement). Lastly, companies are allowed to make nutrient deficiency disease claims to describe the benefit of a dietary ingredient to a nutrient deficiency disease (e.g iron-deficiency anemia), provided that they give statistics on how widespread the disease is in the United States. These claims can be made without prior FDA approval, but dietary supplement brands still need to submit substantiation to the FDA no later than 30 days a product is introduced to the market. Further, they need to make it clear that any claim they make were not reviewed and approved by the FDA.
What dietary supplement companies cannot do is make drug claims or claims that their products can diagnose, prevent, or cure a disease. For instance, despite the numerous studies that demonstrate the anti-inflammatory and antioxidant properties of turmeric, dietary supplements containing this ingredient cannot, under no circumstances, claim that they can prevent cancer or arthritis.
5. Not Understanding the Dietary Supplements Market
Complying with FDA regulations and other government laws is only half the battle. Companies who are interested in importing dietary supplements into the United States need to understand what it takes to get their products moving off the shelves. As mentioned, the dietary supplements market is a multi-billion dollar industry and competition is tough.
It’s advisable for companies who are keen on bringing dietary supplements to the United States market to partner with experts that know the landscape very well, not just in terms of regulatory requirements, but the needed sales and marketing strategies and tactics. “After working in the retail industry all my life, I knew the problems that companies, especially international firms, face when they want to enter the U.S. consumer market,” says Mitch Gould, the CEO and founder of Nutritional Products International (NPI), a company that helps both domestic and international companies with FDA compliance. The firm also has a proven track record in helping supplement brands come up with effective distribution, sales, and marketing strategies. “We have an FDA compliance expert to review the products’ labels. We have graphic artists to create the labels, website developers to build e-commerce sites, marketing professionals to promote the brand, and retail professionals who promote their products to retail buyers.”
Partnering with industry experts such as NPI may entail an initial investment, but given that the United States enforces some of the strictest and is one of the most competitive and complex markets in the world, getting everything right is tantamount to a company’s success.