NSF recently attended the China Health Product Ingredient Conference & International Sourcing Information Exchange Expo and participated in the launch of National Good Manufacturing Practices for Plant Extracts. At this conference, Ms. Li Sisi, Senior Manager of Global Certification, shared the topic of the U.S. dietary supplement market.

The U.S. Dietary Supplement Market and Regulation of FDA

According to the Mordor Intelligence report findings, the global dietary supplement market will grow at a CAGR of approximately 4.5% from 2024 to 2028. The global market size is expected to reach $166.2 billion by 2028. North America is currently the world's largest market for dietary supplements, while Asia Pacific is the fastest-growing market.

As one of China's important export markets, the United States has accounted for almost one-fifth of the export trade of dietary supplements for many years. In 2023, China's exports of dietary supplements to the United States amounted to $457 million.

Before entering the U.S. market, Chinese companies need to understand the risks and regulations they may face in order to face them effectively.

First, a brief review of the regulatory and standard developments in the U.S. dietary supplement industry. Dietary supplements are defined and regulated by the Dietary Supplements Health and Education Act of 1994. As the U.S. consumer market grows and more brands enter the market, a lack of industry standards and regulations also arises.

In 2003, NSF released the NSF/ANSI 173 Certification for Dietary Supplement Products. It is worth mentioning that at the beginning of April this year, Amazon rolled out its new Dietary Supplement Testing Program. The program features key elements of NSF/ANSI 173, the gold standard in the dietary supplement and functional food industries. Products certified to NSF/ANSI 173, NSF 229 and NSF Certified for Sport® are compliant with Amazon’s dietary supplement policy.

In response to changes in the U.S. market, NSF also launched the NSF/ANSI 455 standard in 2018, which addresses Good Manufacturing Practices for dietary supplement manufacturers and is the current Good Manufacturing Practice in the U.S., which allows retailers to bind their suppliers.

We often hear references to 21 CFR 111 and 21 CFR 117 in the industry. CFR is the abbreviation of Code of Federal Regulations. 21 CFR 117 focuses on food in a broad sense, and 21 CFR 111 specifies the manufacture and handling of dietary supplements. Recently, the FDA recommended that the two be combined to impose double constraints on the production of dietary supplements. This means that the raw material companies of dietary supplements need to add the identification of products or ingredients to it, which is also the biggest difference between 21 CFR 111 and 21 CFR 117.

21 CFR 111 and 21 CFR 117 contain requirements for cGMP. In contrast to the GMP, which stands for "Good Manufacturing Practices", c stands for current to remind manufacturers to use newer technologies and systems to comply with regulations. The standard is dynamic and can be updated based on existing market demand, regulatory updates, consumer feedback, retailer feedback, or cutting-edge research in the market.

According to FTC and FDA’s DSHEA and cGMP requirements, manufacturers and distributors must meet the following requirements:

• Maintain evidence that their products are safe and that product claims are true and not misleading.

• Comply with FTC (Federal Trade Commission) guidelines for advertising dietary supplements.

• Notify FDA of structural/functional claims no later than 30 days after the dietary supplement product is first marketed and keep the evidence on file. Even if you use a third-party manufacturer or distributor, you are responsible for quality assurance controls.

• Notify FDA of a new dietary ingredient at least 75 days prior to marketing (not available in the U.S. prior to October 15, 1994). The notification must include information about the safety of dietary supplements.

• Domestic and international facilities that register with FDA to produce, process, package, or store food (or dietary supplements/ingredients) for U.S. or animal consumption. Document, investigate, and forward to FDA any direct reports they receive of serious adverse events related to their product use.

• Comply with Federal Regulations (21 CFR 101.36) labeling requirements to ensure that each product is accurately labeled and ingredient, that the dietary ingredients are safe, and that the ingredient content is consistent with the amounts stated on the label.

NSF Certification Meets U.S. Retailer Requirements

NSF recently conducted a survey of 1,000 regular U.S. consumers who buy dietary supplements. The survey found that 74% of consumers prefer to shop at a supplement retailer that specializes in providing supplements that meet strict quality and safety standards. 82% of consumers expect retailers to inspect supplement manufacturing facilities, emphasizing the importance of quality control, while 86% expect retailers to only sell supplements that have undergone rigorous safety and quality testing. In addition, 66% of consumers believe that retailers should be held liable if they sell supplements that do not meet safety and quality standards, showing a shift in the division of responsibilities between retailers and manufacturers.

In the highly competitive U.S. dietary supplements market, it is crucial for manufacturers and suppliers to meet retailers' certification requirements. U.S. retailers have strict standards and guidelines that products must adhere to before they can be sold. It's important to note that up to 95% of consumers trust product claims from independently certified supplements. Therefore, third-party certification, such as NSF certification, is vital for manufacturers and brands to meet these requirements. For many U.S. retailers, NSF certification is sufficient for selling products both in physical stores and online. Retailers like CVS and Wegmans also have their own specific dietary supplement certification requirements. For instance, CVS necessitates third-party certification, while Wegmans recognizes NSF certification and its strict quality assurance standards.

NSF's product certification process includes rigorous testing, audits and product evaluations to ensure that products meet the highest quality and safety standards. NSF's current certifications services for manufacturers in China include NSF 173 GMP certification, NSF/ANSI 455 GMP certification, and NSF 229 GMP, which can help companies identify possible gaps in GMP compliance, understand the associated risks, and prepare for inspections by regulatory agencies.

NSF maintains NSF/ANSI 173, the national standard for certification of dietary supplement products, of which NSF 173 GMPDI is the eighth chapter of the Good Manufacturing Practice (GMP) registration requirements for dietary supplement. NSF 173 GMPDI registration demonstrates that the company is a cGMP-compliant supplier of high-quality supplement ingredients. NSF cGMP can meet the GMP requirements of retailers such as Amazon, CVS, Wegmans, Target, and Topco at the same time, avoiding the trouble of duplicate certification.

NSF/ANSI 455-2 GMP is a cGMP for finished dietary supplements, and it applies to the cGMP requirements of all manufacturers of finished dietary supplements. NSF/ANSI 455-2 GMP provides a globally recognized certification with the ANAB and NSF mark. It will also reduce the costs associated with auditing multiple independent standards for manufacturers.

For dietary supplement brands and formulation holders, NSF maintains NSF/ANSI 173, the National Standard for Certification of Dietary Supplement Products, as well as NSF229 for Nutritional Supplement Product Certification, which will directly meet all of the new dietary supplement policies in most North America.

NSF 229 PCCN is a nutritional supplement product certification service launched by NSF in China this year. Applicable to manufacturers, brands and distributors of functional food, beverage and nutritional supplement products, product certification mainly consists of three steps - facilities GMP audit, product label audit and product testing. Brands or manufactures  can obtain bilingual certificates in Chinese and English, which have stronger international applicability.

All certified manufacturers are publicly listed on the NSF website. To date, NSF has certified 1,000 Good Manufacturing Practice facilities around the world, about 20% of which are from Chinese manufacturers. We're excited to collaborate with more regional manufacturers to make sure their products meet specific standards and regulations, enable them to effectively join the American market, and enhance the reputation of their goods.