A 2024 consumer survey by the Council for Responsible Nutrition (CRN), a leading trade organization in the dietary supplement and functional food industry, showed that three-quarters of people in the US use dietary supplements. These numbers have grown slowly from earlier years, with a typical monthly spend of 50 USD.
The data also shows that brand loyalty is a hallmark of the dietary supplements industry, with purchases from healthcare professionals reaching a median monthly spend of $100. The information in this survey reflects the trust consumers place in this FDA-regulated industry when making decisions to support their health and wellness goals.
Current Status of Compliance in the Dietary Supplement Industry
Despite the trust and reliance, a small but vocal community continues to oppose the use of dietary supplements, citing that they are not regulated by the US Food and Drug Administration (FDA) and, hence, are unsafe. This is not true.
The FDA regulates dietary supplements through the Code of Federal Regulations (CFR) and various Acts of Congress in the areas of labeling, mandatory adverse event reporting, current good manufacturing practices (cGMP), and facility registration. In addition, the Federal Trade Commission (FTC) regulates advertising associated with dietary supplements. The only unregulated aspect by either the FDA or the FTC is the pre-market approval.
Dietary supplements only need pre-market notification when the brand holder makes certain structure-function claims. However, the brand holder must use only those dietary ingredients in their supplements that have been approved for use in foods. A few dietary ingredients were grandfathered because of their use before the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), and are now classified as “old” dietary ingredients.
The Role of Analytical Testing in Compliance
The cornerstone of safety and regulatory compliance in the supplements industry is developing specifications and testing dietary ingredients against those specifications, either by a third-party testing laboratory or the brand holder’s in-house laboratory. The labs must be cGMP-compliant as detailed in the Title 21 Code of Federal Regulations (21 CFR) Part 111—the current cGMP in manufacturing, packaging, labeling, or holding operations for dietary supplements.
FDA inspectors or consumer safety officers visit registered cGMP sites routinely to investigate complaints of injury, illness, or death caused by an FDA-regulated product, such as a dietary supplement.
After such an inspection, the FDA inspector may create a report of objectionable conditions found (FDA Form 483) or, if the situation(s) found present a significant risk to consumers, issue a Warning Letter. The inspected cGMP sites should then develop and execute a plan of appropriate corrective actions to deal with the identified situations and offer a process-based solution to prevent recurrence.
Creating Specifications for Dietary Ingredients and Supplements
The dietary supplement brand holders and their contract laboratory testing partners are not collaborating to their full potential and for mutual benefit. Many brand holders are unaware of the composition of their dietary supplement product, and often outsource their responsibilities and obligations to a contract manufacturing organization (CMO).
The cGMPs require the brand holder, not the CMO, to generate a specification for each ingredient used to manufacture their dietary supplement. Each specification must include identity, purity, and strength of the ingredient, establishing the limits of types of contaminants that may (or lead to, thereof) adulterate the finished dietary supplement. Similar requirements are needed for the supplement’s composition and for in-process control points, which are typically go/no-go situations.
When a brand holder sets out to create a dietary ingredient specification, they often adapt and/or emulate a potential supplier’s specification. This overlooks their responsibility to ensure that the specification is meaningful and protects consumers from a potentially dangerous and unsafe product.
Partnering with Testing Labs for Robust and Reliable Processes
The knowledge of what should be in a dietary ingredient often resides with the contract testing laboratory, as they have more experience and insights into potential issues with a dietary ingredient. From a business perspective, extensively testing dietary ingredients is more cost-effective than dealing with an issue in the finished dietary supplement.
Additionally, many contract testing laboratories offer consulting services, such as food safety, to drive new customers for their base testing. Typically, though not directly related to analytical testing, one must be aware that these services are often competitive and not peer-reviewed, even those provided by established labs or companies.
Essentially, to meet their clients’ evolving needs, contract testing laboratories should consider moving away from a catalog of analytical tests, opening up their databases, and perhaps using AI, offer customized testing. Above all, the labs should ensure analytical testing and consulting services—customized or not—are robust and compliant with industrial regulatory standards to minimize costs, mitigate finished product failures, and prevent product recalls when they reach the marketplace.
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