An integral part of a pharmacist’s role is counseling patients on the proper use of OTCs and dietary supplements (DS). While OTCs are developed under the OTC Monograph or the New Drug Application processes, DS are regulated under the less rigorous Dietary Supplement Health and Education Act (DSHEA) of 1994. DHSEA requires that DS are manufactured free of contaminants or adulterants.

One source of trusted information is the US News and World Report list of Top Recommended Drugs and Treatments, which is published annually. It ranks pharmacists’ recommendations on OTCs and DS. For example, in the 2020 report Nature Made fish oil, coenzyme Q10, essential vitamins, flaxseed oil, and herbal supplements were ranked #1 by pharmacists.

The DS manufacturers are responsible for evaluating the safety and labeling of their products to ensure that they meet federal regulations prior to marketing. The FDA only becomes involved if a product is found to be adulterated or misbranded once it has already reached the market. Problems that may be encountered with the use of DS include microbial and heavy metal contamination, prescription drug adulteration, substitution of active plant variety or enrichment of the DS, and fraudulently underdelivering ingredients. Given these concerns, how can a pharmacist be assured that the DS that he/she is recommending meets the highest quality standards?

The answer is third-party certification. Third-party certification is the procedure whereby an independent organization reviews the good manufacturing practices (GMP) of a DS and determines if the marketed product meets specific standards for safety, quality, or performance. In May 2019, a consensus statement was published on the essential features of third-party certification programs for DS.

Three of the major third-party certification/verification programs are (CL), NSF International (NSF), and US Pharmacopeial Convention (USP). All of these are fee-based voluntary programs; NSF and USP are not-for-profit organizations. Products that have successfully passed analysis of their quality, safety, performance, and claims of benefit are issued a U.S.-registered certification mark. These testing agencies help guarantee that the DS contains the ingredients included in the product labeling. All of these certification companies obtain the DS product independently from a public source and not directly from the manufacturer.

CL, which has the oldest certification program that dates back to 1999, offers a Quality Certification Program and also conducts Product Reviews. Product testing is conducted in the same manner within both of these programs. Testing methods and standards are based on USP, the World Health Organization and California Proposition 65. While all results are proprietary to the manufacturer, CL may post Product Reviews for products that have passed the certification process on their website. These Product Reviews are accessible to the public for a fee.

The CL Seal of Approval indicates that the product has passed quality tests, which establishes that it contains the ingredients listed on the label in the declared potency and amounts; safety tests indicating that it is free of harmful contaminants; performance tests demonstrating that the product meets USP standards for disintegration and dissolution rates; and it has supported indication claims with the claim of health benefits being consistent with regulatory requirements. CL also publishes a yearly report on dietary supplement consumer trends and preferences.
Similar quality, safety, performance, and claims requirements need to be met by NSF and USP in order for products to earn their quality seal.

NSF is a standards-writing body accredited by the American National Standards Institute, which has led the development of more than 100 standards over the past 75 years. In 2003, the NSF started its verification programs and now offers three certifications: NSF Product Contents Tested and Certified Mark, NSF Certified for Sport Mark, and NSF Good Manufacturing Practices (GMP) Registered Mark. Results of these analyses are proprietary. While the former certification is comparable to CL and USP, the Certified for Sports program further analyzes DS on a lot-by-lot basis for the presence of more than 200 banned athletic substances.

DS that pass the NSF Content Tested and Certified analysis may carry this mark on their product packaging and advertisements, whereas those that pass the NSF Certified for Sport may only carry the Certified for Sport Mark on the specific lot of product tested. The NSF also carries out annual product reviews and testing and biannual GMP auditing. The NSF GMP Registered Mark can be used on facility promotions but not on product packaging or advertisements.

The USP program started in 2001. It assures that DS are manufactured in accordance with FDA current GMPs as well as USP’s own GMP standards. Further, CL and USP both follow strict California Proposition 65 guidelines for safety. USP requires that its mark cannot be used in conjunction with other marks or seals of approval. USP conducts an annual on-site facility audit to assure that GMPs are being followed. Products must meet USP-National Formulary specifications, if available. If a DS meets the requirements of the DS Verification Program, the manufacturer is able to use the USP Verified Mark on product labeling/packaging and advertisements. Over 100 different dietary supplements have received the USP Verified Mark and a listing of these can be found at https:// USP also has a patient education brochure entitled “Choose Your Dietary Supplement with Confidence.”

Patient education tools about using DS wisely have been published by the American Pharmacists Association, the National Institutes of Health, Consumer Reports, and the FDA.  

The above listed tools are useful for pharmacists to help judge quality and safety when recommending DS to their patients. This is especially important since a study from 2012 found that only 12% of DS were certified by an independent scientific agency. The FDA has also taken note and in February 2019 the agency described new efforts to strengthen regulation of DS by modernizing and reforming FDA oversight.

In April 2019, the FDA initiated a new program, the DS Supplement Ingredient Advisory List, which serves as a rapid response tool to quickly alert the public when the FDA identifies ingredients that appear to be unlawfully marketed in DS. In May 2020, it convened its first meeting of the Botanical Safety Consortium. The purpose of this consortium is to provide a forum for scientists from government, academia, consumer health groups, industry, and nonprofit organizations to work collaboratively to generate a sound scientific basis for integrating existing safety data and the latest toxicology tools to evaluate botanical safety in DS.  

When one considers the availability of third-party certifications, published pharmacists’ recommendations, and FDA initiatives, now more than ever pharmacists have tools at their disposal to help them recommend safe and effective DS.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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