Why Dietary Supplement Manufacturers Are In a “New York State of Mind”

Covance Botanicals BlogMakers of dietary supplements are keeping a close eye on New York after several major retailers were recently accused of selling mislabeled store-branded herbal supplements.

The allegations came after testing initiated by the state’s Attorney General’s office found that supplements, such as ginseng and echinacea, apparently did not contain the labeled ingredients. Although dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before being sold to consumers, they must be labeled correctly and safe for consumption. They also must, according to current good manufacturing practice, be tested using scientifically valid methods–in other words, “accurate, precise, and specific for its intended purpose.”1

This brings us to the reason behind the supposed missing ingredients.

It turns out that the researcher hired by the New York Attorney General’s office used DNA barcoding methodology to test the herbal supplements. Had the supplements been made of raw, herbal materials, this would have been entirely appropriate.

However, these products were comprised of herbal extracts–an important distinction. Why? Because the extraction process destroys the DNA of plant material, this makes it undetectable using barcoding methods. Because the manufacturing process eliminates DNA, barcoding was not a scientifically valid way to test these supplements. A more appropriate analytic technique, like high performance liquid chromatography (HPLC), would likely have provided entirely different results.

Despite the explanation, the mislabeling controversy continues to make headlines as other states consider initiating their own investigations. Adding fuel to the media fire, stimulants were recently found in some dietary supplements, sparking even more speculation and mistrust.

So what are retailers to do? Most of all, they need to have a good understanding of their supply chain, at every step of the way. Store-branded products are often manufactured by other companies. These manufacturers often source and process raw materials procured from other providers, creating a lot of opportunity for adulterants to be introduced to a product.

A rigorous testing program can help minimize that risk by ensuring that quality systems and practices are in place throughout the entire process–from raw materials to finished product. Scientifically valid testing is essential to ensure that a product is safe and has the ingredients it claims. Without it, companies are putting their brand, reputation–and most important–consumers, at risk.

By Jeff Stassi and Garrett Zielinski 

Jeff Stassi is the Senior Client Manager for Dietary Supplement Testing Services at Covance Laboratories. Mr. Stassi acts as the primary liaison for dietary supplement clients as well as providing expertise on designing comprehensive testing programs to meet scientific and regulatory requirements. Jeff has over 29 years of experience in laboratory operations and client program management and has set up testing programs for hundreds of clients within the dietary supplement supply chain.  

Garrett Zielinski is a Client Manager at Covance Laboratories. Mr. Zielinski acts as the primary liaison for dietary supplement clients as well as providing expertise on designing and managing testing programs to meet scientific and regulatory requirements. He participates in a number of organizations involved with the dietary supplement industry related to regulation and analytical testing. He has over 13 years of experience with organic synthesis and analysis of pharmaceuticals, and in the analysis of food and dietary supplements. 

1 http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm238182.htm