The authenticity and efficacy of dietary supplements (DS) have been a concern for many years now. And, on Tuesday, February 3, the New York State Attorney General’s Office announced a state-wide recall of herbal supplements sold through multiple major retailers (link to story). The recall is a result of a study conducted by authorities that found that many of these products were fraudulent and potentially dangerous. Supplements called into question include products said to contain Ginkgo Biloba and St. John’s wort, amongst others.
Unfortunately, the rules and regulations that have been implemented by the Food and Drug Administration (FDA) in the U.S. for governing the authenticity of food and beverage products are not the same for DS. When I last visited the FDA site in Irvine (California), they gave a very informative presentation in which they talked about the various regulations that govern the DS market. For example, the Dietary Supplement Health and Education Act of 1994 (DSHEA) states and, I quote verbatim from their presentation, that:
- Dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed.
- FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.
- FDA is responsible to ensure compliance of product information, such as labeling, claims, package inserts, and accompanying literature.
- FDA Final rule 21 CFR 111 – All foreign and domestic companies that manufacture, package, label or hold dietary supplements including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (cGMPS) for quality control.
- Manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States.
Here is how the DSHEA differs from the Drug cGMPs:
- No registration or preapproval of products
- No FDA approval of dietary supplements
- Process and method validations not required
- Analytical methods should be Scientifically Valid
- Product label must be truthful and not misleading
Here is the expectation from the FDA, and, again I quote verbatim from their presentation:
- Specifications of manufacturing process, components, labels, packaging materials and finished products set by firm must be met and, when not met, conduct material review.
- Identity testing of dietary ingredients required:
- C of A from qualified vendor is acceptable that includes test methods, limits, lot results with specifications.
- Vendor qualification: Confirm C of A through confirmation of tests
The FDA experts also informed us of the issues that they have seen in the DS market, such DS adulterated with added pharmaceutical drugs and steroids, or contamination with toxic metals (Pb, Se, Cr, Cd) and other substances. Some years back, the FDA also looked at dietary supplements contaminated with various pesticides, so that is another type of contamination that is of concern to the FDA. So yes, the FDA is aware of the problems facing the DS market and are doing their best to address them. Check out these two informative webpages maintained by the FDA for more information on the FDA efforts:
Like what you are learning?
- Q&A on Dietary Supplements (link to page)
- Beware of Fraudulent Dietary Supplements (link to page)
At Thermo Fisher Scientific Inc., our scientific experts are also looking at the DS market to come up with instrumentation, methods and techniques to help solve the various testing challenges. From the authenticity of raw materials to the analysis of the final product for label claims, we have done it all. In terms of our instrumentation, our HPLC systems and highly sensitive and selective detectors can help you perform reliable separations to ensure confidence in product quality as well as accurately determine and identify a wide variety of compounds with hard-to-detect analytes. Here are a couple of useful resources that can help you get up-to-speed in testing for authenticity of DS:
- On-demand webinar, titled, Characterizing Traditional Herbal Medicines and Herbal Supplements, (its the 5th webinar on the page; you can watch it after filling out a short registration form)
- Downloadable applications notebook, titled, Traditional Chinese Medicine HPLC Applications Notebook (you can download it after filling out a short registration form)
You might also be interested in checking out our Dietary Supplements and Nutraceutical Analysis community page for a wealth of information for your DS needs including downloadable application notes, on-demands webinars, white papers and more.
UPDATE: On February 09, the LCGC Magazine published an article (see below for title and link) which questioned why DNA barcoding technology was used instead of chromatography analysis. In the article, James Neal-Kababick of Flora Research Laboratories, an independent laboratory in the state of Oregon (USA) brings up some great points on why chromatography should have been used in the testing of the herbal products. He refers to the fact that the “U.S. Pharmacopeia and other standard-setting bodies around the world contain monographs for herbal products that indicate what tests should be used for identity testing. In most cases, the indicated methods include high performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC).”
The article, titled, NY Attorney General’s Analysis of “Fraudulent” Herbal Supplements Was Based on DNA Testing, Not Chromatography, presents a case for HPLC testing of herbal products.
I would like to hear of your dietary supplement testing challenges and if you have questions on the systems or looking for specific applications, do let me know using the Comments box below; I look forward to hearing from you.