Herbal Supplements are Under Fire (Again)

// Integrative Therapeutics

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A Recap of the Debate

Earlier this week, the New York State Attorney General issued cease-and-desist letters to GNC, Target, Walgreens and Walmart requiring them to pull store brand nutritional supplements from their shelves  (specifically herbals), based on the results of DNA testing. The products tested included Echinacea, garlic, ginkgo, ginseng, saw palmetto, St. John’s wort and valerian (the full press release can be found here). The cease-and-desist letters were issued as a result of allegedly finding that only 21% of the store-brand supplements contained DNA from the plant listed as the source on the label.

As the healthcare industry is aware, when mainstream tests such as this are performed and published, the validity of the methodology and the credentials of person(s) performing the test are always worth investigation. In this specific instance, DNA (barcode) testing was utilized, which for extracts, is an invalid testing method. Following this release, the scientific & nutrition community voiced their concerns:

“The AG’s study is not based on adequate science and its actions are thus premature. The use of DNA barcoding technology for testing of the identity of botanical dietary supplements is a useful but limited technology. DNA testing seldom is able to properly identify chemically complex herbal extracts as little or no DNA is extracted in many commercial extraction processes. Basing its actions on the basis of only one testing technology from only one laboratory, the NY AG results are preliminary and require further substantiation.”

– Stefan Gafner, PHD (Chief Science Officer & Technical Director) & Mark Blumenthal (Founder & Executive Director), American Botanical Council

“It is [now] clear that a majority of the products tested using DNA analysis are plant extracts, which do not inherently contain intact DNA from the plant material. This fact alone suggests that the majority of testing done is invalid. Working with our member companies, we will continue with our own internal testing of these products to determine whether we can confirm the results released by the New York attorney general’s office.”

– Loren Israelsen (President), United Natural Products Alliance
 

“These actions by the New York State Attorney General’s (AG) office smack of a self-serving publicity stunt under the guise of protecting public health. Supposed concerns about the products in question are based on a novel testing method that has been roundly criticized by botanical scientists who question whether DNA barcoding technology is an appropriate or validated test for determining the presence of herbal ingredients in finished botanical products. Processing during manufacturing of botanical supplements can remove or damage DNA; therefore while a DNA testing method can be useful in some cases, this method well may be the wrong test for these kinds of products.”

– Steve Mister (President & CEO), Council for Responsible Nutrition

Additionally, there is strong criticism surrounding the immediate cease-and-desist action, versus seeking additional expertise to complete further testing - an action that prompted both Target and Walmart to pull the products nationwide. This is reflected in the following statement by the Council for Responsible Nutrition:

“Instead of giving companies a reasonable opportunity to respond to these concerns, the AG unfortunately chose to label them guilty without a fair trial. Not only is the testing method itself suspect for these kinds of products, but the scientist who developed the assay and conducted the testing is not a botanical or a food expert. He is an evolutionary biologist who specializes in testing DNA in dinosaurs and lizards.”

Is the Consumer Reaction Justified?

Consumers have every right, and should feel empowered to ask the retailer, their health care provider and the supplement manufacturer, where the product came from, how it is made, and the testing that is done. You’ve seen the reaction already – the Twittersphere is being flooded with retweets of every major news outlet's coverage, others are skewing the original press release implying this is the case with MANY supplements. Facebook newsfeeds are filled with friends warning each other to stay away from these retailers entirely, and manufacturers are stepping up to defend their products.

Do consumers have the right to be concerned? Of course (given the information that’s been provided). This disclaimer is not meant to downplay the severity, however, based on the information that’s been released it’s clear that in this case, the testing is flawed, and more information is needed before the actions can be fully justified.


All Supplements are NOT Equal.

This is not a new concern for those of us in the industry. There certainly are manufacturers who don’t deliver what’s promised on the label. However, the truth of it is - there are many outstanding supplement manufacturers on the big box retailer shelves, and in practitioner offices as well as pharmacies. Perhaps the most unfortunate part of this story; is that there were no recommendations provided for consumers on how to identify what a high quality supplement looks like. The basics of which include:

  • NSF Certification
  • GMP (Good Manufacturing Practices): operating within a drug GMP audited facility
  • Testing that ensures safety and efficacy including:
    • Identity
    • Potency
    • Purity (free from contamination, including heavy metal and pesticide testing)
    • Bioavailability

Labels Will Never Be Enough.

Truth in labeling has received a lot of attention and action over the years - and rightfully so. However, there will always be limitations to what can be put on a product label. Often the words or logos and certification images don’t provide enough context for what it actually means. Consider the recent confusion and misuse of “natural”, “all-natural” and “100% natural” – terms that have been used for years on FDA approved products; or Jimmy Kimmel’s recent street interviews to see how many consumers know what a “gmo” product is.

Unfortunately, it’s not the full context of what labels can, and cannot, tell you about a product that gets the attention of mass media. It’s up to the consumer, to question, and look beyond the label. Consumers have every right, and should feel empowered to ask the retailer, their health care provider and the supplement manufacturer, where the product came from, how it’s made, and the testing that’s done.

Be a Part of the Solution

Our ask, to our customers, and all within the industry, is to continue in helping to disseminate accurate, unbiased information regarding labeling, and product quality. Not just in supplements, but for every single product that is brought into our homes.

(And in case you’re curious about our procedures –you can always find a detailed list of our quality assurance process & certifications here)



Updates

  • 2/6: FDA confirms that they agency does not use DNA barcode testing technology as a method for plant identification. Additional media channels reach out with speculation regarding the testing methods.
  • 2/7: In light of the report results not being released, United Natural Product Alliance (UNPA) has launched its own investigation to test the products through third-party labs, and to publicly share the results.
  • 2/9: GNC has released a response to the NY AG. Read the GNC statement
  • 2/12: A number of class action lawsuits against the four retailers have been filed in numerous states and the District of Columbia.
  • 2/13: The New York State Attorney General has now filed subpoenas demanding that the four retailers provide evidence to support the structure-function claims on their labels. Read more on this story

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