United States: Purity Or Purely Political: New York AG’s Dietary Supplement Science Fiction Feeding A Class Action Frenzy

Last Updated: February 9 2015
Article by Michael A. Walsh and Katherine McGahey

Buyer Beware or Seller Beware?

"This investigation makes one thing abundantly clear: the old adage 'buyer beware' may be especially true for consumers of herbal supplements," said Attorney General Schneiderman in his February 3, 2015, press release. This is followed by endorsements from New York State Senator Ken LaValle, who has sponsored legislation to establish a "dietary supplement safety committee," and New York State Assembly member Felix Ortiz, who has been pushing for legislation for ten years. The reality is what we regularly counsel: manufacturers and sellers of dietary supplements beware, because the regulators don't like you.

The NY AG's Predetermined Conclusion in Search of Scientific Proof

The NY AG press release is referring to a purported study undertaken by his office to investigate the "purity" of select herbal supplements that resulted in cease and desist letters being issued to four major retailers. This, of course, led to attention grabbing headlines and news reports across all major media channels. And consumers may "beware" as politicians use questionable scientific evidence to advance a political agenda not a public health agenda. And the government's new weapon of choice is questionable—or, more accurately, immature—science, at best. But, when anyone says "DNA testing confirms ...," they usually don't have to say anything more to gain the confidence of the media and consuming public.

The industry response is centered around the NY AG using DNA barcoding technology. DNA barcodes are short DNA sequences from a standardized region of the genome, used to identify different species. This is done by comparing the barcode of a sample against a database of known barcodes. Use of the short sequence makes the testing faster and less expensive. The technique is highly effective in identifying many animal groups and has been used by the FDA, for example, to test seafood products.

For plant-based products, however, the DNA barcoding technology is not generally recognized as reliable. Scientists cannot use the same gene region as they use in animals because it evolves too slowly, and the database of plant species is incomplete. In addition, there is a significant difference between testing plants and plant-based products. Plant-based products, such as dietary supplements, often undergo processing that destroys the DNA in the raw materials. Dr. Pieter Cohen, Harvard Medical School assistant professor and expert on supplement safety, suggested the results of the NY AG test were so extreme as to be hard to accept, citing the issue that DNA destruction during processing would render the DNA barcode testing ineffective.

Herbal products may contain secondary metabolites and complex mixtures of organic chemicals that make accurate barcoding difficult. Further complicating the issue, supplement capsules are commonly made from plant- or animal-derived substances, such as microcrystalline cellulose or gelatin, which can contribute DNA to the test sample. The same is true for rice, starch, or any other organic compound added to a powder, for example, to prevent clumping. With current DNA barcoding technology, these could all show up as contaminants, fillers, or substitutions. These factors render DNA barcoding of an end-product supplement unreliable, at best.

Moreover, the research cited by the NY AG as the basis of his study of dietary supplements states "there are no standards for authentication of herbal products" and "no best practices in place for identifying the species of the various ingredients used in herbal products." Time will tell whether it was irresponsible for the NY AG to wield its police power in this way, electing to forego reliable testing methods for one not generally recognized to attack an entire industry. Other than serving political ends, this attack on dietary supplements benefits no one, especially not the tens of millions of Americans who rely on dietary supplements daily.

It is true that dietary supplements are not subject to the FDA's premarket review or approval requirements for safety and effectiveness. Nor are they subject to the rigorous manufacturing and testing standards that apply to drugs. But, reputable manufacturers and retailers have procedures in place to ensure that what they say is in their products, is in their products. Moreover, manufacturers are required by law to adhere to Good Manufacturing Practices (GMPs), which currently include validated scientific testing methods, from simple titration, to chromatography, to mass spectrometry.

Predictably, no sooner did the ink dry on the NY AG's press release than the class action lawyers began filing lawsuits. For the responsible and FDA compliant manufacturers and sellers of dietary supplements, irrespective of the merits of the NY AG or Class Action plaintiffs' claims, it is an expensive and time consuming road to travel to disprove unreliable science. But for the manufacturer and seller who itself is unsure whether the contents of the dietary supplements it sells match its labeling, periodic finished product lot testing may be something to add to the to-do list.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Authors
Michael A. Walsh
Katherine McGahey
 
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