Following criticism from supplement experts that DNA testing methods used to justify cease-and-desist letters sent to four major U.S. retailers of herbal products on Feb. 2 were flawed and invalid, the New York Attorney General has now issued subpoenas requesting substantiation of label claims.
 
“There are already federal laws and statutes in place to require dietary supplement firms to only make claims that are truthful and not misleading,” said Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA). Statutes also stipulate firms must “obtain competent and reliable scientific evidence for claim substantiation; and file a 30-day structure/function notification for each claim that they make for dietary supplement products.”
 
Dr. Fabricant said New York Attorney General Eric Schneiderman should be inquiring about this information with FDA, as the agency should already have the information at hand.
 
“Moreover, the products being investigated by the attorney general contain some of the most widely researched ingredients in the industry. Ingredients such as St. John’s Wort, Ginkgo biloba, ginseng and Echinacea have droves of scientific research behind them, which is readily available on ClinicalTrials.gov. The multiple clinical studies on these types of products support and substantiate the physical benefits of these ingredients made in structure/function claims.
 
Dr. Fabricant went on to say that if Mr. Schneiderman were properly informed, he might have pursued companies making egregious weight-loss claims or targeted ingredients that aren’t backed by science, as the Federal Trade Commission has done.
 
“Since the attorney general appears to be more focused on making headlines than actually protecting consumers, he foolishly went after ingredients with hundreds of clinical studies behind them, substantiating the claims, an illogical and irresponsible tactic for law enforcement.”
 
The NPA considers the attorney general’s action “yet another form of harassment against an industry that serves hundreds of millions of Americans safely and effectively each day,” Dr. Fabricant added.
 
“The attorney general is using these subpoenas as a misdirection, removing focus from the fact that he still has yet to release the data from the DNA study he used as the basis for his original cease-and-desist.”
 
Industry members have continued to call for transparency, requesting the attorney general release study data. “It is imperative that Attorney General Schneiderman provide the details of his data, including the reference material library, before this issue morphs into yet a different angle and moving target in his attempt to castigate the entire industry,” Dr. Fabricant said.
 
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), expressed confidence that the companies subpoenaed will be able to provide the substantiation to support the label claims on their products. “Federal law already requires that any claims made by manufacturers or marketers of dietary supplements have substantiation to support those claims.”
 
The law requires dietary supplements have “competent and reliable scientific evidence” to support structure/function claims, he added.
 
“Under the law, dietary supplements cannot be sold with labeling that claims to treat, cure, prevent or mitigate a disease, and FDA has full authority to take action against companies that misbrand dietary supplements or make false or misleading claims. In addition, the manufacturing of dietary supplements is regulated by Good Manufacturing Practices regulations, enforced by the FDA. Similarly, the advertising for dietary supplements must be truthful, not misleading and substantiated with credible and reliable scientific evidence, enforced by the Federal Trade Commission.”
 
The attorney general’s investigation has sparked the filing of several class-action lawsuits around the country and set off a wave of negative media attention for the industry.
 
Education & Damage Control
CRN has assembled a microsite for consumers to keep them informed on important issues and how the association is responding to the issue: http://www.crnusa.org/NYAG/
 
In their call for transparency, experts have criticized the attorney general’s testing protocol, saying DNA barcoding analysis is not a validated testing method for identification of herbal extracts.
 
The non-profit American Herbal Pharmacopoeia (AHP) sent Mr. Schneiderman 58 pages of scientific and technical data, covering widely recognized, standard testing methodologies.
 
The dossier included national and international monographs for each of the seven herbal dietary supplements recently tested for the New York AG, highlighting the appropriate characteristics of each plant and extract. The communication acknowledged that adulteration of those products may exist in the marketplace but that the analytical technology used by Clarkson University for the AG likely did not accurately and adequately prove this.
 
The letter, signed by AHP Executive Director Roy Upton, stated in part, “With rare exception, DNA barcoding is not an appropriate technology for testing the identity of ingredients in extracts. By definition, extracts are made by extracting the desired constituents from the plant material itself into a liquid medium, a process that either does not maintain the DNA or significantly denatures it. The extract is then processed and dried onto an appropriate carrier. In that process, an extract is sometimes subjected to heating or further mechanical filtering, which similarly either removes or further denatures DNA if present. With most extracts there is no actual plant tissue left or, if any material remains, it can be greatly degraded. Because of this, there is either no DNA in finished products, such as those tested, or there is too little intact DNA to get an accurate finding.”
 
Meanwhile, education efforts are also taking place throughout the supply chain. For example, in a letter to its customers, Jiaherb Inc, a large botanical ingredient manufacturer based in China, also stated that DNA testing may offer misleading results.
 
“As we know, there are many processes involved in the production of botanical extracts. These processes include but are not limited to: milling, blending, high temperature extraction methods, solvent extraction, concentration, and purification. All these can result in the removal or damage of the botanical ingredients DNA. With that being said, it is expected that DNA results will be negative after undergoing such an extensive production process. Jiaherb believes that in order to accurately identify a botanical ingredient in a dietary supplement, one should use test methods such as HPTLC and HPLC rather then DNA technology.”