Supplement industry to test botanical products at heart of NY AG Probe

As New York Attorney General Eric Schneiderman continues to investigate whether national retailers marketed fraudulent supplements that failed to contain such botanicals as Ginkgo biloba and St. John’s wort, an organization with long-term ties to the industry is collecting samples of the same products in order to have them tested by a handful of third-party laboratories.

The United Natural Products Alliance (UNPA) has launched its own investigation to test the products through third-party labs, then publicly share the results.

The lab results could either validate Schneiderman’s findings, entirely contradict them or produce mixed findings that are unlikely to placate either New York authorities or an industry that is still reeling from the investigation.

The ongoing probe, first reported in the New York Times, has fueled a crisis in the dietary supplement industry after Schneiderman’s investigation divulged through DNA testing that the botanical supplements were tainted with contaminants and mostly failed to contain the labeled botanicals.

The Attorney General’s office, herbal science experts and supplement trade organizations contend, relied on a DNA testing methodology that is not well suited for identifying products that contain botanical extracts because DNA may have been destroyed or degraded during the extraction process due to the use of solvents and for other reasons.

One of the retailers—General Nutrition Corporation (GNC)—informed the Natural Products Association (NPA) that all its products identified in Schneiderman’s probe were botanical extracts, said Daniel Fabricant, executive director and CEO of the trade organization, in a phone interview. GNC on Friday confirmed that is accurate.

A Clarkson University biology professor retained by New York authorities used DNA barcoding to test the ingredients in the products. Schneiderman’s office described the technology as “short genetic markers in an organism’s DNA" that “provide an unbiased, reproducible method of species identification."

Botanical experts acknowledge DNA testing is a promising technology in the field, but it’s relatively novel and isn’t used by the federal health agency that oversees dietary supplements.

Although FDA is striving to develop methods to identify plants, DNA sequencing is not a technology FDA presently uses to verify ingredients in supplements, said Siobhan DeLancey, an agency spokeswoman.

“FDA has been working on building a plant species DNA library sequences for plants, but this project is not complete," she said in an emailed statement. “We currently use chemical markers or fingerprints for ingredient verification."

NPA and others have pressed the Attorney General’s Office to share the data from its DNA barcoding lab results. So far, that hasn’t happened.

“Rather than attacking testing methods that have been validated by more than 70 published papers, the time has come for the herbal supplements industry to put concerns about what is and is not included in their products to rest," the Attorney General’s Office said in an emailed statement. “The fact is virtually every product we tested includes ingredients not listed on the packaging, and close to 80 percent failed to show any evidence that they included even trace amounts of what was advertised. This is ultimately a matter of public health, and when public health is at stake, the burden is on this largely unregulated industry to prove what's in its products."

The industry may be heeding that call to action. A Utah-based organization with ties to the industry dating back to the 1990s is taking matters into its own hands.

Loren Israelsen, the president of UNPA, said members of his organization have purchased the same botanical supplements identified in the Attorney General’s investigation from GNC, Walmart and Target at stores around the country.  

The products are sitting under quarantine at UNPA’s facility in Salt Lake City. Frank Lampe, UNPA’s vice president of communications and industry relations, said the organization anticipates obtaining samples from at least 25 stores from each of the three chains.

UNPA plans to ship the products to a handful of laboratories around the country for testing, then later publicize the lab results after an expert panel analyzes them.

In letters dated Feb. 2, Schneiderman’s office demanded that the four national retailers remove the products from the market and furnish data, including the names of the manufacturers and the analytic testing that was performed on the herbal supplements.

The retailers have capitulated, temporarily removing the botanical supplements from New York stores, but stand behind their testing.

“The products in question have been tested using scientifically validated, widely used methods approved by governing bodies like the FDA-recognized United States Pharmacopeia and are fully compliant, safe, and properly labeled," Walmart spokesman Brian Nick said Friday in an emailed statement.

Israelsen said he first learned about the probe after a colleague called him at his office and asked if he was sitting down.

The results were astonishing and plastered on the front page of the New York Times. Of the herbal supplements tested at four national retailers, only 21% of the results verified DNA from the plants matched the labels, according to New York authorities. Seventy nine percent of results disclosed there was no DNA matching the labeled content, or the tests confirmed contamination with other plant material, the Attorney General’s Office said.

“Our first reaction was that the test results were so uncharacteristic of what we would expect and because they only used the DNA barcode testing, we felt it was important and urgent to secure samples of the same lot numbers of products in order to be able to test those lots with highly regarded, highly competent laboratories with deep expertise in these class of products," Israelsen said in a phone interview Thursday. “We issued a call to our members to fan out with the list of the products noted in the AG’s release, to purchase and forward to us those products on the view they may disappear off the shelf quickly and that the ‘evidence’ would disappear."

UNPA cannot immediately confirm whether the products in Salt Lake City match the lot numbers identified in the Attorney General’s cease-and-desist letters.

“It is our hope that we have a very high percentage of lot matches and we’ll use that as our primary test group of samples," Israelsen said. “Plan B, if there are other lot numbers of the same products, we will go ahead and test those."

Israelsen said the organization is devoted to maintaining a clean chain-of-custody and ensuring the testing is conducted by independent labs. He said the products are unopened and still in the original shipping containers.

“The answer to bad science is good science," Israelsen said. “We believe the AG’s office erred by using a very interesting scientific technology that was inappropriate for this purpose. We don’t know if they did that out of ignorance or on purpose. But the question on the table is, are those results legitimate? This exercise is to answer that question."

“It is not our objective," he added, “to influence what the outcome is."

The testing is likely to exclude products that were sold by one of the four national retailers: Walgreens. Israelsen said members were unable to purchase the relevant botanical supplements from the retailer because when they took the products up to the counters, the clerks were notified through Walgreens’ system not to sell them.

James Graham, a spokesman for Walgreen Co., said the retailer removed products from the shelves outside New York in response to the Attorney General’s letter, which specified, “kindly remove all of the supplements identified below which may bear the lot number indicated no matter the store location." 

UNPA has not asked Walgreens for the products, and it’s not likely to get them. “Our attorneys advise me that we cannot release samples for third-party testing at this time," Graham said, after our publication advised him of UNPA’s plans.