John Atwater, senior director of verification programs at USP, spoke with NutraIngredients-USA this week about the scope of the problem, one which threatens the trustworthiness of the entire industry. How big is the problem and is it getting worse?
“It’s difficult to determine the size the counterfeiting problem since by its nature it’s clandestine,” Atwater said. “Unfortunately no one has the answer to that question.”
Evidence of growing problem
But while the scope of the problem is hard to quantify, there is good evidence that it is getting worse. The situation is grave enough that in July online retailing giant Amazon took the unusual step of sending an email to site users saying that some products labeled as the Align brand of probiotics made by Procter & Gamble may have in fact been fakes. The company told consumers to dispose of the items.
Earlier in 2019 supplement manufacturer Nutramax Labs took matters into its own hands and didn’t wait for Amazon. It send a letter to customers saying a counterfeit version of one of its products had been for sale on third parter seller’s site on Amazon. The counterfeit P&G product was sold by a third-party seller, too.
And last year, The Atlantic magazine published a report detailing the many lawsuits that have been filed against Amazon alleging the company doesn’t do enough to police the veracity of the products in many categories including clothing and household goods as well as supplements sold on its site. According that article, the problem is accelerating.
“In 2007, U.S. Customs and Border Protection and U.S. Immigration and Customs Enforcement recorded 13,657 seizures of goods that violated intellectual property rights. Last year , the agencies recorded 34,143 seizures," the article stated.
Attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig, has said clients have brought cases of counterfeiting to his attention on numerous occasions. From his anecdotal evidence, the counterfeiters are getting better at their trade. A few years ago, when a client brought in a couple of bottles, the only way to tell the fake from the real stuff was that a color was slightly off on one of the labels.
In a more recent case Prochnow said the counterfeit was so well done there was no way to tell from the outside. Once the seals were broken, the orange color of the capsules was a tad bit different.
Sticking to verified products as bulwark against counterfeiters
Atwater said in his view the answer is simple. Have your products verified by a reputable third party, and, if you’re a consumer, stick to those products.
“People ask me all the time which products are good. I really have no way to know what to tell them, other than to tell them to stick to the products that have been USP Verified,” he said.
Atwater said the USP program sticks to what he called the ‘Four P’s,’ that is: positive ID, purity, potency and performance. By performance, USP means that capsules or tablets should dissolve as they should.
No one knows how many supplement products are on the market, but estimates range up to 80,000 or more. To date USP has about 100 products enrolled in the program, most of which bear NatureMade or Kirkland Signature (Costco) labels.
Not all products are candidates for verification
On the identity front, Atwater said for a product to qualify for the program, there must be validated methods for the identification of the ingredients. There are a number of methods in use, some of which might yield acceptable results but which would not pass USP muster, Atwater said.
And some products use ingredients that USP would not find acceptable, such as synthetic copies of naturally occurring botanical compounds. So not all products would quality for the program, which would limit its reach, he said.
“There are products out there that USP may not be able to verify,” he said.
And he said some products are in the program but their manufacturers prefer not to be listed on the USP website, he said. Or there could be other products that are in the process of being verified.
Atwater said USP’s emphasis on the quality of documentation backing the testing of the products and the GMP compliance of the facilities in which they’re manufactured sets his company’s program apart.
“Quality needs to be built into the product and not tested into the product,” he said.