Rep. Urges FDA to Stop Illegal NDI Copycats

Texas Rep. Steve Stockman urged FDA to take enforcement action against companies that illegally piggy back on other companies' new dietary ingredient (NDI) notifications.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires companies submit NDI notifications to FDA 75 days before going to market in the United States. NDIs are not required when an ingredient is chemically identical to one that's already been introduced to the market, but Stockman said some companies are introducing new ingredients without notification.

"Those companies that sell these products that have submitted NDI notifications are taking positive action to ensure consumer safety, while those companies which skirt FDA requirements for NDI notification are putting consumers at risk by offering illegal versions of supplements whose ingredients have not be properly vetted by the FDA," Stockman wrote in a letter to FDA commissioner Dr. Margaret Hamburg.

Calling out three ingredients in particular, Stockman said multiple Chinese companies have introduced NDIs to the U.S. market without FDA notification. The three "reputable multinational corporations" Stockman said have been harmed by illegal competitive ingredients are Mitsubishi Gas Chemical (pyrroloquinoline [PQQ]),  Fuji Health Sciences (astaxanthin) and Xsto, which is the exclusive distributor for Hamari Chemical (zinc carnasine), according to Marc Ullman, partner, Ullman, Shapiro and Ullman.

"As the letter says, we don't know the conditions under which the ingredients are made, we don't know if the people who are producing these ingredients know what they are doing, we don't know if they are able to consistently produce the same thing, and there's no assurance of control in the manufacturing process, and that creates a public health risk," said Ullman, who represents Mitsubishi, Fuji and Hamari. "It also creates a terribly unfair competitive situation."

While industry has asked FDA to address exactly what kind of chemical alterations would require a NDI notification, Ullman said the practice of "me too" products hasn't been address by FDA. "And this is a problem," he said.  "Fuji, Hamari and Mitsubishi invested a lot of money into developing a proprietary manufacturing processes, doing safety studies and going through the NDI notification process."

In contrast, Ullman said the copycat companies did not invest as much, and they are selling their products at a much cheaper price. These companies don't have anything that shows safety data, Ullman said.

Ullman said he expects other companies and government officials to support Stockman's letter. " We are fairly certain that there are a large number of companies that are devoted to science and compliance that would welcome our efforts," he said. Ullman added a variety of other representatives in Congress and the Senate that have expressed interest in this matter; he said he hopes more will sign off on the letter.

If a company with an NDI faces a similar situation with competitors illegally entering the market, Ullman suggested they petition FDA for enforcement. His advice for FDA: "Stop it at the border if there's no NDI. Most of the offending material is imported. Don't let it into the country."