Pharmachem Gains Phase 2 Claims Agreement, Plus Patent For New Product

Pharmachem Laboratories' experience with claims for its Phase 2 starch-neutralizer branded ingredient may provide an example for firms seeking to validate claims with the FDA, the firm says.

As Pharmachem applied for a patent for ingredients in a new version of Phase 2, it learned FDA objected to structure/function claims made by consumer product companies using its ingredient.

Two years later, Kearny, N.J.-based Pharmachem has a patent, and FDA has no objections to Phase 2 structure/function claims slightly altered from language the agency previously shot down.

The U.S. Patent and Trademark Office awarded the patent in May 2006, Mitchell Skop, Pharmachem's sales and marketing director, said.

The patent combines Phase 2 with food-bound minerals, chromium and vanadium, to "handle glucose metabolisms from three different mechanisms," Skop explained.

Pharmachem launched its new product, Phase 2 CR, made with the chromium-bound mineral, after FDA stopped questioning its structure/function claim.

"We're actually using this good news as a platform to launch a new patented version of Phase 2. We're inviting brand owners and their retailers to begin to use the new Phase 2, to begin to use the new claims and to put them back on the shelves for consumers eventually," Skop said.

"We never released it," he added. "We were waiting for the right moment and this seems to be a good time for that."

FDA in November 2004 submitted a warning to Pharmachem, saying claims on labeling for Phase 2 "are false and misleading." Claims including the product's weight-loss effects and its neutralization of dietary starch absorption "are not supported by competent and reliable scientific evidence," according to the warning letter (¹ (Also see "Carb-Blocking Supplement Marketers Served With FDA Warning Letters" - Pink Sheet, 8 Nov, 2004.), p. 15).

However, in November 2006, following its review of information Pharmachem provided to substantiate the claims, FDA said it did "not object to" the firm's proposal for statements its customers can use to describe the weight-control and starch-digestion properties of their products made with Phase 2.

FDA "basically bought the two claims," but advised that the company put the word "may" in front of them and change "weight loss" to "weight control," said Charles Raubicheck, the attorney representing Pharmachem.

Substantiating the claims did not come without Pharmachem investing time and research. The company contacted FDA soon after receiving the warning letter, but a meeting with agency officials did not come until January 2006.

"This shows other brand owners that if they study their ingredients, they can collaborate and cooperate with the agency and benefit tremendously like we are," Skop said.

The firm submitted "60 pounds or so of original scientific data on our specific ingredient and we did it in about a week or two" after receiving the 2004 warning, he added.

Because Pharmachem sells to manufacturers which use its ingredients for consumer products, and does not provide retail products, the claims FDA cited were made by some of its customers, Skop said.

The claims were withdrawn by companies using Phase 2 during the FDA review, but Pharmachem continued providing the product as it discussed acceptable claim language with the agency.

Pharmachem - assisted by researchers Harry Preuss, M.D., of the Georgetown University Medical Center, Washington, D.C., and Joe Vinson, Ph.D., of the University of Scranton, Pa. - provided data to FDA showing Phase 2 ingredient claims were substantiated, said Raubicheck, of Frommer, Lawrence & Haug LLP in New York.

"Essentially we were unique in making the claim that weight loss was due to the inhibition of starch digestion, which is a unique property of Phase 2," he added.

The product's function is enabled by the ingredient Phaseolus valgarus, an extract from white kidney beans. Proprietary to Pharmachem is its process for isolating, purifying and standardizing the extract, Raubicheck said.

- Malcolm Spicer ([email protected])