GSK Petition Met With Mixed Feelings at SupplySide West

On October 23, Sabinsa Corp. (Piscataway, NJ) hosted a meeting at SupplySide West to discuss a citizen’s petition that seeks to classify weight-loss claims on dietary supplements as disease claims. The petition was filed by the American Dietetic Association (Chicago), GlaxoSmithKline (GSK; London), the Obesity Society (Silver Spring, MD), and Shaping America’s Health (Alexandria, VA).

The four petitioners asked FDA in April to treat weight-loss claims as disease claims, because such statements “purport to prevent or treat an abnormal or unhealthy condition that, while not itself a disease, is a significant risk factor for disease.”

While many dismiss the petition as inconsequential, some attendees at the meeting asserted that the supplement community must be closer-knit in dealing with threats to the industry.

“The point of the meeting at SupplySide was to alert the industry to ways in which the supplement industry can be blocked in, in which case everyone’s affected,” supplement industry regulatory attorney Marc Ullman, one of the meeting’s speakers, said after the event.
The discussion, expected to draw some 130 people, according to Jeff Lind, CEO of Sabinsa, however, garnered about 30. Lind later said that he was disappointed in the “gross lack of industry support” in discussing the petition.

Speakers at the meeting included Michael McGuffin, president of the American Herbal Products Association (Silver Spring, MD); David Seckman, CEO of the Natural Products Association (Washington, DC.); Loren Israelsen, director of the Utah Natural Products Alliance (Salt Lake City); Steven Mister, executive director of the Council for Responsible Nutrition (Washington DC.), and Ullman.

“There is a long-standing problem in the supplement business with a few, select companies consistently expected to step up and challenge much larger problems,” said Ullman, who works with Sabinsa. He called for more “active support” within the industry.

Yet AHPA president McGuffin dismissed claims that supplement companies were not responsive to potential dangers to the market.

“This is not a bold call to industry,” he said. “I would not judge active support by numbers, mostly because companies rely on trade associations such as CRN and AHPA to act on their behalf. That’s why they become members. ”

According to the Council for Responsible Nutrition (CRN; Washington DC.), they feel FDA decided in 2000 that weight loss claims should be filed under DSHEA. They said that the intended use of many dietary supplements and other weight loss plans are for cosmetic reasons and immediate health benefits such as feeling better and having more energy, not primarily to manage their risk of disease.

Steve Mister, president of CRN commented, “Contrary to the petitioners’ assertions, if FDA were to grant this petition, it would result in sweeping implications for weight-related claims for the entire category of “food,” and create a slippery slope for other structure/function claims that would essentially ‘disease-ify’ many health conditions not currently considered to be diseases or surrogate endpoints for disease.”

“This would cripple the dietary supplement category as envisioned by Congress with the passage of DSHEA.”

McGuffin said most supplement companies know the petition will “most likely fail.”

A similar petition GSK filed in 2002 asked the administration to deny approval of any generic product containing ingredients used in its own antibiotic, Ceftin. The request was denied.
For this reason, the supplement industry seems to remain unruffled by the new petition.

“It’s an overreaction to amass the industry. There’s no need for an emergency press conference,” said McGuffin.