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FDA sued over vague GMP rules; cancer-claim determination

The Alliance for Natural Health-US, along with three other plaintiffs, filed a total of three lawsuits against the U.S. Food and Drug Administration, claiming the FDA is violating the law by allowing agents to interpret and enforce unclear rules that could subject manufacturers to criminal penalties for minor violations, and suppressing health claims without proper review of supporting materials.

The ANH-US — along with dietary supplement formulators Durk Pearson and Sandy Shaw, and the Coalition to end FDA and FTC Censorship — is suing the FDA based on the administration's June 19 decision to "suppress claims that antioxidants reduce the risk of cancer," according to the ANH-US. On the same date, the FDA also denied a number of claims that selenium reduces the risk of cancer, which also resulted in a lawsuit filed in U.S. District Court in Washington, D.C.

Jonathan W. Emord, lead attorney in the action, said that in both cases, the FDA either reversed claims that it had earlier allowed, or allowed claims, but "saddled them with latent disclaimers that gave them a negative value."

In another lawsuit, the group claims the FDA is in breach of Fifth Amendment law governing vague, or unclear rules because the agency's Good Manufacturing Practices rules are difficult to understand and follow. Emord said manufacturers of dietary supplements don't know what to do to avoid violations. The rules are not specific and uniform and the FDA can make a determination as minor as a record keeping violation that can result in a manufacturer being shut down and even subject to felony prosecution, he said.

"Every instance is adulteration under the rule," Emord said. "It gives unbridled discretion to FDA enforcers to find parties guilty, whose products are fine. It's not what's reasonable under any definition of adulteration and it's not what Congress intended."

GMP rules are in place to protect public health. Inspections of facilities are conducted to prevent contamination of products. A spokesman for the FDA said the administration refrains from commenting on active lawsuits.

Emord said the selenium and antioxidant-related lawsuits seek declaratory and injunctive relief. The GMP suit is calling for a rewriting and clarification of the rules.

"I think what's most disconcerting in the selenium and antioxidants results is that free speech is being suppressed, so consumers are not being allowed to know what the health benefits are and they are not as educated in making decisions to take personal responsibility for their health," said ANH-US executive director Gretchen DuBeau. "With the GMP lawsuit, the concern is basically that the GMPs are written as such that the FDA is able to declare something adulterated as minor as a clerical error and it hurts the supplements industry."

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