CRN Tells Durbin FDA Used Distorted Stats

WASHINGTONThe Council for Responsible Nutrition (CRN) told Sen. Dick Durbin (D-IL) that FDA skewed statistics in a recent Chicago Tribune article that reported GMP noncompliance is widespread in the supplement industry. Steve Mister, CRN president and CEO, wrote on behalf of the organization also reminding the senator that it offers a number of educational resources to help supplement companies meet cGMPs (current good manufacturing practices).

Mister's letter was in response to a letter Sen. Dubin and Sen. Richard Blumenthal (D-CT) sent to CRN asking how it planned to improve GMP compliance. The senators wrote the letter following the Chicago Tribune article, which quoted Daniel Fabricant, Ph.D., head of the FDA's Division of Dietary Supplement Programs as calling the lack of compliance scary.

"Consumers deserve to know that, without question, their dietary supplement products are safe and made to high-quality standards," Mister wrote to Sen. Durbin. "We will continue to support FDA in its efforts to assure compliance with the cGMPs."

FDA's Stats in Context

While Mister said it will continue to work with FDA on GMPs, it said the information FDA provided the Chicago Tribune should be kept in context. Mister said the statistic one-forth of the firms inspected by FDA led to a warning letter does not apply to the entire industry. "Indeed, following FDAs own risk management principles for enforcement priorities, one would expect FDA to concentrate its inspections on those firms most likely to create a risk to public health, and most likely to yield violations of the regulations," Mister wrote. The firms FDA inspects are not random or representative of entire industry, he said.

Another statistic provide by FDA that half of the inspected firms had GMP violations are not correct, Mister said. Based on FDA data shared with the industry in June, Mister said this statement would be accurate only if one were to include notations for voluntary action indicated (VAI) . VAIs are issued for objectionable conditions observed during an inspection, but FDA doesn't make a recommendation because the conditions don't meet the threshold for regulatory action. With VAIs, firms voluntarily corrected the conditions during the inspection or promise immediate correction following completion of the inspection. "In other words" Mister wrote, "FDAs contention would only be close to accurate if these minor issues that do not even rise to the level of triggering regulatory action were included in the count."

FDA Enforcement

Mister said the goal should be 100-percent GMP compliance by 100 percent of supplement companies and urged FDA to use its enforcement powers. "It is incumbent on FDA and Congress to assign sufficient resources and priorities to the inspection of dietary supplement facilities to be sure the industry receives the message that FDA expects full compliance with the cGMP requirements and will accept nothing less."

CRN Resources

Mister also provided FDA with a list of educational resources it provides the supplement industry. He said CRN helped establish GMP regulations following the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). CRN worked with FDA to develop regulations that would help ensure safety and quality, he said. By the time of FDA implemented GMPs in 2007, many of CRNs members were already adhering to more stringent requirements, according to Mister.

Mister said CRN offers a series of in-depth webinars, in-person educational briefings, and seminars for both its member companies and non-member companies. For example, CRN recently partnered with VIRGO to conduct a webinar with participation by FDA officials that covered responding to a Form 483 violation notice, building a strong program for qualifying ingredient suppliers and choosing a contract laboratory.

In addition, Mister pointed out CRN led the formation of the Standardized Information on Dietary Ingredients (SIDI) protocol to enhance communication between ingredient suppliers and finished product manufacturers regarding the quality of ingredients. The SIDI Work Group developed a series of guidelines to aid the dietary supplement industrys compliance with the cGMPs with respect to the selection and qualification of vendors.