Senators Ask Why GMP Compliance Eludes Dietary Supplement Firms

Democrats Durbin and Blumenthal raise concerns about the “pervasiveness of poor manufacturing standards” in the supplement industry and demand to know what trade groups will do to improve compliance with good manufacturing practices.

Sens. Dick Durbin and Richard Blumenthal demand answers from dietary supplement industry trade groups about supplement firms’ widespread struggles to comply with good manufacturing practices.

In July 6 letters, the two Democrats ask the Council for Responsible Nutrition and the Natural Products Association what they are doing to ensure companies that manufacture, package, label and distribute dietary supplements marketed in the U.S. comply with the 2007 GMP final rule.

“We are deeply concerned about the pervasiveness of poor manufacturing standards that expose consumers to potentially serious health risks due to dietary supplements containing ingredients in amounts greater or less than those listed on the label, unintended or undisclosed ingredients and contamination by bacteria or lead,” the senators wrote.

FDA’s recent warning letters about supplement firms’ GMP violations, as well as the dozens of warning letters the agency has submitted since enforcement of the final rule began, reflect the senators’ concerns (Also see "FDA Letters Show Basic GMP Violations Still Plague Supplement Firms" - Pink Sheet, 16 Jul, 2012.).

In addition, the agency will pursue court orders to shut down supplement manufacturers that fail to respond to warning letters identifying GMP violations. These actions include a compliant the Department of Justice filed July 13 in the U.S. District Court for the Eastern District of New York seeking an injunction requiring Kabco Pharmaceuticals Inc., to stop producing and distributing supplements until Kabco complies with the GMP requirements. The of Amityville, N.Y., firm’s supplements include Night-Time Herb Capsules, Inositol Calcium & Magnesium Capsules, Vitamin C-500 with Rose Hips Time Released Tablets and Joint All Capsules.

Dara Corrigan, associate commissioner for regulatory affairs, said in a release that FDA works with firms to ensure their processes comply with FDA’s regulations. “But when a firm refuses to comply, we will take aggressive enforcement action,” Corrigan said.

“We are eager to hear of the industry’s plans for improving the successful adoption of [GMPs] by companies” in the supplement manufacturing space.

– Sens. Durbin and Blumenthal

Durbin, a longtime supplement industry critic from Illinois, and Blumenthal, elected to the Senate in 2010 after high-profile service as Connecticut’s attorney general, complained that even though GMP standards were finalized in 2007, “FDA inspections show that half of the firms are falling short and almost 25% have committed serious offenses that warranted letters from FDA.”

They added “many of the practices that have been cited as failing to comply are basic, common sense safety practices that should not require regulatory guidance in the first place” (Also see "Supplement GMPs Stress Responsibility, Put Firms In Driver’s Seat For Testing" - Pink Sheet, 25 Jun, 2007.).

While the senators do not refer in the letters to plans for legislation that would impose tighter regulation of nutritional supplement manufacturing, they said they expect results from the industry. “We are eager to hear of the industry’s plans for improving the successful adoption of [GMPs] by companies” in the supplement manufacturing space, according to the letter.

The senators contacted the trade groups after The Chicago Tribune reported June 30 that FDA found GMP violations in half of the nearly 450 dietary supplement firms it inspected in the past four years.

An FDA official in October 2011 said the agency had ramped up inspections since all firms became subject to the final rule and was finding violations of fundamental GMPs (Also see "FDA Supplement Enforcement Priorities Go Beyond NDI Notification" - Pink Sheet, 31 Oct, 2011.).

FDA phased in industry’s GMP compliance deadline: June 2008 for large firms with at least 500 employees; a year later for mid-sized firms with 20 to 499 employees; and June 2010 for small firms with up to 19 employees (Also see "FDA's Reynolds Marks Top GMP Trouble Spots As Deadline Looms" - Pink Sheet, 10 May, 2010.).

CRN acknowledged in a July 11 letter to Durbin that “100 percent compliance by 100 percent of supplement companies” is ideal, but notes that the rule likely will “lead to a winnowing of the number of firms in the market” because not all will be able to comply. But, it also notes, the inspection results should be viewed in context.

For instance, CRN wrote, “even if ‘one in four’ of the firms inspected by FDA led to a GMP violation, one should not extrapolate that to the entire industry,” because FDA concentrates “inspections on those firms most likely to create a risk to public health, and most likely to yield violations of the regulations.”

“The firms it selects for inspections are not a random sampling of the entire supplement industry, nor are they representative of the many firms in full compliance with the GMP requirements,” CRN President and CEO Steve Mister added in the letter.

Basics Are Noted

Nonetheless, Durbin and Blumenthal noted the “violations include failure to meet basic manufacturing standards, such as verifying the identity of ingredients that go into products, inspecting batches of supplements and unsanitary conditions.”

“These manufacturing violations place consumers at risk and erode confidence that supplements have been manufactured to ensure quality,” the senators added.

In its response to the senators, CRN said, “Consumers deserve to know that, without question, their dietary supplement products are safe and made to high quality standards.”

That is why the trade group consistently pushed for GMP regulations between 1994, when the Dietary Supplement Health and Education Act passed and authorized FDA to prescribe GMPs for supplements, and June 2007, when the regulations were finalized, Mister wrote.

As soon as the rule was finalized, the trade group conducted a series of in-depth webinars and seminars. Most recently it co-hosted a June 12 webinar with FDA and industry representatives that discussed prevalent GMP violations and advised firms on how to identify and resolve frequent violations prior to an inspection and generally comply with the standards (Also see "FDA Will Take GMP Inspections To The Next Level" - Pink Sheet, 23 Jan, 2012.).

Mister noted CRN also led the creation of the Standardized Information on Dietary Ingredients protocol to improve communication between ingredient suppliers and finished product manufacturers. The SIDI work group is creating guidelines to help firms comply with GMPs and select and qualify vendors (Also see "Supplier Qualification Guideline Touts Flexibility, Defers Best Practices" - Pink Sheet, 23 Apr, 2012.).

NPA noted in a July 10 letter to Durbin that it also helped the industry by hosting the first GMP webinar after the final rule was released in 2007, and since has hosted multiple web-based and in-person seminars to educate the industry about the requirements.

NPA developed its own GMP standards for supplement firms and has revised the standards since the release of the GMP final rule to incorporate all the agency’s requirements. Its standard “actually exceeds the FDA’s GMP Rule in certain aspects,” according to the letter.

“NPA GMP Certification is awarded to companies that meet a high level of compliance to the NPA GMP standard as verified through comprehensive third-party inspections of facilities and GMP-related documentation,” it added.

The trade group plans to meet with both senators to further discuss what it has done and still can do to help firms comply, according to the letter NPA sent to Durbin and a separate same-day letter it sent to Blumenthal.

The American Herbal Products Association did not respond to a request for comment about the senators’ questions.

FDA Impatience Irks NPA

Like the senators, FDA appears increasingly impatient with the supplement industry’s poor compliance rate.

FDA Director of the Division of Dietary Supplement Programs Daniel Fabricant, as reported in the Tribune article, characterized inspection findings of basic violations as “downright scary.”

NPA complained in its letter to Durbin that “FDA’s reckless comments” in the article “distort the full picture of our membership’s overall safety record. In fact, supplements have an excellent safety record,” which the trade group plans to discuss further with the senator.

“We were surprised about the commentary given by the FDA to the Chicago Tribune last week, especially considering our strong ongoing relationship with the FDA to address related concerns,” NPA Executive Director and CEO John Shaw said in a July 10 statement.

“It is important to emphasize that dietary supplements are part of a fully regulated industry and good manufacturing practices apply to all supplement manufacturers large or small,” Shaw added.

This is not the first time Center for Food Safety and Applied Nutrition officials have taken the industry to task for failure to meet basic requirements, though. Fabricant and another DDSP official told supplement firms in January during a CRN webinar that many firms still must master the basics, and that the most frequently cited problems include incomplete master manufacturing records, batch record deviations, incorrectly handled raw materials, inappropriate reliance on certificates of analysis and quality control issues (Also see "FDA Will Take GMP Inspections To The Next Level" - Pink Sheet, 23 Jan, 2012.).