FDA Looks To Hone Supplement GMP Compliance With Sharper Focus For Inspections

FDA's supplement programs office is increasing its outreach to work with other agencies, states, the industry, health care professionals and consumer groups to improve oversight of the industry. The agency also expects GMP inspections to improve with officials focused on certain product categories.

Change is afoot in FDA's regulation of the dietary supplement industry, including a tighter focus on the product category by officials inspecting manufacturing facilities, even if funding for the agency's supplement programs is not changing.

The acting head of FDA's Office of Dietary Supplement Programs, Steven Tave, said on May 5 at the Council for Responsible Nutrition's Regulatory Summit that the office is increasing its outreach to other federal agencies, state officials, the industry, health care professionals and consumer groups to improve oversight of supplement manufacturing and marketing.

"Basically, if you have an interest in the regulation of dietary supplements, then we have an interest in working with you," said Tave, appointed in March as acting ODSP director, at the conference in Bethesda, Md.

Steven Tave, acting director FDA's Office of Dietary Supplement Programs

Image courtesy of FDA

The office has more leverage to engage with stakeholders in government and the private sector since it was upgraded in December from a division within the Office of Nutrition, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition (Also see "FDA Dietary Supplement Division Soon May Need Office Accommodations" - Pink Sheet, 7 Dec, 2015.).

"We're a layer above where we were before in the bureaucracy. That really makes a difference. We're a step closer to senior leadership both at the center level and the agency level. I can tell you from my personal experience, there is significant interest in the regulation of dietary supplements," Tave said.

"The bottom line is that dietary supplements have a higher profile at the FDA."

The profile boost, however, has not come with a resource boost.

Tave was frank in describing ODSP's challenge: FDA in total has around 15,000 full-time equivalents in staffing, with 22 assigned to the office, including Tave and three others currently in acting posts.

"So we really have 18 permanent employees in the office and we have a budget of about $5 million. Just to be clear, that's an m, not a b – $5 million," he said.

Meanwhile, the US industry has grown from around $4b in annual sales and about 2,000 facilities in the mid-1990s to currently around $40b in sales and 7,000 facilities "that we know of," Tave pointed out.

"When you think especially about the limited resources for the office, it's remarkable what we have been able to accomplish," he added.

One of ODSP's current focuses is accomplishing better compliance across the industry with the final rule for dietary supplement good manufacturing practices (Also see "GMP Documentation, Identity Testing Continue To Trip Supplement Firms" - Pink Sheet, 23 Mar, 2016.).

Tave said 30 warning letters for supplement GMP violations have been submitted in 2016 and inspections of manufacturing facilities, or sites where firms package, label and distribute finished products, are finding frequent violations "in very basic areas."

The areas include setting specifications for finished products and ingredients; determining whether those specs are met; producing and compiling master manufacturing and batch production records; and setting quality control procedures and assigning employees to specific roles for the procedures.

"These are fundamental elements of [current] GMPs and it’s just not acceptable," Tave said.

He noted that the final rule was published in 2007 and deadlines for complying with the regulations were phased in over three years depending on a firm's size. "They're not new. To be honest, the level of compliance that we're observing in inspections is just inadequate."

Room For Improvement On Inspections, Too

In addition to asking for better GMP compliance from supplement firms, FDA expects to improve its inspections of their facilities, says Latasha Robinson, chief of CFSAN's Labeling and Dietary Supplement Branch, which has responsibilities including implementing enforcement programs for supplements.

"By and large, we do a lot more dietary supplement work," Robinson said at the CRN event.

She said as FDA implements regulations established by the Food Safety Modernization Act, the agency will shift from assigning inspections of regulated companies based on regions where officials are stationed – Pacific, Central, East, Southeast or Southwest – to having staff inspect certain firms based on their expertise.

"We'll actually have dedicated cadres or groups that will be doing one commodity. They'll either be doing food inspections or drug inspection or device inspections. Our hope is that by restructuring, we have inspectors that have a ton of knowledge about one specific commodity, which in turn will drive the quality of inspections that they do as well as the quality of the work product they put out," Robinson said.

"We're hoping that it will drive a more commodity-specific knowledge, which will drive consistency and better inspections," she added.

While a timeframe for the inspection restructuring has not been set yet, a change to more consistency in FDA officials' inspections could not come soon enough for supplement firms.

Complaints about inconsistent work by FDA inspectors are common, said Greer Olsen Lautrup, a partner at Sidley Austin LLP in Washington. "It's just a fact and nothing's going to change," she said.

FDA officials differ in their inspection practices, including the areas of a firm's operations they may focus on, because they come to the job with different training, experiences and backgrounds. For instance, an official more knowledgeable and experienced in pharma site inspections likely will not do the same inspection of a supplement facility as another inspector who has predominantly worked in food industry oversight.

"They tend to bring that experience. So a food venue inspector is going to be looking a lot at sanitation, those sorts of issues. If you're unlucky enough to get a pharma inspector, they're used to the pharma environments and a lot different approach," Lautrup said.

"Despite the effort to make them all come together, they inherently are bringing the background that they come with."

Additionally, some inspectors arrive when expected, do orderly and efficient work and leave a facility at the end of a work day even if their inspection is not completed, Lautrup said. Others, though, show up unannounced, stay well past closing time and work in "complete chaos" while there, she said.

Nevertheless, complaining to FDA about an inspector will not change the findings that are made about a firm and its facility

"How do you respond to the inconsistency? My advice is to take the high road," Lautrup said.

"If you start whining, sniveling and criticizing the investigator, it's not going to be a winning proposition," she added.

Instead, firms should respond thoroughly on each observation FDA officials note on form 483s following inspections, explaining how each noted problem is being corrected or changed, and submit the information promptly to FDA. Following up with the agency later also is good practice.

Additionally, cooperating with FDA officials while they are inspecting facilities is likely to improve their impression of the firms.

"You don't want to get into a pitched battle. You could get this wrong and you could end up with a warning letter," Lautrup said.