Natural Foods Merchandiser

Final GMP ruling from FDA worth the wait?

The press releases and prepared statements started popping up online with the rapidity of a wildfire fanned by parched gusts of wind, with the laudatory comments and the quick condemnations so much smoke that you quickly lost sight of the forest. But the question still remains: Does the release of the final rule requiring current good manufacturing practices for dietary supplements plant the seeds for a strong, quality industry?

The answer from those hardy enough to read the 815-page tome is that it appears the U.S. Food and Drug Administration produced a solid document that spells out a reasonable process that will improve quality and safety for consumers. Of course, it only took the federal agency about a dozen years to complete after the Dietary Supplement Health and Education Act went into effect in 1994.

"Overall, I think it's a pretty balanced, fair regulation. I don't see too much in there that industry has to complain about," said FDA regulatory expert Marc Ullman, a partner with Ullman, Shapiro, Ullman law firm in New York.

Loren Israelsen, executive director of Salt Lake City-based United Natural Products Alliance, also gave the agency thumbs up after reading the whole regulation shortly after the FDA released it June 22. He said its negative tone had changed dramatically since the last draft in 2003, when FDA received about 400 comments from the dietary supplements industry and others.

"I think FDA has to be commended—not for speed in this case—for being pretty thorough," he said. "They really did go through all the comments. They really did respond to many of the comments, and they said why [they] agree or disagree."

The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and finished products. It also includes requirements for recordkeeping and handling consumer complaints.

The FDA says the rule will prevent supplements from containing the wrong type or amount of ingredients, and will prevent contamination by substances such as bacteria, pesticides, glass and heavy metals. The GMPs would also help ensure products are properly labeled and packaged.

"We're glad that they're out no matter how long it took," remarked David Seckman, executive director and chief executive for the Natural Products Association in Washington D.C. Other major industry trade organizations such as the Council for Responsible Nutrition made statements commending the FDA, while other groups like the American Herbal Products Association said it was still reviewing the document.

"It is too soon to know how well FDA incorporated the comments submitted by industry to the 2003 proposed rule, or to completely understand the economic implications of the final rule," said Michael McGuffin, AHPA president.

Most industry experts said they were initially surprised that the rule does not encompass raw ingredient suppliers. Israelsen said there are likely a couple of reasons for that omission. First, some suppliers provide ingredients to a number of industries, particularly food, and were probably concerned about having to meet two different GMP regulations. Second, many ingredient manufacturers are overseas, and while the dietary supplement GMPs do apply to foreign business, there's no practical way the FDA could inspect and audit those facilities. The burden of quality and identification of ingredients falls on the supplement manufacturers, Israelsen said.

"That becomes the real focal point," he explained. "A lot of time is spent in the preamble in FDA's comments about the importance of purchasers, that they know what they're buying. We agree with that as well. Where we end up: The emphasis will be on the manufacturer of the dietary supplement."

Of course, the bureaucratic machine runs on paper, and the final rules require heavy documentation, according to industry experts.

"If something's not in writing, it didn't happen" as far as FDA is concerned, Ullman said. "I think the regulations will bring this up to a whole other level of detail and analysis. I think it's significant ? you're required as part of your GMPs to have a written explanation, justifying what you're doing. People are going to have to know what they're doing and understand why they're doing it."

Companies will have to put procedures in place from top to bottom, according to Kathy Jordan, associate director of business development at Shuster Labs, a Canton, Mass.-based company that provides laboratory testing and quality assurance services to dietary supplement manufactures, among others.

"There has to be written procedures for just about everything," she said.

The regulation goes into effect Aug. 24, but has a three-year phase-in for small businesses. Companies with more than 500 employees must comply by June 2008, while companies with fewer than 500 people will have until June 2009. Companies with fewer than 20 employees have the full three years, until June 2010.

Jordan said size does not necessarily indicate how quickly a company may be ready to come into compliance. "There are small companies out there that have good quality assurance, quality control programs in place already, and implementing this rule will be no big deal," she said. "There are other small companies where this will be a stretch. They will probably have to put laboratories in their facilities or contract that service out."

Chris Scher, who juggles several responsibilities at Boulder, Colo.-based Kroeger Herb Products, including quality control, said his company will have to work hard to get up to speed with the GMPs. Kroeger employs about a dozen people.

"It's definitely going to be a challenge in some areas, but I think it's a good thing for the industry," he said. "It's going to help restore consumer confidence that gets battered around by positive and negative reports in the media."

One challenge that Kroeger faces is the requirement for 100 percent identity testing of all ingredients. Scher said the company uses many different materials and botanicals and there's not necessarily a scientific test readily available for each one.

"That's a biggie," he conceded, but added: "We've been preparing for this for the past 25 years, really. We've been trying to get ourselves in that position because we're a company that plans to stick around."

The regulation does have some wiggle room, according to Israelsen, when it comes to what scientific methods a company can use to verify identity, purity strength and composition of dietary supplements. "That's good news in that it gives a broader range of tools to work with. The challenge, however, is that you'll have the battle of the methods.

"We will now have to separate who is competent and capable and who is not," Israelsen added. "That is not easily done. A lot of companies are already following, or exceeding, these regulations. A number of companies have a lot of work to do."

The FDA also issued a companion document to the GMPs, an interim final rule that outlines how a manufacturer can request an exemption to the GMP requirement for 100 percent identity testing. The manufacturer can file for exemption if it can document how it can ensure purity with reduced testing.

"I think the regulation is going to put a lot of statisticians and consultants to work," Ullman observed.

Some consumer watchdog groups complain that while the GMPs may help assure quality manufacturing and prevent adulteration, they still don't guarantee that supplements are safe or effective. Ilene Heller, staff attorney for Center for Science in the Public Interest, said in a statement that SCPI welcomed the new rule but complained, "These regulations will not ensure that supplements are safe and effective."

Seckman said such views miss the point of what the GMPs are intended to accomplish. "The regulations were always meant to support procedures for the manufacturing of the products and the packaging and distribution, but it's not to deal with efficacy or safety. That's not the purpose of the rules. That's not what GMPs are for food or drugs or anything else."

If the FDA finds that supplements do not contain the ingredients they claim, the agency would consider the products adulterated or misbranded under the regulation. In minor cases, the agency could ask the manufacturer to remove an ingredient or revise its labels. In more extreme cases, it could seize the product, file a lawsuit or even seek criminal charges.

But, as most of the industry experts noted, the federal agency is still as understaffed as the day before the final rule was issued.

"They don't have the manpower," Israelsen agreed. "It's on us" to make sure the rules are enforced, he said.

There still appear to be quite a few questions to answer in the weeks and months ahead. But there seems to be a fresh breeze of optimism sweeping through the industry.

"Can you believe it? It actually came out?" Jordan mused. "It's here. So, whatever happened in the past is irrelevant. Now the industry can move forward."

The long road to respectability
Nearly 13 years have passed since the Dietary Supplement Health and Education Act put the dietary supplement industry on the road to respectability. The release of the final rule for current good manufacturing practices by the U.S. Food and Drug Administration in June appears to add a new dimension to the industry's rise to mainstream acceptability.

It's been a long road, and the final rule evolved as the world changed and the process to craft a regulation plodded on. Issues such as foreign suppliers and bio-terrorism were not concerns 10 years ago, noted Loren Israelsen, executive director of United Natural Products Alliance in Salt Lake City.

"It's really clear that some of the writing in there is very fresh," he said, noting specifically that that final rule says irradiation is no longer an acceptable method to remove microbiological bugs. "This is a major issue that hasn't yet been discussed, but certainly will be," he said of the stipulation banning irradiation.

Industry experts say the evolution of the rule also reflects the recognition that the dietary supplements industry is unique and really did require its own specific set of regulations.

"The reg went from initially being very food-GMP-like to becoming very drug-GMP-like and now becoming very Zen-like," Israelsen said. "That reflects a lot of pressures brought from outside forces, industry comments, and FDA's own internal uncertainty as to what do in this very fast, evolving world." The Zen-like element, he explained, is the agency's decision to allow flexibility in scientific methodology.

"They got the message from industry that there were really a lot of concerns," he said.

The understanding, in some ways, was years in the making:

  • 1994 — Congress passes the Dietary Supplement Health and Education Act.
  • 1997 — The FDA issued an advance notice of proposed rulemaking that contained current GMPs submitted by representatives of the dietary supplement industry as well as nine specific questions from FDA. Approximately 100 comments were received. These GMPs formed the basis of quality control used by many companies over the last decade in the absence of a formal rule, according to Kathy Jordan, associate director of business development at Shuster Labs, a Canton, Mass.-based company that provides laboratory testing and quality assurance services. Many companies, large and small, already meet or exceed the 2007 final rule requirements, she noted. "Oftentimes, our clients will ask for additional requirements as part of their audit," she said.
  • 1999 — FDA conducted numerous outreach activities to include public meetings to ascertain the best approach to rulemaking for dietary supplements.
  • 2003 — FDA issued a proposed rule to establish current GMPs for dietary supplements and dietary supplement ingredients. There were approximately 400 comments submitted in response to the proposal. The comments came from trade associations, government organizations and officials, health care professionals, consumer groups, manufacturers of dietary supplement and dietary ingredients, and individuals.
  • 2007 — The dietary supplement GMP final rule and interim final rule issued in June are based on the comments received and FDA's expertise, according to information on the FDA Web site. The interim final rule allows the manufacturer to petition the FDA for an exemption to the 100 percent testing requirement for the identity of dietary ingredients to be used in dietary supplements. The manufacturer would have to provide data demonstrating that less than 100 percent identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient.

This rule goes into effect Aug. 24. The compliance date is June 25, 2008 for businesses with more than 500 employees. Businesses employing fewer than 500 but 20 or more full-time employees would need to comply by June 25, 2009. Small companies under 20 full-time employees would have three years from the release of the GMPs, June 25, 2010. The 90-day comment period on the interim final rule for 100 percent identity testing ends Sept. 24.

—Peter Rejcek

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