The press releases and statements started popping up with the rapidity of a wildfire fanned by gusty wind, with the laudatory comments and quick condemnations generating so much smoke that it was easy to lose sight of the forest. But the question remains: Does the release of the final rule requiring good manufacturing processes 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 the U.S. Food and Drug Administration produced a solid document spelling out a reasonable process to improve quality and safety. It took the FDA about 12 years to complete the rule 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 the 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 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. The Council for Responsible Nutrition commended the FDA, while 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.
A raw deal?
Most industry experts said they were initially surprised that the rule does not encompass raw ingredient suppliers. Israelsen outlined a couple of likely reasons for that omission. First, some suppliers also provide ingredients to the food industry, and were probably concerned about having to meet two different GMP regulations. Second, many ingredient manu?facturers 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," Israelsen 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."
The paper mill
Of course, the bureaucratic machine runs on paper, and the final rule requires 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 supplements manufactures, among others.
"There has to be written procedures for just about everything," she said.
Pressed for time
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, including quality control, at Boulder, Colo.-based Kroeger Herb Products, 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.
Room for maneuvering
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," he said.
"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.
The rule's reach
At least one consumer watchdog group complained that the GMPs don't go far enough. Ilene Heller, staff attorney for the Center for Science in the Public Interest, said in a statement that CSPI welcomed the new rule but added, "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."
Enforcement will be an issue, Israelsen said. The FDA is already stretched beyond its ability to monitor the industries under its purview.
"They don't have the manpower," Israelsen explained. "It's on us" to make sure the rules are enforced, he said.
Natural Foods Merchandiser volume XXVIII/number 8/p. 1, 11, 14