Reading Between the Lines
10.01.07
In mid-September, I attended a good manufacturing practice (GMP) seminar organized by the United Natural Products Alliance (UNPA), Salt Lake City, UT. Not only did this seminar offer a comprehensive overview of the regulations, but it also put them into context, relating the real world implications of the rule to the audience and laying out what companies can expect in the months and years ahead. While the GMPs themselves are fairly straightforward, UNPA executive director Loren Israelsen said it is the 815-page preamble to the GMPs that provides deeper insight into FDA's and OMB's thinking and rationale with respect to the requirements-it also leaves some significant questions. Mr. Israelsen encouraged all, no matter what your role in the supply chain, to pay close attention to all of the issues raised in this particular section, even if it means taking it one line at a time.
The pace at which changes occur within the industry, said Mr. Israelsen, will not necessarily be dictated by new laws and regulations specific to dietary supplements, but rather recent events surrounding food safety and bioterrorism. The new GMPs reflect how dietary supplements are perceived and regulated in the new era of globalization, especially considering that roughly 70% of dietary ingredients come from outside the U.S.
The dietary supplement industry is comprised of 774 companies, 53% of which are considered "very small"-or having less than 20 employees. The bad news is the new GMP rules will probably push a lot of these smaller players out of business. For others, the new regulations will spark joint ventures, partnerships or acquisitions throughout the supply chain. Considering this, Mr. Israelsen asked: "Will companies decide to sue FDA for violating small business economic standards? This may not be a small company game much longer."
Also receiving lot of attention lately is the conspicuous absence of ingredient suppliers from the final regulation. FDA is very vague about this aspect, saying only that while suppliers may be "affected" by the rule, they will not be "subjected" to it. Mr. Israelsen said this decision probably stemmed from complaints made by conventional food companies, which do not want to be governed by two separate GMP rules. He also said early media reports and comments from critics specifically pointed to the melamine scandal as the reason suppliers need to be subjected to the rule. It seems the role of the supplier and the standards to which they are held will continue to be hotly debated.
While the GMP burden rests with finished product manufactures, suppliers of dietary ingredients will have their own set of issues to contend with. For example, suppliers will have to demonstrate some level of GMP compliance in order to work with dietary supplement manufacturers. This will most likely prompt suppliers to seek third party GMP certification-indeed this is already a major trend. Further, there will be more reliance on and scrutiny of certificates of analysis (CofAs) for ingredients. Presently, Mr. Israelsen says there is very little confidence in CofAs in the market, a situation that must improve in the near future. "Everything will revolve around confirming the identity of material," he said, and proving the authenticity of CofAs will be a future sticking point.
Perhaps one of the most interesting things Mr. Israelsen brought up was FDA's definition of quality, which is: a dietary supplement manufactured to a standard on a consistent basis. Unfortunately, FDA does not define the "standards" to which these products should be manufactured. Instead, it is up to a company to decide to which standards it will manufacture its products. The problem is a company could choose to establish the lowest standards possible, but as long as it meets those standards consistently, it will still be considered GMP compliant.
Establishing and documenting procedures will also be an important part of the new GMP game. In fact, this is probably where the largest costs are likely to occur. Record-keeping will also be crucial, especially when FDA shows up at your door unannounced to conduct an audit. Companies should be prepared at ALL times because this is an area where they are most likely to get busted, according to Mr. Israelsen.
There was so much ground covered in the UNPA GMP seminar and the space of my editorial doesn't do it justice. But many more issues will be discussed in the coming months throughout the pages of Nutraceuticals World, especially with regard to contamination, adulteration, analytical testing and much more. Stay tuned!
Rebecca Wright
Editor
rwright@rodpub.com
The pace at which changes occur within the industry, said Mr. Israelsen, will not necessarily be dictated by new laws and regulations specific to dietary supplements, but rather recent events surrounding food safety and bioterrorism. The new GMPs reflect how dietary supplements are perceived and regulated in the new era of globalization, especially considering that roughly 70% of dietary ingredients come from outside the U.S.
The dietary supplement industry is comprised of 774 companies, 53% of which are considered "very small"-or having less than 20 employees. The bad news is the new GMP rules will probably push a lot of these smaller players out of business. For others, the new regulations will spark joint ventures, partnerships or acquisitions throughout the supply chain. Considering this, Mr. Israelsen asked: "Will companies decide to sue FDA for violating small business economic standards? This may not be a small company game much longer."
Also receiving lot of attention lately is the conspicuous absence of ingredient suppliers from the final regulation. FDA is very vague about this aspect, saying only that while suppliers may be "affected" by the rule, they will not be "subjected" to it. Mr. Israelsen said this decision probably stemmed from complaints made by conventional food companies, which do not want to be governed by two separate GMP rules. He also said early media reports and comments from critics specifically pointed to the melamine scandal as the reason suppliers need to be subjected to the rule. It seems the role of the supplier and the standards to which they are held will continue to be hotly debated.
While the GMP burden rests with finished product manufactures, suppliers of dietary ingredients will have their own set of issues to contend with. For example, suppliers will have to demonstrate some level of GMP compliance in order to work with dietary supplement manufacturers. This will most likely prompt suppliers to seek third party GMP certification-indeed this is already a major trend. Further, there will be more reliance on and scrutiny of certificates of analysis (CofAs) for ingredients. Presently, Mr. Israelsen says there is very little confidence in CofAs in the market, a situation that must improve in the near future. "Everything will revolve around confirming the identity of material," he said, and proving the authenticity of CofAs will be a future sticking point.
Perhaps one of the most interesting things Mr. Israelsen brought up was FDA's definition of quality, which is: a dietary supplement manufactured to a standard on a consistent basis. Unfortunately, FDA does not define the "standards" to which these products should be manufactured. Instead, it is up to a company to decide to which standards it will manufacture its products. The problem is a company could choose to establish the lowest standards possible, but as long as it meets those standards consistently, it will still be considered GMP compliant.
Establishing and documenting procedures will also be an important part of the new GMP game. In fact, this is probably where the largest costs are likely to occur. Record-keeping will also be crucial, especially when FDA shows up at your door unannounced to conduct an audit. Companies should be prepared at ALL times because this is an area where they are most likely to get busted, according to Mr. Israelsen.
There was so much ground covered in the UNPA GMP seminar and the space of my editorial doesn't do it justice. But many more issues will be discussed in the coming months throughout the pages of Nutraceuticals World, especially with regard to contamination, adulteration, analytical testing and much more. Stay tuned!
Rebecca Wright
Editor
rwright@rodpub.com
