[Congressional Record Volume 149, Number 120 (Thursday, September 4, 2003)]
[House]
[Page H7937]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                        PUBLICATION OF THE GMPs

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from New Jersey (Mr. Pallone) is recognized for 5 minutes.
  Mr. PALLONE. Mr. Speaker, I rise on the House floor this evening to 
express my appreciation for the publication of the proposed rule for 
dietary supplement current good manufacturing practices, or GMPs. After 
many years of delay and inquiry, I am pleased that the Food and Drug 
Administration finally put forth this proposed rule earlier this year 
as required by the Dietary Supplement Health and Education Act, also 
know as DSHEA. This is truly a step forward in health care and will 
help to ensure that the public has access to high-quality, safe dietary 
supplements.
  Overall, Mr. Speaker, I have found that the FDA's proposed rule works 
in favor of both consumers and the industry. The public should expect 
nothing less than safe and effective supplements, and it is encouraging 
to witness the government and industry joining together to provide 
consumers great confidence that supplements are free from 
contamination, accurately labeled and effective in improving personal 
health.
  The GMPs also provide guidelines that assist the dietary supplement 
industry in manufacturing safe, effective, unadulterated products. The 
industry fully appreciates the economic consequences of these proposed 
regulations and is prepared to invest in the future of the natural 
products that they sell.
  However, there are some concerns that will be expressed by both the 
public and the industry during the comment period, and I am hopeful 
that the FDA will be responsive, given the FDA's shared commitment to 
deliver products with only optimum health benefits. For example, Mr. 
Speaker, although the GMPs steer dietary supplement manufacturers down 
the right path, there are several outstanding issues that must be 
raised.
  Mr. Speaker, I am concerned about finished product testing and the 
scientifically validated measures to be used. It is crucial that the 
FDA and the dietary supplement industry agree on the methods and 
scientific criteria required of product testing in order for consumers 
to compare products based upon the same standards.
  I recognize that the best standards are those developed from 
scientific and clinical research, and I have always supported efforts 
to promote research and development of dietary supplement products. It 
is imperative that the GMPs include incentives for stimulating clinical 
and scientific research. This research is important for establishing 
scientifically validated methods for dietary supplement testing and for 
providing uniform standards that can be accessed and utilized by 
consumers when comparing the health benefits of supplements.
  In addition, Mr. Speaker, the economic pressure that the GMPs will 
place on small companies, manufacturers and raw material suppliers with 
less than 500 employees, troubles me. Analysis shows that the cost of 
compliance for small companies is estimated at $100,000 the year of 
implementation and $61,000 the following years. The intent of this 
financial burden is to rid the market of unscrupulous players. However, 
small companies and mom-and-pop shops comprise approximately 90 percent 
of the dietary supplement industry, and I fear that many operations 
will be forced to go out of business due to the high cost of 
compliance.
  As currently proposed, it is estimated that up to 50 percent of the 
very small companies could go out of business and that product prices 
could increase by 35 percent. Retailers, small business manufacturers 
and consumers will ultimately have to absorb these costs, which will 
most likely result in fewer consumers being able to purchase dietary 
supplements.
  Mr. Speaker, I would also like to note that GMPs also place a fair 
amount of pressure, economic or otherwise, on the FDA once they are 
finalized. Enforcement of the rules will be costly. One way for the 
U.S. Government to minimize these costs will be to allow independent, 
third-party organizations to conduct inspections and certify 
establishments as if they were government inspectors.
  This is not a unique concept. For instance, the Joint Commission on 
Accreditation of Health Care Organizations accredits nearly all the 
hospitals in the United States.
  Another good example of industry and government cooperation is the 
memorandum of understanding that was established between the American 
Council for Food Safety and Quality, formerly the Dried Food 
Association of California, and the FDA. The MOU allows the association 
to inspect member facilities as if they were government inspectors. The 
program has paid benefits for all involved. The agency would realize 
reduced administrative cost burdens as inspection costs could be borne 
by the manufacturer, while also providing expertise and guidance, 
thereby allowing manufacturers to come into compliance with the new GMP 
regulations.
  Again, Mr. Speaker, I am pleased with the FDA for finally coming 
forth with this proposed rule, and I remain hopeful that the benefits 
will include improved health as a result of better access to quality 
dietary supplements. It is imperative that the FDA use the instructive 
recommendations it receives during the comment period and that the 
public and the industry play a significant role in ensuring improved 
access to safe and effective dietary supplement products.

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