8/7/03

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Dear FDA Administrator, 

Approximately twenty-five years ago, I chose the dietary supplement industry as the arena for my life's work. Today, I applaud the FDA's recent proposed rules regarding our industry. We began implementing the NNFA's GMPs last year. Based on the recent proposals, I am proud to say that many of our current procedures are more stringent than those presently proposed.

One proposed area- testing - gives me great concern and brings into question the survivability of my business. The proposed intensive testing requirements are not feasible because:

A) They are too costly for the small business to implement. We estimate the cost to place minimum required standards, personnel and recordkeeping into our facility to be in excess of $120,000 in the first year (utilizing used equipment).
B) Given the size of our small batch runs, the cost of testing will exceed the cost of production in many cases. 

The proposed GMPs read more like the drug GMPs than the food GMPs they were originally suppose to be based on. We understand that many of the products produced have active ingredients, but few should be treated like drugs. In regards to testing, we are proposing:
1. All finished products be tested for microorganisms and heavy metal content
2. Only raw materials with drug like effects, dangerous health characteristics (i.e. selenium, etc.) and actives that support label claims be tested for identity, purity, quality, strength and composition. 
3. All other raw materials, including; binders, fillers, disintegrants, etc. be assayed only upon receipt to determine assay.

To protect the small business foundation of this industry, we also propose that small batch runs of 25,000 capsules and tablets be exempt from testing if that amount is the maximum consumption for the product per year.

During our twenty-five years in business, our customers have never reported a significant or moderate adverse reaction caused by any of the products we produce.

I wonder if the ends for these proposed rules justify the means, especially in an industry comprised of a disproportionate level of small to large businesses, in particular when the greatest benefit to these proposed rules is a reduced hypothetical search costs as a measure of the benefit from increased assurance of quality.

* How many small businesses will be forced to close shop?
* Will increased costs cause decreased supplement usage and ultimately the overall health of the people who are benefiting now?

I agree with 95% of the proposed ruling but feel the testing proposals place too harsh a burden on the small business manufacturer. We can "raise the bar" on quality without impacting the livelihood of a good portion of the small business suppliers. The dietary supplement entrepreneur needs to have a continued place in the future of this industry!!! 

Finally, please consider changing the requirements for education and experience to education or experience.

Sincerely,


Eric Organ
President
D&E Pharmaceutical, Inc.

CC: 	Senator Jon S. Corzine
     	 Senator Frank Lautenberg
	Representative Scott Garrett
	Scott Bass, NNFA
Karen Strauss, FDA
      
Draft 8/9/2003 4:44 PM