From: ALOEDoc@aol.com
Sent: Monday, August 11, 2003 4:27 PM
To: fdadockets@oc.fda.gov
Subject: commentary on docket#96N-0417


Dockets Management Branch
Food & Drug Administration
Room 1061
5630 Fishers Lane
Rockville, MD 20852

Re: Docket # 96N-0417

August 8, 2003

To whom it may concern:

Concerning the FDA’s Proposed Rule for Current Good Manufacturing Practice 
for Dietary Supplements I have the following comments, concerns and suggestions:

V Subpart E

My main concerns are regarding Subpart E and I would like to address it as a 
unit as opposed to comment on each sub paragraph. As I understand this section 
what is proposed is that every raw material in a dietary supplement, even 
though a certificate of analysis is received from a reliable vendor, must be 
analyzed to verify its composition, purity, identity, quality and strength. The 
finished product then must be analyzed upon completion to verify the existence 
and quantity of every ingredient. My concerns are as followed:

1. For my manufacturer to analyze both the raw materials and the finished 
products for every batch for every ingredient would make it cost prohibitive for 
me to produce my products. The price to the stores I supply and then to the 
consumer would be more than twice what they are now. I am concerned that the 
efforts to protect the consumer will result in denying them the opportunity to 
afford dietary supplements of quality.
    a. I offer the suggestion that requiring analysis of finished products   
       on a random ‘spot checking’  basis may be enough to pull unscrupulous  
        manufacturers in line as well as demand quality manufacturers.
    b. I offer the suggestion that the certificate of analysis that comes 
        with the raw materials be sufficient to identify what the raw 
         materials contain as long as the materials are sealed properly and  
         have stayed sealed. Perhaps stricter regulations on sealing         materials 
(random spot checking these suppliers may also encourage         honesty).
    
2. Perhaps for certain ingredients it is easy to identify and analyze like 
synthetic vitamins and identifiable minerals. But as I understand it, in 
addition to excessively expensive, it is sometimes almost impossible to identify all 
the naturally occurring ingredients in herbs and plants. As I understand it, 
trying to analyze these would be very cumbersome, costly, time consuming and in 
some cases impossible at this point in time and science.
    a. I offer the suggestion that certain ingredients of concern to public 
       safety flagged and required to be analyzed for identity and quantity 
        in finished products as opposed to all ingredients.
     b. I offer the suggestion that when it comes to complex products with 
         herbs and plants the analysis of quantity be sufficient (in 
         addition to current purity regulations) and again, I feel that this 
         quantity analysis on a spot-check basis might be sufficient to          satisfy 
‘good manufacturing’ practices.
     c. I offer the suggestion that perhaps with more complex plant and 
        herbal supplements that are difficult, costly and time consuming to 
        analyze that a quantifying and qualitative curve “fingerprint’ of a 
        given product be established to which future batches can be compared         on 
a ‘spot check’ basis.
 ****d. I offer the suggestion that we have different classifications that 
       allow whole herbs to be classified as foods with nutritional value. 
        1. I produce herbal enhanced aloe vera liquids. The aloe as well 
            as the herbs will be impossible and prohibitively expensive to 
           analyze in the detailed manner this docket suggests. I am asking 
           if for herbs and plants, where processing does not alter their 
           original natural biochemistry (not tinctures) that this detailed 
           'ingredient' analysis' be waived as the 'ingredients' are             naturally 
occurring designs of Nature. 

I commend your efforts to place high standards on manufacturing practices.  I 
feel that the regulations already in place could be sufficient if followed 
and enforced (perhaps with random checks). If there are certain ingredients that 
require stricter enforcements perhaps you can impose these stricter 
regulations to those chosen ingredients.

I have a small supplement distribution company. I chose my manufacturer based 
on his honesty and integrity in following all regulations to the letter and 
beyond. I trust that the products he produces for me are true to the labeling 
information provided to me. I am all for enforcing adherence to safety, purity 
and honesty in manufacturing and labeling. However, I am concerned  that if 
excessive detailed analysis for every raw material that goes into my products 
and analysis for every ingredient once the product is finished would not only be 
cost prohibitive for small companies like mine but also for the retailers and 
consumers as well as cripple timely production. 

I am trusting that you will seriously consider all the ramifications of these 
proposed regulations to small businesses and consumers and find the right 
balance: to ensure honest and quality manufacturing practices; drive the quality 
of supplements by allowing healthy competition including small businesses; 
while at the same time protecting the consumer by assuring safe, honest products 
and protecting  their rights to be offered cost effective quality dietary 
supplements. 

Thank you for your time and consideration. I depend on you to keep our 
industry honest and productive.

Sincerely,


Dr. Jeri L. Heyman, PhD
President
Herbal Answers, Inc.
aloedoc@aol.com
PO Box 1110
Saratoga Springs, NY 12866