From: Beth [beth@herbalist-alchemist.com] Sent: Monday, August 11, 2003 4:40 PM To: fdadockets@oc.fda.gov Subject: Trouble with Electronic Submission for Docket 96N-0417 Please accept our comments. Tried to file electronically, but rejected by system. Docket No. 96N-0417 BEFORE THE UNITED STATES OF AMERICA DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION COMMENTS OF Herbalist & Alchemist, Inc. ON THE PROPOSED RULE FOR Current Good Manufacturing Practice in Manufacturing, Packing or Holding Dietary Ingredients and Dietary Supplements August 11, 2003 Thank you for the opportunity to comment on the PROPOSED RULE FOR GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING OR HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS (“Proposed Rule”). Herbalist & Alchemist, Inc. is a small company, located in rural Warren County, NJ. We employ 10 people full time, 3 people part-time, and work with some very dedicated independent sales reps. The Company has been in business for 20 years. We purchase the majority of our raw materials directly from small farmers. Known for our reputation of producing high quality, traditional style herbal products, we have a strong commitment to education and to maintaining quality in the industry. Most of our employees have attended, at a minimum, a 2-year, 5 hour a week educational program on botanicals and their uses. We have two professional members of the American Herbalists Guild on staff. Our Product Developer and Chief Herbalist, David Winston, is a well-known ethnobotanist and trained Cherokee Medicine person Our Chief Executive Officer, Beth Lambert, has served on the Board of the American Herbal Products Association for 4 years and was elected Chairman of the Board this year. First, let us state that we support the concept of Industry cGMP’s. As a small company dedicated to quality, we want to see quality in all products made for consumers in our industry. We appreciate the FDA spent a considerable amount of time drafting its Proposed Rule, however we strongly believe that they have underestimated the economic consequences of the Proposed Rule in light of what they have stated to be consumer benefits. We believe the rule as proposed will: · Significantly increase costs to the consumer · Reduce the number of traditional botanicals available to consumers · Drive small, traditional rural-based quality companies out of business · Significantly hurt the rural farming and wild-crafting communities However, we believe that the FDA can achieve its objective of having meaningful cGMPs and providing consumers with high quality products, with some changes to its Proposed Rule. We have worked very hard with our trade association, the American Herbal Products Association (AHPA) to develop such meaningful changes that we believe meet all mutual objectives. I . Preparation for cGMP’s - Investment To Date: Knowing since 1994 that the FDA would issue cGMP’s, we have spent years and invested a considerable amount of money in preparing to meet this, until recently, unknown obligation. To date we have made Investment of at least $52,800 and Annually Spent $84,254 to develop our Quality Standards. Details follow: 1) Documentation and Training - We participated in a year-long ISO 9000 training course and developed our own quality system with documented procedures in conjunction with a consultant assigned to our company over following year. This course was offered by the NJ Department of Labor. All management staff went through procedure writing and audit training. · Investment Cost – Approximately $30,240 in personnel time over a 2-year period and approximately $300 in supplies. 2) Herbarium and Samples – As part of our establishing our botanical standards we developed an in-house herbarium. Plant specimens were keyed and validated by our senior herbalist/ethnobotanist. · Investment Cost – Approximately $2600 in personnel time over a multi-year period and approximately $2000 in supplies. · Annual Cost – Approximately $1268 in personnel time and $150 in supplies. 3) Time to Review and Understand original industry proposed GMP’s and intergrate them into our documented Quality System – a. Read/review by management and staff and meeting time for discussion b. Industry meetings and seminars – including testifying in Washington and attending Washington DC Seminar by FDA on microscopy. c. Integration into Quality System · Investment Cost – $9400 4) Time to Review and Understand FDA’s proposed cGMP’s and prepare responses a. Read/review by management and staff and meeting time for discussion: b. Industry meetings and seminars and e-mail discussions – d. Cost research and comment · Investment Cost – $7355 5) Procedure Maintenance and Audit – Cost to annually maintain procedures and internally audit—18 scheduled audits; document revisions and management review. · Annual Cost – Approximately $11,640 and approximately $200 in supplies 6) Ongoing Going Training to maintain Qualified Employees – Every employee that works with our products is given a basic GMP training course and those directly working in the production area are given intensive training on specific procedures for their jobs. Training is recorded and kept in employee files · Annual Cost – Approximately $500 for General training. Specific Training varies by area and Employee salary. 7) Qualified Employees Highly Skilled in Botanical ID – Company pays for courses in basic Botanical education and advanced Botanical Education where appropriate. Company pays premium compensation to Production staff trained in botanical ID. · Annual Cost – Up to $5000 for Education. Premium salaries range 23-40% over other management/staff for those with Advanced Botanical Experience or Training. 8) Quality Plant Material – The company pays a premium for Certified Organic or Ethically wild-crafted botanicals grown by knowledgeable growers/farmers/collectors. · Annual Cost – Varies, but can be significantly higher. 9) Cost to maintain daily documentation of current procedures – Current level of Documentation adds approximately 15% more time to our production and product sales processes. · Annual Cost –$64,980 for staff time; $250 for data/sample collection and back-up materials (includes $11,640 in #5 above for Procedure Maintenance and Audit). 10) Tape Back-up System- We have maintained a tape back up system for our electronic records for years and just recently upgraded that system. · Investment Cost – Material cost of $724 and $200 for labor for installation. II. Increased Costs to Comply with GMP’s as Written. The standard as written are less strict in some areas than our current internal fully documented procedural standards and add new costs in other areas. We have first tried to analyze the additional cost, the regulations will add as written. We believe we would face a minimum one-time Investment of $189,129 and Annual Costs of at least $561,436 At present we are not certain that we would be able to continue as a going concern without significant restructuring. In addition, when final rules are passed, we might have to make adjustments to our own current system due to the changed emphasis of the FDA. In relying less on internally audited and reviewed procedures and more on testing, the FDA will force us to shift resources to what we believe to be unnecessary testing requirements and building construction burdens that are inappropriate for our class of goods. We believe that these changes will increase costs to the consumers without improving the quality of the products that we are currently delivering to the market. The following reflects our analysis: 1) Sanitize to “achieve a reduction of 5 logs”. Without the change suggested by AHPA, this implies that we would have to prove this issue every time. a. Cost to test before and after: Micro tests cost $320 if above 50% alcohol. We clean surfaces approximately 30 times a day. Not only would this halt production—as we have to send samples out every time, but this is just impractical. AHPA’s simple change would just let us ascertain that we were using a proper cleaner. § Annual Cost: If every time - $2.4 million ($320 x 30 x 250 working days). If 1x per day $87,500 (but these tests take days to culture-have not factored in lost production time.) 2) Training OR Experience—Sections 111.12 (b) and 111 .13 (b) and Section 111.15 training or experience. Working in rural Warren County, we often get job applicants with experience that is relevant to a job, but perhaps without formal training. In hiring that candidate or promoting someone from within our company, we make the judgment that the person has the ability to perform the job, given adequate training, and then through our evaluation process, make the further judgment that the employee is performing the requirements of the job. To have to meet the standard of someone who is both trained and experienced, our search costs would increase, we might not be able to promote our own staff and we would most likely have to increase the amount offered to attract a candidate for a job with very narrow industry experience. Up to 20% increase in staff costs. A simple word change suggested in the AHPA comments relieves this burden. § Annual Cost: $86,600 3) Water supply-we use water supplied by the local water company, which is rated drinkable. Cost for water tests: $30 each. We intend to install filters in the production area. Cost $50 per filter unit per sink. Filters cost approximately $15 to replace. § Investment Cost: $100 § Annual Cost: At least $360 plus testing 4) Smooth/Hard Surfaces in Lab – We approached outside vendors to locate materials that would comply with this requirement. We measured all area, discussed costs of all components with contractors. Cost to up grade current facility estimated to be a minimum of $82,924 for smooth hard surface material and changes lighting/electrical to accommodate these surfaces. That figure might have to be revised upward when we learn more about the type of accommodations for the lighting. We did not actually have our electrician come out to visit our site and spec out the job, as we did not want to have him forego income. This was an estimate. A simple change as suggested by AHPA comments to cleanable surfaces would be sufficient. § Investment Cost: $82,924 5) Requirement for fans and other air-blowing equipment/Equipment that controls temperature and humidity. The way this section is written it requires fans and other air-blowing equipment or equipment to control temperature and humidity. Given that we live in rural NJ in a temperate climate, we do not always need this equipment. We, of course do use fans, air conditioning and heating as appropriate to prevent adulteration and maintain a comfortable working environment, but some days, in our judgment, we don’t need anything. Again AHPA’s simple changes relieves this burden. § Investment Cost: $need more research 6) Raw Material receipt area construction. Often we receive material directly from a grower that requires additional washing before we bring these material into our processing area. Similar, but in most instances cleaner than the area they would have been gathered in, we have an outside washing station. It has a concrete base and is elevated. We perform final washing and often will examine plant material for foreign material at this station, before it is brought into our production area. If we would have to create a separately enclosed area for this purpose, we would incur significant initial costs. Here again, AHPA’s changes to reflect procedures that insure that standards are met appropriately would take care of this issue. § Investment Cost: $25,795 for new structure, not including installation. 7) Instrument calibration, when instrument not critical to achieving specifications. Press, moisture balance a. Currently calibrate our balances according to procedure. To purchase additional weights to calibrate more frequently in house § Investment Cost: $400 to $1400 b. Other instruments, such as our press, graduated cylinders, measuring spoons and cups are not currently calibrated. Weight is the defining component of the relationships established by the Master Manufacturing Record. AHPA’s wording change would relieve this burden. § Investment Cost: $need more research 8) Testing Requirements a. Botanicals-we consulted a leading outside testing lab to ascertain the costs of the following tests. Last year we received 200 lots of botanical material and made 178 products (note some botanicals were repackaged as smaller sizes of bulk dried herbs). Applying the test costs outlined below, which depending on the product would range from between $825 to $975 per product, we would increase costs by $311, 850 to $368,550. These testing costs alone represent a 327% to 368% increase in our total cost of goods sold. Some products we make in very small batches to accommodate traditional uses. We would obviously no longer be able to make these products—and we would have to increase prices on our other products. We have been 20 years in business without a recall, primarily purchase certified organic herbs, and have invested significantly in a documented quality system with procedures to avoid such problems. This represents an enormous cost to the consumer, without delivering any observable benefit. Our prices would have to increase immediately by a significant amount to just to cover these costs. AHPA’s changes, though complicated in this area, are standards that accommodate our scale of production. i. ID- TLC $150 ii. Micro - $350-360 if below 50% alcohol and $320 if above 50% alcohol iii. Pesticides - $225 iv. Heavy Metals - $150 v. Aflatoxins - $100 b. Ingredients (Alcohol, Water, Glycerine, Vinegar, Essential Oils, etc.) With 28 lots received in 2002, the additional costs would be $23,100 to $27,300. We believe that it is unreasonable to have to verify goods already made to USP standards. AHPA’s changes reflect this issue. We would review procedures to make sure we meet standards. · Annual Cost: $334,950 to $395,850 9) Software back-up – It is illegal in most instances to copy software. And our software is constantly being updated. We keep records and have invested in a tape back-up system. · Investment Cost: $924 (already made see above) 10) Establishing a quality control unit-we have an existing Quality system with checks and approval built into that system. With 200 botanical lots and 178 finished products and 28 lots of ingredients that will need to be tested, we will have to add at least one additional person, just to track test receipts and sample submissions to outside labs. Again AHPA’s changes reflect our work done to date to meet the “spirit” of this issue. · Annual Cost: at least $35,000 plus full health benefits and 401k costs. a. Additional Sample costs · Annual Cost: $need more research 11) Master Manufacturing Record Upkeep and Changes - In Video Tape Presentation by FDA staff of the proposed regs, there was a discussion indicating that the “Master Manufacturing Record” must indicate a Specific Quantity and Weight for each ingredient see 111.45 (b) (3) —BUT 1.. Our Product Master File and BOM’s set relationships, not specific quantities. Each record is then developed from the amounts input—most often for an extract batch, it is a function of the raw material weight after garbling out inferior material (excess stem, grass seed. etc.) 2.. As a small company, we often bottle large sizes to demand and adjust quantities for manufacture and bottling, based on demand and product availability. The specific RELATIONSHIPS are therefore defined by the Product master file or BOM, but the batch size of bottling run is calculated, based on product availability. Our lab and bottling managers have been trained to perform those calculations. And our procedures provide adequate checks on their calculations. 3.. Our output is a flow based output. Amounts vary by press used. For certain products, volume returns can be over 100%, for certain highly resinous materials on rehydration. We have a reasonable expectation of output based on history, exceptions are examined. Very simple changes submitted by AHPA take care of this issue. Annual Cost: at least $11326 for changes, record-keeping and audit. 12) Additional Documentation a. Documentation of “Standards” to comply with Regs-Staff and Management time to write-up, format and review existing standards $57750. b. Review of Procedures to make sure they comply with New cGMP’s-internal audit and re-write at least $22160 · Investment Cost: at least $79,910 13) Returns Costs-we have internally established standard to accepting returned finished stock as qualified for resale. Product must be examined and meet our standards. Most of our business is wholesale. Returns accepted are returned within a short time, ie wrong item ordered or sent—seals must be intact, labeling acceptable, etc. If we lose the ability to set our own standards for such items, we incur the indicated cost. Again, AHPA changes reflect the need to set our own standards: · Annual Cost: at least $5700 III. Requested Changes that will not compromise the intent of FDA’s mission of Quality Industry Products and Consumer Safety, but that will ease the cost burden of Proposed cGMP’s for Quality, Traditional, Small Botanical Products Company. 1) American Herbal Product Association Submission - We have spent a considerable amount of time participating in Trade Association Meetings to review the proposed cGMP’s. We support all comments and changes proposed by The American Herbal Products Association in its submission, particularly its detailed mark-up of the FDA’s cGMP’s. We have submitted specific comments, which have been incorporated in AHPA’s Documents. We thoroughly believe that we will bear increased costs especially in the areas outlined below: · Reviewing our existing documentation (most significantly reviewing all raw material and product standards and make sure that our botanists/herbalists have complete files that reflect their knowledge) – o Investment Cost: $79, 910 o Annual Cost: $need more research · Adding additional filtration for water supply (which is already delivered by a water company who has to meet drinking water requirements) · Investment Cost: $100 · Annual Cost: At least $360 plus testing but that these costs can be borne by increasing operating efficiencies and by increased prices to the consumer. We believe that consumers will accept these costs. 2) We support American Herbal Pharmacopoeia (AHP) as a standard setting entity. Our trade association, the American Herbal Products Association, has indicated its support for the scientifically valid standards established by the American Herbal Pharmacopoeia (AHP), the European Pharmacopoeia (EP), and the World Health Organization (WHO). We strongly support this position. Combined, these three organizations have developed standards for more than 100 different botanicals as reflected in their currently completed monographs. The monographs of AHP and WHO contain methods of identification not contained in other sources, such as accurate morphological and microscopic descriptions. AHPA notes that non-chemical analyses, such as organoleptic and microscopic analyses, are extremely important, and often times more useful, in determining plant identity. Thus, methods or references that are relevant to these methodologies are essential. Additionally, each of the monographs of these organizations have been developed and reviewed according to rigorous guidelines and subjected to international peer review prior to their adoption. AHPA has found the AHP monographs to be among the most useful and scientifically credible sources of information about botanical ingredients, including information on identity testing and quality control parameters. Unlike other authoritative sources, AHP monographs provide numerous illustrations and photographic images detailing the gross and microscopic characteristics of each botanical, along with detailed chromatographic imagery relevant to chemical analysis. This information provides a valuable resource for assuring identity and quality of botanical ingredients, as a production sample received by a firm can be tested with the various methods and references published in these texts. AHP monographs also provide information regarding optimal harvest times and handling and drying conditions. These parameters are valuable for botanical ingredient quality control and are not addressed by any of the identified compendial sources. The information in the AHP, EP, and WHO monographs is extremely valuable to AHPA members, such as our company-Herbalist & Alchemist, in complying with cGMPs and should be recognized as such by FDA as scientifically credible resources for identifying botanical dietary ingredients. Such recognition would provide AHPA members and other manufacturers with clearer guidance to assist in accessing internationally recognized standards for more than 100 botanicals.