IAHF Webmaster: Breaking News, Whats New, What to do, All Countries
IAHF List: In my previous message I asked all of you to please join me in sending the FDA comments regarding their proposed rule on Good Manufacturing Practice Regulations for Dietary Supplements.
I provided you with the comments to send to the FDA by August 11th, and I directed you to an FDA website where you can send them via a form they have. After telling you how you can do this, I tried sending the FDA my comments and FDA gave me an error message indicating that their form did not successfully transmit FDA my comments.
There is an ALTERNATIVE WAY to send the comments to FDA:
Please use this email address: email@example.com
Again: Here are the comments to send- please just modify my introduction to add a few words of your own in place of mine and sign your own name and address, but send them attorney Jonathan Emord's comments as I have below. You can do this no matter what country you live in, and thanks!
FDA: I agree with Jonathan Emord's comments regarding
Docket No. 96-0417 Good Manufacturing Practice regulations for dietary supplements (see his comments below)
By sending this to you I have standing to sue you over the illegal GMP regs you're about to come out with for dietary supplements which will be even more stringent than pharmaceutical GMPs.
I realize you intend to attempt to attack the dietary supplement industry by using site licensing as a weapon the way the TGA did in Australia where they pulled 1600 products off the shelves under false pretenses, but don't even THINK about trying that in America!
DSHEA only allows you to come out with FOOD BASED GMPs for dietary supplements, but you're attempting to destroy all the small supplement companies under an avalanche of uncessary red tape. Emord will be suing to get an injunction in Federal Court to stop you from enforcing an illegal law, so you better pay attention to his comments below and save yourself the humiliation of being sued successfully again.
John C. Hammell, President
International Advocates for Health Freedom
POB 10632 Blacksburg VA 24062
FOOD AND DRUG ADMINISTRATION
In re: FDA Advance Notice of Proposed ------------)
Rule Making, 62 Fed. Reg. 5700 --------------------)
(Feb. 6, 1997); Current Good -----------------------) -----Docket No. 96-0417
Manufacturing Practice in Manufacturing ------------ )
Packing, or Holding Dietary Supplements ----------- )
COMMENTS OF PURE ENCAPSULATIONS, INC.; DURK PEARSON AND SANDY SHAW; MINERAL RESOURCES INTERNATIONAL, INC; TRACE MINERALS RESEARCH, L.L.C.; AND AMERICAN NUTRITION CORPORATION
Pure Encapsulations, Inc.; Durk Pearson and Sandy Shaw; Trace Minerals Research, L.L.C.; and American Nutrition Corporation ("Joint Commenters"), by counsel, pursuant to 21 C.F.R. § 10.20, and in response to 62 Fed. Reg. 5700 (Feb. 7, 1997), hereby submit these comments in response to the FDA's advance notice of proposed rulemaking in the above referenced proceeding.
BACKGROUND AND INTEREST OF THE JOINT COMMENTERS
Pure Encapsulations, Inc. Pure Encapsulations, Inc. (Pure) is a Massachusetts corporation engaged in the business of manufacturing, distributing, and selling dietary supplements for human and companion animal consumption. Pure has a state of the art facility that produces safe, high quality supplements but is concerned that the proposed CGMPs will cause it, and other small manufacturers like it, to suffer substantial economic hardship. The increases in costs associated with higher overhead, new equipment purchases, greater recordkeeping, and staff training and certification, among other requirements, will force Pure to increase the price of its products, decrease the number of products it offers, and reduce productivity by shifting staff time from manufacturing to regulatory compliance activities.
Durk Pearson and Sandy Shaw. Pearson and Shaw (P&S) are scientists, maintaining residences in Nevada and California, who design dietary supplement formulations and license them to small companies. The formulations designed by P&S are purchased by approximately 200,000 consumers. P&S and their licensed manufacturers would suffer substantial economic harm if the proposed CGMPs are adopted. The proposed CGMPs will increase the costs of production, decrease the number of products offered by their licensees to the public, and reduce their licensees' productivity, resulting in lower royalties to P&S from sales of the products.
Mineral Resources International, Inc. Mineral Resources International, Inc. (MRI) is incorporated in Utah and engages in the business of manufacturing, distributing, and selling dietary supplements containing minerals that MRI has harvested from the Great Salt Lake combined with other dietary ingredients (including botanicals, minerals, vitamins, and amino acids). MRI has a state of the art facility that produces safe, high quality supplements but is concerned that the proposed CGMPs will unnecessarily increase MRI's costs of production and recordkeeping, decrease the number of products MRI can offer the public, and reduce MRI's productivity because it will have to shift staff from production to regulatory compliance matters.
Trace Minerals Research, L.L.C., Trace Minerals Research, L.L.C. (Trace) is established in Utah. Trace markets and distributes MRI's products to dietary supplement retailers in the United States. Those products have been used safely by consumers since the inception of Trace's predecessor company over twenty-eight years ago. If the proposed GMPs are adopted, Trace will have to pay MRI increased costs for product which, in turn, will have to be passed on to consumers, resulting in an unnecessary increased cost to its consumers. Trace will also experience increased costs for recordkeeping and will have to shift staff from marketing to regulatory compliance.
American Nutrition Corporation. American Nutrition Corporation (ANC) is incorporated in Las Vegas, Nevada, and is engaged in the manufacture and distribution of dietary supplements. The proposed CGMPs will increase ANC's costs of production and recordkeeping, decrease the number of products ANC can offer its customers, and reduce ANC's productivity because it will have to shift staff from production to regulatory compliance matters.
The agency's authority to commence this rulemaking is derived from 21 U.S.C. § 342(g), which permits (but does not require) the Secretary (and, by delegation, the Commissioner of Food and Drugs) to prescribe good manufacturing practices for dietary supplements. The primary issue presented in the agency's advance notice concerns whether the adoption of CGMPs is warranted for the dietary supplement industry and, if so, whether the draft CGMPs submitted to the FDA by the National Nutritional Foods Association (NNFA) should be adopted in whole or part. The FDA also seeks comment on whether (1) to develop specific defect action levels for dietary supplements; (2) to develop testing requirements to identify the dietary ingredients in dietary supplements; (3) to develop standards to be met by dietary supplement companies in certifying that a dietary ingredient or supplement is not adulterated; (4) to require procedures to document that a manufacturer is following CGMPs; (5) to refer adverse incident reports to medical authorities to evaluate the public health risks involved; (6) to require manufacturers to institute specific procedures to identify, evaluate, and respond to safety concerns; (7) to require manufacturers to institute specific controls concerning computer controlled and assisted manufacturing operations; (8) to require Hazard Analysis and Critical Control Points rather than the proposed CGMPs; and (9) to promulgate regulations that address specific segments of the dietary supplement industry rather than the universal approach in the proposed CGMPs.
If the proposed CGMPs are adopted, the agency will acquire for the first time a mandate to regulate, comprehensively, (1) the personnel hired by manufacturers; (2) the manufacturing plants of, and grounds surrounding, dietary supplement companies; (3) the quality assurance and adverse incident reporting and recording of dietary supplement companies; (4) the quality assurance procedures used at dietary supplement companies; (5) the sanitation procedures followed by dietary supplement companies; (6) the equipment used at dietary supplement manufacturing plants; and (7) the procedures used to house and distribute dietary supplements.
The Joint Commenters oppose adoption of the proposed CGMPs for the following reasons, explained in detail herein: (1) the dietary supplement market is far safer than the food and drug markets, militating against reliance on CGMPs in the former; (2) brand name recognition, private certification, and products liability already provide safety and quality assurance in the dietary supplement market; (3) the proposed CGMPs are a disproportionate response to a market in which safety is the norm and harm occurs in extremely rare, isolated, readily identifiable instances; (4) existing FDA adulteration and misbranding regulations and state and local health regulations provide adequate protection for the public; (5) the proposed CGMPs will benefit large dietary supplement companies and harm small ones by substantially increasing costs of production (and imposing a disproportionate burden upon them); (6) the proposed CGMPs will increase the cost of dietary supplements and substantially reduce innovation to the detriment of consumers without increasing relative dietary supplement safety and quality; (7) the "one-size-fits-all approach" of the proposed CGMPs lacks scientific and economic merit given the extraordinary diversity of ingredients and forms of dietary supplements in the market; (8) the proposed CGMPs suffer from fatal ambiguities that provide inadequate guidance to agency inspectors and invite arbitrary and capricious enforcement; (9) the agency lacks resources necessary to enforce the proposed CGMPs adequately; (10) the proposed CGMPs will not affect those few who currently violate the law by producing adulterated and misbranded products; and (11) the Dietary Supplement Health and Education Act (DSHEA) creates a presumption in favor of the safety of dietary supplements and precludes adoption of procedures requiring manufacturers to prove safety in the absence of evidence of harm.
Rather than impose mandatory or voluntary CGMPs on the entire industry (forcing the vast majority of companies that produce safe products to bear added costs unnecessarily), the Joint Commenters recommend that the FDA take stock of the relative safety of the dietary supplement market, note that the threat to public health is far less than in the food and drug markets, and focus enforcement efforts upon those identifiable few who sell adulterated and misbranded products. The current case-by-case enforcement approach is fully capable of correcting the comparatively few and isolated instances of harm that have arisen in the dietary supplement market; there is no need for the additional regulatory controls proposed in the GMPs. If in future the agency finds that a specific kind of supplement is associated with systemic and repeated instances of mismanufacture harmful to the public, it may then elect-with just cause-to adopt voluntary CGMPs for that supplement alone, to aid the industry in avoiding production practices responsible for the harm. This approach comports well with the agency's new emphasis on cooperative efforts to achieve compliance and leaves the agency's enforcement power under the misbranding and adulteration provisions at the ready if voluntary compliance is not attained.
If adopted, the proposed CGMPs would not result in a net improvement in consumer welfare and, indeed, would reduce that welfare by driving out of the market small companies, by imposing significant financial burdens on mid-level companies, by creating barriers to entry and innovation that will enhance the market shares of large companies without corresponding consumer benefit, by increasing the cost of all dietary supplements, and by decreasing the number and kind of supplements available to consumers. As Dr. Steve H. Hanke (former Senior Economist on the President's Council of Economic Advisors and Professor of Applied Economics at The Johns Hopkins University) and Dr. Stephen J. K. Walters (Professor of Economics at Loyola College in Maryland) state in their report appended to these Joint Comments:
We conclude that the proposed regulations will not produce an increase in public safety-and may even reduce it. In addition, such regulations will lead to a more concentrated, less competitive industry; this will raise prices to consumers and significantly reduce research productivity and the rate of innovation in this dynamic industry. In sum, consumers will pay more for a restricted array of products, and in return will receive no greater level of safety from product defects than they currently enjoy. Clearly, regulatory resources are limited; there must be many higher-valued uses of the resources which would be consumed should the proposed CGMP regulations be implemented.
In addition, the market for dietary supplements is far safer than that for foods in common form and drugs. CGMPs are thus a disproportionate response to the extremely rare, isolated, individual harms that may arise from time to time in the market. Moreover, consumer driven market forces, products liability suits, and existing federal and state laws provide fully adequate protection for consumers against the comparatively few harms that arise in the market. Those forces impose blame and mete out punishments on the few wrongdoers (precisely those who are least likely to abide by CGMPs if adopted) rather than on all others who produce safe products (precisely those who do not need the proposed CGMPs).
A. THE DIETARY SUPPLEMENT MARKET
IS FAR SAFER THAN THE FOOD AND DRUG MARKETS
In the report attached (Appendix A), Dr. Harry G. Preuss, M.D., F.A.C.N., Professor of Medicine and Pathology at Georgetown University Medical Center, confirms that the dietary supplement market is characterized by a degree of safety far superior to the food and drug markets. Dr. Preuss reports that vitamins "are extremely safe based on various surveys carried out by the American Association of Poison Control Centers (AAPCC), the physician reporting service of the American Medical Association, and the U.S. Public Health [Service's] Center for Disease Control." The AAPCC reviews for the years 1983 to 1990 show no deaths directly attributed to vitamins as compared to 10 million cases of poisonings, including 2556 fatalities, from pharmaceuticals over the same period. Foods, by contrast, are far more dangerous than either dietary supplements or drugs. Just one food borne toxin, salmonellosis, renders between two and four million Americans ill every year. Dr. Preuss concludes:
. . . [W]hen comparing pharmaceuticals and foods with supplements, the potential for toxicity of the latter is far less than for the two former categories. Toxicity is rare with supplements . . . With little risk involved, it is worth allowing these products on the market in an unencumbered fashion . . .
See Appendix A.
The safety of dietary supplements (as compared to foods in common form and to drugs) greatly undermines the argument that CGMPs are needed comparable to those for foods and drugs. Dietary supplements have been consumed safely in the United States in one form or another for over one hundred years. It is presently estimated that nearly 40% of Americans (a conservative estimate of 135 million individuals) use some form of dietary supplementation today. See Appendix A. Throughout the period of recorded supplement history, dietary supplements have enjoyed a remarkable record of safe consumption. From 1983 to 1994, there has not been one reported fatality connected to the consumption of vitamins and minerals. During that same period, there were at least 2556 fatalities associated with the ingestion of pharmaceutical products. Approximately 9000 deaths occur annually due to consumption of contaminated foods. Unlike dietary supplements, foods in common form provide an excellent medium for the growth of bacteria and bacteria-produced toxins. A recent five year report by the CDC identified Salmonella Enteritidis as the leading cause of food poisoning and death in the United States. There are no reported deaths from Salmonella poisoning associated with dietary supplements. Other maladies associated with food and not associated with dietary supplements are (1) staphylococci associated with dairy products and poorly cooked meat and fish; (2) botulism associated with poor canning and preserving of foods; (3) trichinosis in pork; (4) E coli in beef; (5) cyantotoxins and hepatitis in seafood; (6) aflatoxins in peanuts; and (7) toxins associated with the ingestion of certain mushrooms. See Appendix A.
Moreover, the dietary supplement market is characterized by forces that ferret out and punish those few companies that sell inferior quality products. In the second study attached (Appendix B), Drs. Steve H. Hanke (former Senior Economist to the President's Council of Economic Advisors and Professor of Applied Economics at The Johns Hopkins University) and Dr. Stephen J. K. Walters (Professor of Economics at Loyola College in Maryland) explain the nature and effect of these market mechanisms.
B. BRAND NAME RECOGNITION, PRIVATE CERTIFICATION, AND PRODUCTS LIABILITY ALREADY PROVIDE ADEQUATE SAFETY AND QUALITY ASSURANCE IN THE DIETARY SUPPLEMENT MARKET
The high comparative safety of the dietary supplement market enables market mechanisms and products liability to provide both a necessary and sufficient deterrent to the sale of shoddy products in that market. Brand name recognition enables consumers to differentiate among available products on the basis of quality. As Drs. Hanke and Walters explain:
The most important mechanism . . . is consumer reliance on brand-names. Simply put, a firm's brand-name or reputation serves as collateral-more formally, as a forfeitable collateral bond-that will depreciate if consumers are disappointed in the quality of the product the firm provides. Before risking their money (or safety) on the purchase of a product about which they know relatively little (compared to the seller, who likely knows whether the product has actually been produced using 'good practice' or not), consumers want to know that the seller has something to lose if the product proves to be of lower-than-anticipated quality. Thus, consumers rationally resist buying the products of "unknown" sellers. Sellers' brand-names or reputations are useful to consumers because, once a name or reputation has been created-often at considerable expense-it is an asset that depends for its value on consumers' continued favorable opinion of the firm. In seeking to maintain the value of their brand-name assets, firms will have very strong incentives to satisfy consumers expectations about product quality and safety.
See Appendix B.
That is not to say that adulteration does not take place but, rather, that its occurrence is rare-insufficient to justify the burden and expense (on the industry and the government) associated with a general imposition of regulations on manufacturing, packing, and holding dietary supplements.
Private certification also enables producers and consumers to differentiate on the basis of quality. Efforts are currently underway by a number of entities, including the NNFA, to develop systems for the private certification of dietary supplement ingredients and of supplement purity. Those efforts will add to information that consumers may use to differentiate among products, fostering the further development of consumer driven incentives for firms to label products accurately and maintain and improve quality and purity.
Finally, private causes of action, including products liability suits, carry with them harsh penalties. Companies engaged in wrongdoing not only suffer direct financial penalties from litigation costs and adverse judgments but also indirect financial burdens as consumers angered by a breach of confidence penalize the responsible company by purchasing competing products or leaving the market altogether.
C. THE PROPOSED CGMPs ARE A DISPROPOTIONATE RESPONSE TO A MARKET IN WHICH SAFETY IS THE NORM AND HARM OCCURS IN VERY RARE, ISOLATED, READILY IDENTIFIABLE INSTANCES
As Dr. Preuss explains in Appendix A, the dietary supplement market differs greatly from the market for foods and the market for drugs. While "many foods, unlike pharmaceuticals and supplements, provide an excellent media for the growth of pathogens," dietary supplements rarely have associated with them the illness and death attributed to foodborne pathogens. While adverse reactions are not uncommon for xenobiotic substances used for the treatment of disease, dietary supplements-typically comprised of purified constituents of foods, vitamins, minerals, or botanicals (used for centuries)-rarely have associated with them comparable adverse reactions.
In the dietary supplement market, with rare exceptions, consumer harms have not been associated with the products themselves but with isolated and readily identifiable instances of adulteration or misbranding. Adulteration and misbranding are bound to occur even with CGMPs because the more powerful legal sanctions currently in federal and state law against adulteration have not prevented the violations.
Because the record of safety for dietary supplements vastly exceeds that for foods in common form and for drugs, it is not appropriate to regulate the manufacture, packing, and holding of dietary supplements in a manner akin to either foods or drugs. Such a response would be wholly disproportionate to the nature and degree of risks present in the dietary supplement marketplace. Rather, given the remarkable safety record for supplements, the appropriate response is to discern precisely what products or what companies in the market have a history of harm to consumers. If those products are isolated and readily identifiable then an industrywide approach is inappropriate. If those companies are atypical then an industrywide approach is inappropriate. Instead, a tailored regulatory response under existing law would be both necessary and sufficient. An industrywide approach under circumstances of very rare, isolated, readily identifiable harm constitutes regulatory overkill: the economic hardships imposed on producers of safe products and the limitations imposed on consumer choice outweigh the slight improvements in safety and quality that might be attainable. The appropriate regulatory response is to rely on existing laws to impose corrective guidance (e.g., recommendations tailored to rectify a specific company's problems) or sanctions, where appropriate, on a case-by-case basis on those companies that fail to produce safe products.
D. EXISTING FDA ADULTERATION AND MISBRANDING
REGULATION AND STATE AND LOCAL HEALTH REGULATIONS
PROVIDE NECESSARY AND SUFFICIENT PROTECTION TO THE PUBLIC
Based on the history of safety in the dietary supplement market, documented in Appendix A, harms to the public may be said to be very rare, isolated instances not representative of either all, or even most, products or all, or even most, companies in the dietary supplement industry. Under these circumstances, the statutory provisions authorizing enforcement against acts of adulteration and misbranding provide the FDA with all authority it needs to remove from the market the bad actors. 21 U.S.C. §§ 342(a), (f) and 343(s). In addition, state and local health and zoning regulations already provide a patchwork quilt of regulatory law closest to the site of production that governs facility design, grounds, and operation of dietary supplement manufacturing facilities. To be sure, the proposed CGMPs would create substantial overlapping regulation that would invite conflict between state and local authorities, on the one hand, and the federal government, on the other.
THE PROPOSED CGMPs WILL BENEFIT LARGE DIETARY
E. SUPPLEMENT COMPANIES AND HARM SMALL ONES BY SUBSTANTIALLY INCREASING OVERHEAD COSTS
The regulatory compliance costs created by the CGMPs will increase all dietary supplement companies' fixed or overhead costs. The impact of those costs will be heavier on small firms with low production outputs than on large ones with high outputs, affording large firms a considerable competitive advantage. Drs. Hanke and Walters explain:
The proposed regulations will have unambiguous and negative effects on industry structure and conduct. Since regulatory compliance costs will add to firms' fixed or overhead costs, they will impose a greater relative burden on small firms, which produce smaller volumes over which to spread these costs. Thus, the regulations will cause average costs to rise for all, but the increase will be proportionately greater for small firms. As a result, the proposed regulations undoubtedly will tilt the competitive playing field in this industry toward larger firms.
Increased costs will render the market less competitive by driving certain companies out, raising new barriers to market entry, and increasing product prices. Drs. Hanke and Walters explain:
The result will be that the number of competitors in this industry will fall, because smaller firms will be forced out of this market by larger firms which will now have a competitive advantage and because the regulations will raise new barriers to market entry over time. In consequence, this market will move away from its current atomistic structure and will become significantly more concentrated and less competitive; thus, prices and margins will rise and the gains from exchange in this market will be significantly reduced.
Drs. Hanke and Walters believe the proposed CGMPs will stifle innovation in the market by eliminating R & D budgets of smaller firms that must devote a larger percentage of their revenues to regulatory compliance matters. Appendix B.
Alpha Consulting Labs of Chicago conducted an expert evaluation of the costs associated with the various kinds of testing required to assure compliance with the CGMPs. See Appendix D. Alpha estimates that the increased cost would be substantial for smaller firms but would be absorbed by the larger ones, revealing the disproportionate impact of the proposal: "Large manufacturers have in-house laboratories with complex instrumentation and highly skilled human resources that could meet these requirements. A great economic burden would be placed on all other manufacturers who do not have or cannot afford the technical resources needed." Appendix D. Assessing the cumulative impact of the costs imposed by the CGMPs, Alpha concludes that "[l]arge companies could meet these proposed requirements with some difficulty and significant expense" but "[s]maller companies would have a very difficult, if not impossible, task to meet them."
Joint Commenter Pure estimates that the proposed CGMPs would have a profound impact on its current business. Pure estimates that it would have to eliminate up to 35% of its product offerings, increase its prices, or increase its batch sizes. Elimination of 35% of Pure's product offerings would mean an economic loss of $1.5 million to $5.0 million in sales per year. Pure would be forced to terminate the employment of between 7 and 8 of its manufacturing and clerical staff. Increased costs would have to be passed on to consumers at between $.01 and $.15 per capsule, or $.60 to $9.00 per bottle of sixty capsules. Consumer prices would increase to between 30 and 200%, depending on the current price per bottle. See Appendix C.
F. THE PROPOSED CGMPs WILL INCREASE THE COST OF DIETARY SUPPLEMENTS WITHOUT INCREASING THEIR RELATIVE SAFETY AND QUALITY
As explained above, the regulatory costs imposed by the proposed CGMPs will benefit large firms and harm both small firms and consumers by producing concentration in the market, reducing the number and variety of dietary supplements, driving out small companies, and forcing consumers to pay higher prices. These substantial economic dislocations could conceivably be offset by a demonstrably large improvement in safety and quality were it not for the fact that the dietary supplement market is the safest of the ingestible product markets. A large improvement in safety and quality is thus not possible because market safety is the norm. As a consequence, the economic losses attendant to the proposed CGMPs will not be offset by a corresponding and noticeable improvement in consumer safety. The net result will be a loss in consumer welfare.
Moreover, and ironically, the loss may also be to consumer health. Drs. Hanke and Walters note that resources available to the agency are not sufficient to enforce the proposed CGMPs adequately. Yet the mere existence of those CGMPs will cause consumers to believe that their Government has taken all steps necessary to ensure the safety of dietary supplements in the market. That not being the case, however, consumers may be more apt to be defrauded into buying inferior quality products on the producer's assurance, or the consumer's mistaken belief, that Government standards are in place and are being met. Drs. Hanke and Walters explain:
Under [the proposed regulations] . . . , consumers may be more apt to risk purchasing 'unbranded' product or the products of 'unknown' producers. The idea that 'the government wouldn't let them sell it if it wasn't safe and effective' will take root. Of course, regulatory enforcement resources are limited; it will be essentially impossible for regulators to authenticate the claims of all producers. Nevertheless, the appearance of oversight by regulators will give a boost to "fly-by-night" sellers; they will no longer need to make heavy investments in brand-name or reputation in order to induce trials by consumers.
Unless the regulatory authority is willing to commit massive resources to enforcement, then, the safety implications of the proposed regulations are, at best, ambiguous. Replacing the market-based safety-and quality-assurance mechanism with a regulatory system that is enforced with less than perfect efficiency may reduce the probability that the products of an established seller are unsafe or ineffective, but will also certainly increase the probability that a consumer will buy the product of an unscrupulous seller. We believe there is a great probability that the latter effect will dominate, and that regulation will have a negative effect on safety in this market-as it has in several others.
Thus, it is not simply that the proposed CGMPs will fail to effect an improvement in dietary supplement safety and quality, they may in fact increase the risk of harm to the public.
G. THE ONE-SIZE-FITS-ALL APPROACH OF THE PROPOSED CGMP
LACKS SCIENTIFIC AND ECONOMIC MERIT
Dietary supplements are a diverse market. They include powders, tablets, gelcaps, and liquids. They include companies that do no more than extract powder from drums and insert that powder into capsules as well as companies that grow botanicals, harvest them, chemically treat and purify them, and mix them with other substances, such as vitamins and minerals. The varying forms and the varying natures of production each carry with them different levels of risk to consumers. Requiring companies that do no more than encapsulate dry nutrient powders to adhere to rigorous, all encompassing CGMPs makes little sense because the risk of harm to the public is minimal. Alternatively, requiring testing to determine identity and purity on herbs, botanicals and metabolites makes no sense in light of the fact that "[t]here are probably no available analytical procedures to establish the identity, purity, and potency of all . . . natural products" and the analytical techniques that could be used would be extraordinarily expensive. See Appendix D. In short, the "one-size-fits-all approach" of the proposed CGMPs is scientifically and technologically naïve. It is based on a faulty assumption that dietary supplements are, to a degree, fungible when they are extraordinarily diverse and are produced using vastly different techniques and methods of production. The "one-size-fits-all approach" imposes costs far in excess of what is justified for some companies, and it fails to take into account the known limits of existing testing technology. A methodology that better comports with consumer welfare is the existing case-by-case enforcement approach, taking into account the peculiar facts and circumstances of each situation and fashioning a remedy appropriate to the unique problems found.
THE PROPOSED CGMPs SUFFER FROM FATAL AMBIGUITIES
THAT PROVIDE INADEQUATE GUIDANCE TO
AGENCY INSPECTORS AND INVITE ARBITRARY AND CAPRICIOUS ENFORCEMENT
The proposed CGMPs are extremely vague (the logical result of attempting to apply one universal standard to an extraordinarily diverse range of products and manufacturing practices). Indeed, they are so vague that no two people reading them will likely come to a reasonably similar, let alone identical, interpretation as to how they apply to specific facts. Individual FDA inspectors will be left to decide what the vacuous language of the proposed CGMPs means and will, in the process, create a widely varying set of interpretations without the benefit of a single coherent regulatory framework. For example, consider the regulations in the Personnel, Plant and Grounds, and Sanitation of Buildings and Facilities sections of the CGMPs.
The first substantive provision of the CGMPs attempts to regulate the personnel hired by the manufacturer. Paragraph (a) attempts to exclude individuals with illnesses, open lesions, and infected wounds from the manufacturing process. The term "illness" is not defined and could arguably include individuals infected with the HIV virus or with cancer or other noncommunicable diseases (e.g., muscular dystrophy, lupus, etc.) who pose no threat of contamination. Nevertheless, a reasonable interpretation of paragraph (a) would make it incumbent upon such individuals to report their noncontagious ailments to a supervisor who must then determine whether to remove such persons from the production line. The reasonably foreseeable scenarios are fraught with potential violations to rights of privacy and the Americans with Disabilities Act that are unjustified.
Under Paragraph (b), an FDA inspector could deem an entire batch of dietary supplements to be adulterated upon finding a single violation that does not affect the entire batch. In addition, the issue of adequate cleanliness is one that draws FDA deeply into areas traditionally left to state and local health authorities. Thus, a conflict in the various jurisdictions is likely.
Paragraphs (c) and (d) attempt to require undefined, "adequate levels" of education, experience, and training necessary to perform a manufacturing job or supervisory function. Decisions related to adequate education, experience, and training are apparently left to the agency to decide on a case-by-case basis. Decisions will vary, of course, and no manufacturer will be able to know with a reasonable degree of certainty whether its existing employees will meet the undefined standard.
Paragraph (a) of the Plant and Grounds section of the proposed CGMPs informs manufacturers that it is necesarry for them to keep the gounds in a condition that will guard against adulteration. Subparagraphs (a)(1)-(4) invite individual FDA inspectors to determine whether grounds are being kept in a manner that minimizes the risk of contamination. Current agency inspectors lack professional degrees or training in environmental or industrial engineering and in industrial hygiene needed to exercise such judgment responsibly. Moreover, state and local officials also inspect the premises of the plants and may well have a different view concerning how grounds should be kept in order to minimize contamination. Moreover, local building and health codes as well as EPA and OSHA regulations dictate the operating systems for waste treatment. Adding another layer of regulation, via the FDA, would appear to be regulatory overkill and may cause FDA inspectors' judgments to conflict with local, state, and federal agencies. In other words, there are already sufficient regulations now in place without need for FDA entry. Regulation of the plant and grounds should be left to local, state, and other federal agencies that have an entrenched presence and developed regulatory expertise in this area.
Subparagraph (b) informs the manufacturer that the physical plant must be of suitable size, construction, and design to facilitate maintenance, cleaning and sanitary operations. Subparagraph (b) then lists a number of undefined factors that a manufacturer should consider when designing its physical plant. Apparently, the determination of whether a facility is adequate will depend on the judgments of FDA inspectors who are not currently expert in architectural or industrial engineering, environmental engineering, public health, public health law, or workplace safety or zoning law. Subparagraph (b) ignores the fact that state, local, and other federal agencies already have in place specific regulations concerning plant design. Indeed, at best requirements imposed pursuant to the proposed CGMPs would be duplicative of other regulations and, at worst, in conflict with them.
The FDA could not reasonably enforce the proposed CGMPs without hiring new staff (and training old staff) in industrial engineering, industrial hygiene, environmental engineering, public health, and federal, state, and local health and safety laws. Moreover, FDA would have to establish a permanent liaison office for coordination with local, state, and other federal agencies that have primary jurisdiction over plants and facilities to ensure proper harmonization of regulations-a costly and time consuming matter. The agency currently lacks the resources needed to perform those functions, and, in any event, current levels of safety in the market do not create a need for such extraordinary expenditures and efforts.
The section on sanitation of building and facilities is left largely undefined, thus inviting arbitrary and capricious enforcement. Paragraph (b)(1) attempts to restrict the toxic materials that may be stored at the plant. That provision is almost impossible to enforce because the manufacturer will be able to justify the storage of any toxic chemical on the basis that it is used in cleaning or sanitizing, laboratory procedures, maintenance, or plant operations. Moreover, other local, state, and federal agencies dictate primary regulation of those matters.
Because so many other federal and state agencies regulate in this area, it is not necessary (and constitutes regulatory overkill) for the FDA to expend resources to regulate the storage of chemicals in dietary supplement plants. Moreover, FDA entry into this field invites unnecessary conflict between entrenched regulators and the FDA.
Subparagraphs (e)-(h) attempt to regulate the plumbing, toilet, and hand washing facilities in dietary supplement plants. Once again, no definitions are provided, inviting arbitrary and capricious enforcement. The FDA is not charged with specific regulatory authority over facility design or industrial hygiene. Other federal, state, and local authorities are entrenched in this area and have developed regulatory expertise. There is thus no need for FDA entry into the field.
Subparagraph (j) states that supervision of overall plant sanitation shall be vested in a person qualified by education, experience, and training to perform the task. No definitions are provided. This section suffers from the same defects, noted above, as paragraphs (c) and (d) under the sanitation section.
Without greater definitional rigidity to give meaning to the language in the proposed CGMPs and without substantial revisions to avoid the distinct risk of arbitrary and capricious interpretations of the language used in the proposed CGMPs, arbitrary and capricious enforcement would appear inevitable.
THE AGENCY LACKS RESOURCES TO ENFORCE
THE PROPOSED CGMPs ADEQUATELY
To enforce the CGMPs would require an extraordinary effort by the FDA, one calling upon all of the agency's resources just to inspect every dietary supplement manufacturer's facilities with personnel qualified to evaluate each of the scientific and technical aspects of the CGMPs. Enforcement of the CGMPs requires expertise in biochemistry, toxicology, industrial and environmental engineering, public health law, employment law, and a host of other specialties. The agency would have to hire hundreds of such people to provide it with the sophistication needed to evaluate compliance with the CGMPs by regulatees. In the absence of resources sufficient to finance enforcement under the proposed CGMPs, the FDA must refrain from undertaking a burden it cannot afford.
THE PROPOSED CGMPs WILL NOT ALTER THE PRACTICES OF THOSE FEW WHO
CURRENTLY VIOLATE THE LAW BY PRODUCING ADULTERATED
AND MISBRANDED PRODUCTS
Those who will flout the law and sell misbranded and adulterated dietary supplements are unlikely to comply with the proposed CGMPs. Rather, the parties who will comply will likely be the very same companies who now assiduously avoid production of misbranded and adulterated dietary supplements. In short, rather than uplift the industry to higher levels of safety and quality, the regulation will merely ensnarl current law abiders (who do not pose a threat to safety and quality) in costly new regulations. In other words, the proposed CGMPs are unlikely to improve the market but rather merely add yet another layer of red tape for those who pose the least threat of harm and effect changes in industry structure and conduct that reduce consumer welfare.
THE DSHEA CREATES A PRESUMPTION IN FAVOR OF SAFETY
AND PRECLUDES ADOPTION OF PROCEDURES REQUIRING
MANUFACTURERS TO PROVE SAFETY IN THE ABSENCE OF EVIDENCE
In 1994, Congress passed the Dietary Supplement Health and Education Act. Under the Act, a dietary ingredient or supplement is deemed adulterated if it presents an unreasonable risk of illness or injury to the public. The Act, however, presumes that dietary ingredients marketed before October 15, 1994, are safe for their recommended use. 21 U.S.C. § 350(c). The Act permits the Secretary of Health and Human Services to declare that a dietary ingredient or supplement poses an imminent risk to public health and safety. 21 U.S.C. § 342(f)(1)(C). The Secretary, however, must immediately issue a formal rulemaking to affirm that declaration. Id. Moreover, the power to declare a dietary ingredient or supplement unsafe is a nondelegable function of the Secretary. Id.
DSHEA prohibits the sale of adulterated and unsafe dietary supplements. 21 U.S.C. § 331(u). The government, however, bears the burden of proving that a dietary ingredient is adulterated and unsafe. 21 U.S.C. § 342(f)(1). Prior to referring charges of adulteration to the United States Attorney, the FDA must provide the manufacturer with at least 10 days notice and an opportunity to present its view to the agency. 21 U.S.C. § 342(f)(2).
The FDA's proposed CGMPs would require the manufacturer, at the manufacturer's expense, to prove through scientific analysis that its dietary ingredients and supplements are safe whether or not they were commercially available in the United States prior to October 15, 1994. That proposal directly contravenes DSHEA's mandate that all dietary ingredients and supplements marketed prior to October 15, 1994, are presumed safe until declared otherwise by the Secretary of HHS, not the commissioner of FDA. Moreover, the Secretary's declaration must then be confirmed through a formal rulemaking. The FDA may not do through the CGMPs that which is contrary to provisions of the Act. Accordingly, FDA cannot issue any CGMPs that would require manufacturers to prove the safety of their dietary ingredients and supplements prior to marketing them commercially if they were available in the marketplace prior to October 15, 1994.
For the foregoing reasons, the Joint Commenters respectfully request that the FDA not adopt the proposed CGMPs and, instead, rely on existing law to stop adulteration and misbranding by the very few bad actors in the market who do pose a threat to public health. That approach will ensure an appropriate and meaningful
expenditure of agency resources without distorting the dietary supplement market's structure and conduct and without reducing consumer welfare.
PURE ENCAPSULATIONS, INC.;
DURK PEARSON and SANDY SHAW;
MINERAL RESOURCES INTERNATIONAL, INC.;
TRACE MINERALS RESEARCH, L.L.C.;
and AMERICAN NUTRITION CORPORATION,
Jonathan W. Emord, Esq.
Todd A. Harrison, Esq.
Claudia A. Lewis, Esq.
Emord & Associates, P.C.
1050 17th Street, N.W.
Washington, D.C. 20036
Dated: May 7, 1997
International Advocates for Health Freedom
POB 10632 Blacksburg VA 24062 USA