Department of Health and Human Services
Public Health Service
Food and Drug Administration
Docket No. 97N-0218
Consideration of Codex Alimentarius Standards
ACTION: Advance notice of proposed rulemaking.
62 FR 36243, July 7, 1997
DURK PEARSON AND SANDY SHAW
COMMENTERS Pearson and Shaw are scientists, maintaining residences in Nevada and California, who design dietary supplement formulations and license them to small manufacturing and retailing companies. They are authors of four books on aging and age-related diseases including the million plus copy #1 bestseller Life Extension, a Practical Scientific Approach (Warner Books, 1982). They have also published three other health books, two of which were bestsellers. Their fourth book, Freedom of Informed Choice: FDA vs. Nutrient Supplements, explained First Amendment free speech issues in relation to FDA regulation (prior restraints) of truthful, nonmisleading health claims for dietary supplements (for example, low dose aspirin and the reduction of risk of heart attack), focusing on the costs to the public health of such regulations and on alternative regulatory approaches.
1. In "IA, FDA's Policy Regarding International Standards," FDA says "...the agency's primary goal in participation in such standard-setting activities and use of resultant standards is to preserve and enhance its ability to accomplish FDA's public health mission, with the aim of enhancing regulatory effectiveness, providing more consumer protection with increasingly scarce government resources, and increasing worldwide consumer access to safe, effective, and high quality products."
COMMENT: Providing more consumer protection with increasingly scarce government resources cannot be interpreted to mean that the least expensive regulatory scheme to the FDA (eg., adopting the standards set by others) provides more consumer protection. The FDA is dealing with an increasingly information-rich environment. Attempting to reduce the complexity of this information by massive data deletion, eliminating of human variation by averaging, and oversimplification of current scientific understanding may be easy, it may be cheap, but it is not likely to enhance the public health. If the FDA does not have the resources to set standards itself, a quick and dirty "review" of internationally decreed standards by collecting public comments and "averaging" them (or, more likely, giving them arbitrary and capricious political weightings) is not a substitute. Such a process will result in a great public backlash against the FDA.
The FDA's most valuable, scarce, and fragile resource is legitimacy and public trust. If the FDA continues to lose this, large appropriations will not save the day. When the public looks upon the FDA's actions as politically motivated, arbitrary and capricious, and contrary to fact, FDA's health pronouncements will be widely ignored and scorned, and the FDA's credibility as a reliable source of health information lost.1
Also, in "IA, FDA's Policy Regarding International Standards," FDA notes that, in its Federal Register notice of Oct. 11, 1995 (60 FR 53078), FDA specified three considerations in the FDA's policy. Conspicuously absent from these considerations was FDA encouragement of the provision of more truthful and nonmisleading information so that consumers can make informed choices. This is part of the Congressional mandate on the FDA under NLEA and DSHEA and must be taken into consideration as part of FDA's overall response to Codex.
2. In IB, International Agreements, FDA says "The U.S. Government is a party to a number of international trade agreements. FDA has participated in a number of recent international trade negotiations to ensure that under such agreements, FDA regulatory practices can remain focused on fulfilling the agency's mission to protect the public health while being supportive of emerging, broader U.S. Government trade obligations and policies."
COMMENT: If U.S. companies wish to meet internationally set standards so as to be able to market such "standardized" products in countries other than the United States, they ought to be free to do so. But the products sold within the borders of the United States, as part of U.S. domestic trade, should not be required to meet international "standards." Any products meeting Codex standards should, however, be allowed freely to enter the United States to be offered for sale in the U.S. and ought also to be legal to manufacture in the United States.
Harmonization of regulations is worthwhile in an economic sense until the opportunity costs of foregone choices are greater than the savings due to diminished regulatory costs. In a rapidly growing information-rich field, such as the relation between nutrition and disease, one must carefully consider the regulatory costs of foregone choices. The consumer will ultimately make this decision; the FDA can attempt to interfere, but in the long run the consumer - not the U.S. government and not the FDA - is sovereign in a market driven constitutional republic.
3. In the last paragraph under IB, FDA says: "Thus, FDA's stated policy on international standards and the nation's obligations under the WTO provide compelling impetus for FDA to consider whether to revise its existing system for review and evaluation of international food standards, and if so, how such a revised system might be designed."
COMMENT: We believe that the FDA should not use its scarce resources to evaluate standards set by international bodies for the world at large which are not specific to the concerns of Americans and, which, at least in the case of dietary supplements, will result in even greater hostility toward the FDA and more legal actions taken against it. There are serious constitutional questions about the acceptance of standards set by an agency not a part of the U.S. government or employed by the U.S. government. This can be considered an unconstitutional redelegation of the authority delegated to the agency by Congress to set standards.2 At the very least, for each standard the FDA will have to conduct its own full investigation, not just accept the conclusions of "expert" international committees, which is likely to be very costly. Moreover, the international committees, unlike U.S. government rulemaking bodies, are not required to conform to, for example, the First Amendment, the Commerce Clause, open meeting laws (Federal Advisory Committee Act), and the Administrative Procedure Act, which are other reasons to challenge any purported authority they have to establish standards for the commerce of United States citizens.
4. COMMENT: In order to accept Codex standards, it would be necessary to change DSHEA. While Codex defines dietary supplements narrowly as vitamins and minerals, the DSHEA defines dietary supplements much more broadly to include, in addition to vitamins and minerals, botanicals, amino acids, metabolites, food constituents, and others. Some substances that are regulated as dietary supplements in the U.S. under DSHEA are regulated as drugs in some Codex countries (for example, DHEA, a natural cholesterol metabolite found in the human body). In the United States, it is also possible for a substance to be regulated as either a dietary supplement or a drug, depending upon whether it is intended to treat a disease (for example, beta carotene, when it is intended to treat xeroderma pigmentosum, is regulated as a drug). These are definitions and rules resulting from long political struggles in the United States to meet the desires of Americans. Neither the Codex nor the FDA can change the definition of dietary supplements in the DSHEA without Congressional passage of new authorizing legislation. As we (and, we believe, the majority of Supreme Court Justices) see it, a treaty cannot trump the United States Constitution, from which the federal government derives all of its authority. The federal government cannot legitimately give away the Constitutional rights of its citizens by treaty.
Major changes in DSHEA are not likely to pass this Congress; most current Members voted for DSHEA in the first place.
We propose, therefore, that companies wishing to export to countries requiring that their dietary supplements meet some international standard be free to meet that standard, but companies wishing to sell their dietary supplements within the United States not be required to meet these totally irrelevant (within the U.S.) standards.
5. COMMENT: "Under "IIB Role of Codex Standards Under the SPS and TBT Agreements of the WTO," FDA states that "The Conference also recommended that standards adopted include only those provisions necessary for consumer protection, particularly those related to health and food safety." As we and others have pointed out in other public comments to the FDA, there is a presumption of safety for foods and, under DSHEA, the FDA may not regulate dietary supplements more stringently than foods in common form. In fact, an analysis of risks shows that foods in common form are far more hazardous than dietary supplements. Food poisoning alone kills over 9,000 people every year in the U.S. This consideration should direct the allocation of FDA's scarce resources.
6. COMMENT: Under "IV. Request for Information. Part A," FDA requests responses to various questions. Part of the explanation of question #11 states that "...FDA believes that it will be faced with the following four situations with regard to standards that the agency believes to be suitable for FDA acceptance:" Situation #4 was given as: "(4) or the standard is not identical to or similar to any FDA regulation, and the adoption of the Codex standard is not subject to rulemaking under the act." We request FDA clarification as to how the FDA proposes to accept Codex standards without a rulemaking. We do not see how the FDA can avoid complying with the requirements of the Administrative Procedure Act, which provides the only way the general public can provide feedback to the agency concerning the regulations they must live with.
7. COMMENT: The last question given in this section ("IV. Request for Information. Part A") is: What goals, in addition to those listed previously, should be considered by the agency in developing any new regulations governing consideration of Codex standards? We believe that, in addition to the five other considerations FDA listed just before this question, there should be an additional consideration: (6) To ensure that the Codex standards do not conflict with the NLEA or DSHEA or the United States Constitution, including but not limited to the First Amendment protection of speech and press. We note here, for FDA consideration, that Justice Sandra Day O'Connor said, in an aside during a talk she gave that was televised on C-SPAN ("America and the Courts") on Sept. 27, 1997, that international agreements cannot take away property rights under the United States Constitution. We believe that the matter of the Constitutional limits on what the federal government can do through international agreements (eg. in expanding its powers under the Constitution or depriving its citizens of Constitutional rights) is about to become a major and highly contentious issue that will surely reach the Supreme Court.
8. COMMENT: Under "IV. Request for Information. Part B1," FDA proposes that, within an FDA notice of newly adopted Codex standards that FDA would publish in the Federal Register, FDA would describe the nature of the Codex standard, provide FDA's preliminary views on the standard, describe information the agency would need to evaluate the standard, invite public comment, and state the agency's preliminary plans to perform substantive review of the standard. We propose that FDA add the following to that information to be published in the Federal Register: (6) Identify conflicts with the NLEA, DSHEA, and the United States Constitution, including but not limited to the First Amendment protection of speech and press.
9. COMMENT: FDA asks, under "IV. Request for Information. Part B2, Enlisting Assistance of Expertise Outside of the FDA," what limitations there might be to the use by FDA of outside experts as part of an agency process established to review and evaluate Codex standards. One limitation would be that meetings of expert bodies working for the FDA would have to meet open meeting laws (the Federal Advisory Committee Act, FACA) and be open to the public. Some scientific experts may oppose this on the grounds that it will prevent "objectivity," that is, it would make transparent the wheeling and dealing and political tradeoffs that are an inherent and unavoidable part of any process, whether scientific or not, that is a part of political decisionmaking. However, since these decisions will affect hundreds of millions of people, there is simply no justification in an open society for making them behind closed doors. Indeed, FACA is the law, and legitimacy demands it.
10. COMMENT: FDA asks, under "IV. Request for Information. Part B3. Assessing Impact on Small Business," What issues, if any, would have a disproportionately large impact on small entities or would place small entities at a disadvantage relative to large entities? Regulations, in general, impose a greater impact upon small companies, simply because the cost of regulation must be paid out of a much smaller financial base. Thus, the FDA should consider the impact of enforced Codex standards upon the dietary supplement industry, which is comprised of (mostly) small businesses. This problem would be entirely avoided if the FDA follows our proposal given above, that American companies wishing to offer products in other countries would have to meet whatever standards exist in those countries, but that Codex standards would not be mandatory within the borders of the United States.
11. COMMENT: Under "IV. Request for Information. Part C. Maintenance of Public File of FDA Determinations Regarding Codex Standards," FDA asks for suggestions. We request that FDA put all such information on the Internet.
1 In the May 1995 FMI (Food Marketing Institute) survey, 45% of consumers trust no one and rely on themselves for assuring the nutritional value of the food they eat, up from 6% in 1994. Manufacturers followed at 23%, government 13%, food stores 5% and consumer groups 3%. A major shift has occurred at the expense of government, which led the list in 1990. In the 1995 survey, twice as many consumers reported looking to industry for assuring nutritious foods as the government. (as reported in Sloan and Stiedemann, "Guaranteed Success: How to Make Products Consumers Really Want," J. of Nutraceuticals, Functional & Medical Foods 1(1):69 (1997)
2 See AFL-CIO v. Occupational Safety and Health Administration, 965 F.2d 962, 984 (11th Cir. 1992), as discussed in Martin et al, "Environmental Law: Determination on Silica May Expose Flaw in Rule," The Nat'l Law Journal pp. B12-B14 (March 17, 1997). This article is attached as Exhibit 1.
Sept. 30, 1997
© Copyright 1999 by Durk Pearson & Sandy Shaw
NOTICE: The "Durk Pearson & Sandy Shaw Life Extension News" is for informational purposes only. Its contents are not intended as advice for the diagnosis, treatment, or cure of any medical condition. Pearson & Shaw are scientists, not doctors. If you have a medical condition, see a physician. Durk Pearson & Sandy Shaw® do not own any part of any dietary supplement company. They license their formulations and receive royalties on sales. The formulations they design and use are those which contain their names on the label. RETURN TO INDEX