The Food and Drug Administration (FDA) recently closed its public comment period on its proposed Guidance for Industry: Evidence-Based Review System for the Evaluation of Health Claims.  FDA's guidance documents, including this Guidance, do not establish legally enforceable responsibilities but rather describe the Agency's current thinking on a topic.

The American Association for Health Freedom (AAHF), in association with its international affiliate, the Alliance for Natural Health, recognizes that this draft guidance was issued in part due to requirements placed on the FDA by the Pearson v. Shalala Court of Appeals decision. In that case, the plaintiffs (including AAHF, formerly the American Preventive Medical Association) challenged the FDA's decision to not authorize health claims for four specific substance/disease relationships for dietary supplements. Although the district court ruled for FDA (14 F. Supp. 2d 10 (D.D.C. 1998)), the U.S. Court of Appeals for the DC Circuit reversed the lower court's decision (164 F.3d 650 (DC Cir. 1999)). The appeals court held that the First Amendment does not permit FDA to reject health claims that the Agency determines to be potentially misleading unless the agency also reasonably determines that a disclaimer would not eliminate the potential deception. The appeals court also held that the Administrative Procedure Act required FDA to clarify the SSA standard for authorizing health claims.

As one of the plaintiffs in Pearson v. Shalala, AAHF takes serious issue with the manner by which the FDA seeks to satisfy its constitutional obligations of specificity by issuing this Guidance. According to AAHF Executive Director, Brenna Hill, "By universally subjecting health claims to an evidence-based system with a disproportionate emphasis on human clinical trials, we foresee grave consequences for the health care community and the population at large."

The Guidance provides all the hallmarks of a system that will phase out the structure/function claim environment that has been so important to consumer choice and which has been allowed under the Dietary Supplement Health and Education Act (DSHEA) since 1994. Furthermore, the Guidance places the burden firmly on clinical trials or human observational studies and ascribes no value to clinical experience, medical records, in vitro studies or animal studies. This regime will ultimately favor large corporations and Big Pharma which are the only parties with sufficient money to undertake randomized controlled trials (RCTs). Smaller companies, who have been the life blood and pioneering force in the rapidly expanding, consumer-driven natural health market, will be left out in the cold.

Though the stated rationale for the FDA's proposed Health Claims Guidance seems progressive and innocuous enough (i.e. "Armed with more scientifically based information about the likely health benefits of the foods and dietary supplements they purchase, consumers can make a tangible difference in their own long-term health by lowering their risk of numerous chronic diseases"), a closer examination of the document suggests that its ultimate effects would be the compromise of scientific rigor in the investigation of health claims, the exclusion of the small producers from the testing process by means of financial barriers, and, above all, preventing consumer access to vital, life-preserving information which will allow them to manage their own health using natural, rather than pharmaceutical products.

AAHF's and ANH's response to the FDA highlighted observations and concerns to the Guidance as well as recommendations. They highlight the following:

* Clear definition by FDA of significant scientific agreement (SSA) in the evaluation of health claims (i.e. proposed substance/disease relationships) was ordered by the US Court of Appeals in 1999.
* FDA has responded by proposing that human studies, with particular weight given to randomized controlled trials (RCTs, also "intervention studies"), be treated as the primary criteria upon which to officially validate a health claim.
* This requirement rejects methods that in the past have been vital in the development of structure/function claims including in vitro studies on human cells, animal studies, biochemical studies, observational studies and epidemiological studies. It also stands to obscure the extant wealth of knowledge on foods and supplements derived from veterinary science and decades of clinical practice.
* Wherein the experimental design of RCTs produces the most compelling evidence in pharmacological studies, its methods are seldom practical or even ethical in studies of foods or dietary supplements with regard to human health. Given context, RCTs have been demonstrated in several respects to be on equal footing or even inferior to alternate methods of research.
* Execution of thorough human studies, particularly of RCTs, is well outside the financial scope of small producers, the entities that most commonly pioneer 'health foods' and introduce novel health foods and supplements to the market.
* Although FDA naturally and reasonably expects the health claims brought before it to comprise "a continuum of scientific evidence that extends from very limited or inconclusive evidence to consensus, with evidence supporting SSA health claims lying closer to consensus," it has made no indication of how it will transmit information regarding the source, strength or relevance of its scientific evidence to the public with regard to a health claim decision. Given that the 1999 case ruling derived in large part from the Court's desire for increased transparency from FDA, this issue demands immediate attention.

AAHF and ANH submitted a powerful critique of the US Food & Drug Administration's (FDA) proposal for evaluation of health claims and asked that the FDA overhaul its proposed Health Claims Guidelines, taking into account all credible research done on foods and nutritional supplements, paying special attention to the extensive knowledge base derived from veterinary science practices in the formulation of nutritional supplements. Furthermore, they urged the FDA to assemble an independent panel of specialists from the nutritional, biochemical, consumer and health care arenas to which appeals can be made regarding health claims.

The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization serving as the politically active voice at federal and state levels to protect Americans' rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislature and crafting legislation; acting as a government watchdog and filing comments on proposed rulings; educating the public, press, and decision-makers on integrative medicine; initiating legal activities and joining and forming significant coalitions.

AAHF has partnered with our international affiliate, the Alliance for Natural Health (ANH) in drafting comprehensive and critical comments on the FDA Guidance. The ANH is a UK-based, internationally-active, non-governmental organization working to positively shape the regulatory and scientific frameworks affecting natural health. As an alliance, the ANH brings together scientists, medical doctors, integrative practitioners, lawyers and consumers as well as suppliers of food and dietary supplements globally as a means of working towards the development of sustainable approaches to healthcare. The ANH has been extensively involved in inputs to European Member State governments, the European Commission and the European Food Safety Authority (EFSA) with regard to the EU Nutrition & Health Claims Regulation which came into force across Europe on 1 July 2007

The AAHF and ANH are deeply concerned that the tone of the FDA Guidance document suggests a move by the FDA towards classic orthodox medicinal models, which will dispense of the framework that has led so many Americans towards taking responsibility for their own health.