World Health Organization decides the gold standard of scientific evidence is superfluous

One of the biggest science and nutrition news stories — one that will have significant impact on the health of people worldwide — has received no international news coverage. The World Health Organization’s committee that establishes international food standards has changed its definition of “scientific evidence” used to support health claims for all foods and dietary supplements.

No longer will the criteria of scientific evidence for health claims need to be randomized controlled intervention trials on humans. The gold standard of clinical research is now considered outmoded.

Scientific evidence can now include “causal relationships” suggested in observational or epidemiological studies, animal and laboratory experiments, generally accepted authoritative information validated over time, and traditional knowledge and experiences of use. The acceptance of these alternative ways of knowing came after years of lobbying by the health foods and dietary supplement industry.

The Codex Committee on Nutrition and Foods for Special Dietary Uses met earlier this month in Cape Town, South Africa. Included on its agenda was to develop guidelines for the use of nutrition claims on food labels, establish standards for cereals for underweight infants and children, and draft revised recommendations on the “Scientific basis of health claims” to become part of the international Codex. To date, the criteria for substantiating health claims required well-designed, human intervention clinical trials.

For years, the Codex committee has been intensely lobbied — by the International Alliance of Dietary/Food Supplement Association (IADSA), the international non-governmental organization (NGO) representing 50 trade associations and over 20,000 companies in the dietary supplement industry, and the Council for Responsible Nutrition (CRN), the trade organization for manufacturers and suppliers of dietary supplements — to change these requirements. According to the IADSA in an August press release, “health claims based only on human intervention studies are not practical.”

“It is scientific dogma to state that health claims should be based primarily on well designed human intervention studies,” said Professor David Richardson, Scientific Adviser to the UK Council for Responsible Nutrition (CRN) and IADSA and with the International Life Sciences Institute (ILSI). “Much of what is already known about human health cannot be validated using ‘gold standard’ clinical trials.”

“Causal links cannot rely only on randomized controlled human intervention trials,” said IADSA chairman, Byron Johnson, “and each type of study can provide a different type of evidence.” They especially objected to these studies required for preventive health claims for reducing risks for diseases and pointed to health claims for fruits and vegetables and wholegrains which are based on observational studies, rather than clinical interventions. [“Claims” being the operative word here because, as we’ve seen, claims from observational epidemiological studies for vitamins, supplements and healthy eating for preventive health have failed to be supported in randomized clinical trials to date.]

They called on the Codex to focus on the totality of available data and give added weight to epidemiological/observational studies. David Pineda, Director of Regulatory Affairs for IADSA said in a press statement last year: “Scientific substantiation should involve a weighing of evidence taking into account the totality of the available data. This includes human studies, as well as observational and epidemiological studies.”

What is the Codex Alimentarius?

The Codex Alimentarius is the food code that’s become the global food standard for consumer foods, food producers and processors, national food regulatory agencies and international trade practices. The code has enormous impact and its influence extends to every continent.

The Codex Alimentarius Commission was created in 1963 by the UN Food and Agricultural Organization and the World Health Organization to develop the Codex, with its food standards, guidelines and codes of practice that protect human health and ensure fair trade practices. The Commission coordinates all of the food standards work done by international governmental and non-governmental organizations and makes recommendations for compliance regulations.

With the 1985 UN Resolution (39/248), the Codex became the guidelines for governments in developing and enforcing consumer protection policies around the world. Various international trade agreements in the global food market have also called for complying with the Codex. Its standards have also become the benchmarks against which food regulations are evaluated within the legal parameters WHO agreements. The reach of the Codex has changed, namely grown, over the years.

The Codex Alimentarius is not the only product of the Codex Alimentarius Commission. It scientific mission has become as influential. It establishes the scientific standards for food quality and safety, food production, labeling laws, food legislation and food regulations. Its scientific reviews and science-based efforts bring together experts and specialists from a wide range of disciplines “to ensure that its standards withstand the most rigorous scientific scrutiny.”

According to the WHO/FAO:

It is fair to say that the work of the Codex Alimentarius Commission, together with that of FAO and WHO in their supportive roles, has provided a focal point for food-related scientific research and investigation, and the Commission itself has become an important international medium for the exchange of scientific information about food…

The Codex Alimentarius has stimulated activity in the fields of food chemistry, food technology, food microbiology, mycology, and pesticide and veterinary drug residues. Much work is carried out in the form of collaborative studies among individual scientists, laboratories, institutes and universities and joint FAO/WHO expert committees and consultations. FAO and WHO expert meetings are independent of the Commission (and the Commission’s subsidiary bodies), although their output contributes significantly to the scientific credibility of the Commission’s work. The principle of ensuring the independence of scientific advice from practical realities of risk management has been followed by Codex from the earliest days.

Since 1995, the Commission has adopted various guiding principles surrounding the role of science in the Codex decision-making process and the consideration of other factors. The principles it said it has established in developing its scientific recommendations include excellence in scientific discussions based on best practices, independence of all experts who are not working on behalf of other interests, transparency of all activities and information, and universality and sharing of scientific data throughout the world.

“The credibility and acceptability of any conclusions and recommendations depend to a very large degree on the objectivity, scientific skill and overall competence of the members who formulate them,” states the WHO/FAO. “For this reason, great care is taken in the selection of experts invited to participate. Those selected must be pre-eminent in their specialty, have the highest respect of their scientific peers, and be impartial and indisputably objective in their judgment.”

The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) develops the provisions for all nutritional aspects of all foods, as well as develops the guidelines, general principles, and standards for foods made, marketed and sold for special dietary uses, that become part of the Codex. That’s why the November meeting to draft the guidelines for the use of nutrition claims and establish the scientific basis of health claims was so important.

The Draft Report

It appears the Codex Committee adopted the industry’s proposed language in its entirety. The Draft Report of the meeting and the agreed upon recommendations for the Codex was just posted and is expected to be adopted when the Codex Committee meets next year.

Africa, as the co-hosting country was allowed more delegates to participate. Ms. Barbara Hogan, Minister of Health of the Republic of South Africa, welcomed the Committee to Cape Town. As the Draft Report shared:

She said food insecurity, high rates of malnutrition and high food prices were big threats to consumers in Africa and that a lot of efforts had been made in South Africa to ensure equitable health services to all citizens and drew the attention of the delegates to the fact that participation in Codex work had helped South Africa to develop science based regulations that would help to reach this goal. She also informed the Committee that South Africa had implemented a successful food fortification programme. Ms Hogan acknowledged the challenges before the Committee to develop science based guidance for both developing and developed countries to ensure safe, good food for everyone and stressed the importance of the work on a scientific basis for health claims and also of new work on a Standard for Processed Cereal-Based Foods for Underweight Infants and Young Children and wished the delegates all the best in their deliberations.

According to the Draft Report, Section 3.2 “Criteria for the substantiation of health claims” and Section 3.3 “Consideration of the evidence” were amended and its new recommendations have been sent to the Codex. The "totality of evidence" was broadened to include observational studies, opinions and consensus statements of expert organizations; although it retained the statement that “health claims should be primarily based on evidence from well-designed intervention studies." (The word “clinical” was removed from the original.)

Evidence based on human studies should demonstrate a consistent association between the food or food constituent and the health effect, with little or no evidence to the contrary. Although a high quality of scientific evidence should always be maintained, substantiation may take into account specific situations and alternate processes, such as:

(a) ‘Nutrient function’ claims may be substantiated based on generally accepted authoritative statements by recognised expert scientific bodies that have been verified and validated over time.

(b) Some health claims, such as those involving a relationship between a food category and a health effect, may be substantiated based on observational evidence such as epidemiological studies… Evidence-based dietary guidelines and authoritative statements prepared or endorsed by an competent authoritative body and meeting the same high scientific standards may also be used.

The Draft Report also stated it “considered relevant substantiation for health claims are those addressing the relationship between the food or food constituent and the health effect.” As such, health outcomes aren’t required, but biomarkers (surrogate endpoints) may be used. Cause and effect relationships are established, according to the report, when the correlations are strong and biologically plausible.

Most telling was an added section that stated “competent national authorities can determine if, and under what circumstances, a claimed relationship is substantiated.” In an earlier draft, this had stated they must be government authorities, but the word ‘government’ was removed in the final version.

In other words, this gives an NGO, such as a health food or supplement industry organization, the ability to can make any claim it chooses and say it’s substantiated.

Few consumers will realize when they see a health claim on the label of a food or supplement, purportedly supported by scientific evidence from the WHO, that the definition for scientific evidence has changed.

Why has this story not been widely reported in mainstream media or in professional publications reaching the scientific and medical communities? It would appear the input of scientists and doctors in health policies is not wanted, as the WHO and UN-FAO become influenced by things other than the best science.

© 2008 Sandy Szwarc