(c) 1998 by Durk Pearson & Sandy Shaw
Comparison of food safety to nutrient supplement safety
by Durk Pearson
There is a statutory presumption of safety for foods. Historically, this presumption of safety has applied to nutrient supplements, which have been regulated as foods. The FDA now proposes to shift the burden of proof on harm from the FDA to nutrient supplement manufacturers in this rulemaking procedure. The FDA's proposal to require nutrient supplements to meet the far stricter safety standards of food additives or drugs reflects the FDA's assumption that nutrient supplements are less safe than foods. However, the evidence indicates otherwise.
The worst public health problem associated with a nutrient supplement involved the development of a serious disorder, eosinophilia-myalgia (EMS), in association with the ingestion of supplements containing the essential amino acid tryptophan. As a result of EMS, 38 Americans died and about 1,500 others became sick. The U.S. Centers for Disease Control (CDC), the government agency whose mission is to identify the causes of epidemics, investigated the cause of EMS and published their final report in which they identified contamination in batches of tryptophan from one manufacturer as the cause of the tryptophan supplement associated EMS.1,2 No other nutrient supplement has been involved in such a disaster. As a result of the EMS incident, the FDA proposes to regulate amino acids and many other nutrient supplements, including high potency vitamins, as unapproved drugs or as unapproved food additives. The tryptophan-associated EMS is the linchpin of the FDA's case for stricter regulation of nutrient supplements. However, the risks of contaminated foods are even greater than that of the contaminated tryptophan.
Risk of Contaminated Tryptophan
The U.S. Centers for Disease Control estimated that 15,000,000 Americans were using tryptophan supplements at the time of the EMS incident which killed 38 people.1 This results in a death rate of 2.5 deaths per million users for 1989, the year in which nearly all of the contamination occurred. (If the deaths are averaged over the 25 years that tryptophan has been used as a nutrient supplement, the death rate per user per year is, of course, far lower.)
Risk of Contaminated Food
There are many types of potentially lethal food contaminants. For the sake of brevity, let us consider only one type, listeriosis, caused by the pathogenic bacterial contaminant Listeria monocytogenes. Listeriosis alone causes about 450 deaths and about 100 fetal deaths every year in America.3 There are about 260,000,000 food users in America, so the death rate among American food users from listeriosis alone is about 2.1 per million per year, and this occurs every year -- not once in a quarter century. Some foods are more likely to be contaminated with this bacterium than others. For example, those who eat soft cheese are about 2.6 times as likely to become infected with listeriosis than those who do not.4 This means that the listeriosis death rate is about 5.4 per million soft cheese eaters each and every year. Compare this to the death rate of 2.5 per million tryptophan supplement users which occurred once during a quarter century period of tryptophan supplement use.
Note, too, that there are many other deaths from other lethal food contaminants each year. For example, the deaths from contaminated undercooked hamburger in the Western U.S. earlier this year were caused by a toxin producing an E. coli bacterial strain. Salmonella, from undercooked eggs and poultry, is also extremely common.
It is not necessary to ban tryptophan supplements to prevent a repetition of the EMS incident, any more than it is necessary to ban soft cheese. It is not even necessary (though it is desirable) to identify which of several contaminants was (or were) responsible for the EMS. L-tryptophan has been manufactured by companies using processes that have been shown to be safe by many years of historical experience. Just as the FDA has developed Good Manufacturing Practices for foods, the FDA should do the same for nutrient supplements. One requirement ought to be that a nutrient manufacturer must provide an HPLC analysis of each batch of a nutrient. Each batch of tryptophan, for example, should be analyzed by HPLC, so that any contaminant peaks in the batch that were not present (or are present in greater amounts than) in historically safe batches can be readily determined. The safety procedures and assurances incorporated into Good Manufacturing Practices would be safeguards against the poor manufacturing practices that led to the production of the contaminated tryptophan that caused EMS.
In 1989, the year of the contaminated tryptophan EMS epidemic, a tryptophan supplement user had a lower risk of death from EMS than a soft cheese user's risk of death from listeriosis from contaminated soft cheese. Even the worst case supplement problem, EMS from contaminated L-tryptophan over a roughly one year period after a quarter century of safe use, caused a lower death rate per million tryptophan supplement users in that year than the annual year after year death rate per million users of soft cheese from listeriosis contamination alone. The FDA's proposal to require nutrient supplements to meet a much stricter safety standard than common foods makes no sense. The Agency is misallocating far too much of its limited resources to the regulation of nutrient supplements, when the risks of common foods are greater.
1) Belongia, et al, "An Investigation of the Cause of the Eosinophilia-Myalgia Syndrome Associated with Tryptophan Use," The New England Journal of Medicine, 323:357-365 (9 August, 1990)
2) Kamb, et al, "Eosinophilia-Myalgia Syndrome or Fibromyalgia with Eosinophilia - A Reply," Journal of the American Medical Association, 269:3108-3109 (23/30 June, 1993)
3) Gellin, et al, "Listeriosis," Journal of the American Medical Association, 261:1313-1321 (3 March, 1989)
4) Schuchat, et al, "Role of Foods in Sporadic Listeriosis: 1: Case-Control Study of Dietary Risk Factors," Journal of the American Medical Association, 267:2041-2045 (1992)
© 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.