The Dietary Supplement Access and Awareness Act (HR 3156) was introduced at the end of June by Congresswoman Susan Davis. It does not relate to products containing only vitamins and/or minerals and, apart from a new section relating to unreasonable risk, is identical to another bill (HR 3377) introduced at the 2003 Congress.
The new section proposes the amendment of DHSEA's 'unreasonable risk' clause, establishing legislative authority for risk-benefit analysis, by specifying that even a small risk of serious adverse health effect be judged unreasonable in the absence of sufficient benefit and permitting the FDA to ban any dietary supplement even if there are uncertainties as to the levels at which it poses a risk.
According to AHPA, the section seems to be a direct response to a Utah court ruling in April that the FDA did not meet its burden of proof that ephedrine alkaloids present an unreasonable risk of illness or injury in doses of less than 10mg. The FDA is appealing the ruling.
"A risk analysis that does not consider the amount of the ingredient stands several hundreds of years of science on its head," said AHPA president Michael McGuffin.
He drew on the words of the 16th century alchemist and 'father of toxicology' Paracelsus, who said: "All substances are poisons; there is none which is not a poison. The right dose differentiates a poison."
"Ignoring the amount of an ingredient by legislative fiat makes for bad science and for bad law," said McGuffin.
AHPA opposed HR 3377 in 2003 because of key elements, which it said would impact herbal dietary supplement makers in several ways:
The bill would require companies to submit to FDA every six months a list of their products and product labels and, at the discretion of FDA, a quantitative listing of all ingredients.
McGuffin said the first time around that the idea of a product registration may deserve discussion and cost evaluation, but raised the question as to why this should be done more frequently by supplements makers than by drug companies.
It would also make submission of serious adverse event reports to FDA mandatory - something which AHPA is, in fact, in favor of for supplements.
But again, McGuffin said the bill compared unfavorably with parallel legislation for drugs, as drug companies are afforded protection for adverse effects reporting that, under the proposed legislation, supplement makers are not. This includes the provision that neither the submission of an adverse effects report nor any release of information about it is an admission of a causal relationship between the use of the drug and the adverse effect.