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Mar. 30, 2000 (Washington) -- Despite dietary supplement makers' past complaints about FDA activism, these makers of "natural" substitutes for prescription drugs may themselves be responsible for the eventual birth of stricter rules with regards to how dietary supplements are promoted to pregnant women.
In an attempt to calm a growing outcry by health care professionals against the promotion of dietary supplements to pregnant women, two of the larger trade groups said Thursday they would submit to stricter regulations under a compromise deal. The announcement was made at a public hearing called by the FDA after health care professionals expressed strong objections to provisions in an agency rule that allowed supplement makers to promote these products for morning sickness and swelling of the legs related to pregnancy.
The final question might come down to what the FDA can accomplish legally. The rule was meant to outline what claims can and cannot be made by supplement makers under a 1994 law passed by Congress. The law was aimed at restricting what the FDA can regulate with regards to dietary supplements.
Under that law, makers of dietary supplements cannot claim to mitigate, treat, prevent, cure, or diagnose disease. Therefore, the symptoms associated with pregnancy would have to be considered symptoms of disease before the FDA could restrict what claims could be made.
The Council for Responsible Nutrition (CRN) is a trade association that represents about 100 dietary supplement makers. " CRN recognizes an increased need for prudence when dealing with products intended for use by pregnant or nursing women," said Annette Dickinson, PhD, CRN's vice president of scientific and regulatory affairs.
But while pregnancy is a controversial issue, "We feel strongly about the fact that the uniqueness of pregnancy labeling should not erode the support for the current regulations," said William Soller, MD, senior vice president of Consumer Healthcare Products Association (CHPA). CHPA is a 119-year-old trade organization representing more than 200 dietary supplement and over-the-counter drug makers.
Some dietary supplements such as folic acid do offer a distinct benefit, and a compromise could be struck for those products that do not, Soller said. For example, he said, products that do not offer a distinct benefit, but may still be used by pregnant women, could be required to say: "If you are pregnant or nursing a baby, ask a health professional [prior to using the product]." Most of CHPA's members already are using this statement, and CHPA intends to soon petition the FDA to require this statement by regulation, he said.
"I think it is a step in the right direction," said Allen Mitchell, MD, director of the Slone Epidemiology Unit at Boston University and one of several health care professionals that came to speak out against the existing pregnancy provisions. But there is still the question of what bar will be set for products that make pregnancy claims, and why products need to be specifically promoted to pregnant women at all.
"Women cannot be expected to know when their symptoms have crossed the line from normal discomfort into a disease state," said Donald Mattison, MD, medical director of the March of Dimes, who along with several other consumer groups came to urge for repeal of the current provisions.
As of now, there is also no time frame for when the FDA might make changes to the current rules. The purpose of this meeting was to gather information, says Joe Levitt, JD, director of the FDA's Center for Food Safety and Nutrition. The FDA has yet to discuss or decide what it may do, he tells WebMD.