NPA submitted comments on a proposed EPA rule under the the Resource Conservation and Recovery Act (RCRA). In the proposed rule, titled “Management Standards for Hazardous Waste Pharmaceuticals,” EPA includes dietary supplements within this definition apparently not because of what they are but because of where they are sold, in pharmacies and doctors offices, just as drugs are.
“The inclusion of dietary supplements in this rule represents a clear infringement of the federal statute governing dietary supplements, a complete disregard for Congressional intent, and an unfair targeting of the dietary supplement industry. This amounts to nothing more than government overreach and more red tape,” Daniel Fabricant, PhD, executive director and CEO of NPA, told NutraIngredients-USA.
Water pollution issue
The issue that EPA is seeking to address with the new rule is a serious one. For a number of years now researchers have been sounding alarms about the number of unused drugs that are improperly disposed of and which are finding their way into the water supply. According to the Harvard Medical School, while there has as yet been no demonstrated effect on human health from the presence of low levels of drug components in the water supply—either from improper disposal or from excretion—the effects on aquatic life are more clear.
“Numerous studies have shown that estrogen and chemicals that behave like it have a feminizing effect on male fish and can alter female-to-male ratios. Sources of estrogen include birth control pills and postmenopausal hormone treatments, as well as the estrogen that women produce naturally and excrete. Intersex fish — creatures with both male and female sex characteristics — have been found in heavily polluted sections of the Potomac River,” a Harvard statement says.
Derived from nature
The difference with supplements, Fabricant said, is that they do not contain such powerfully-acting and persistent chemicals such as estrogen. The vast majority of constituents of dietary supplements, such as vitamins, minerals, botanicals and others, are already found in nature.
“Most of these things are already have been in the soil or the water. These are nutrients that were found in the soil and made their way into plants,” Fabricant said.
Even naturally-occurring waste nutrients can present a problem if they are present in an overabundance in a given location. The disposal of the huge amount of waste from factory pig farms is an example. But Fabricant said that no such concentrated waste stream can be attributed to dietary supplements.
NPA argues that methods already exist for safely handling leftover supplements, in many cases returning them to the manufacturer where some of the components can be reconditioned for further use. Setting up a separate system under EPA would only serve to muddy the water, so to speak.
“As a matter of governance we can’t really two federal agencies (EPA and FDA) take two different approaches to the disposal issue,” Fabricant said. “If they were really concerned about too many vitamins and so forth finding their way into the environment, they should look at the amount of milk fortified with vitamin D that gets poured down the drain every day.”
To read the full text of NPA’s comments, click here.