The FDA wants pharmaceutical manufacturers to get some phthalates out of drugs and biologics.
The agency, in new draft guidelines, says producers should stop using dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP), because there is evidence they can cause reproductive and development problems in humans.
In new draft guidance, the FDA acknowledges evidence is still scanty, and that some compounds in the class are not toxic, but DBP and DEHP have been found to disrupt the endocrine system in lab animals. The notice points out that Europe has banned the two for use in cosmetics and that Congress has prohibited their use in children's toys.
"While it is recognized that drug products may carry inherent risks, DBP and DEHP are used as excipients, and safer alternatives are available," the FDA says in the recently posted document.
The agency makes clear that everything is covered in this guidance: drugs under development, over-the-counter drugs, currently approved drugs or those under review.
Manufacturers can find alternatives in the agency's Inactive Ingredients Database and need to determine if alternatives they plan to use have been used in approved drugs and at what level. The FDA gives the industry 90 days to file comments on the recommendation.