Matrixx Initiatives Inc, which stopped selling its cold medicine Zicam on Tuesday, said it had 800 consumer complaints about the product but did not give it to regulators.
“We have complaints but we weren’t required to send them,” said William Hemelt, the company’s acting president and chief operating officer during a conference call with analysts, according to Bloomberg.
He said in the call that the U.S. Food and Drug Administration found the reports during a routine inspection in May. The FDA on Tuesday warned consumers they should stop using the company’s cold remedy nasal gel and related products because they could cause permanent damage to the sense of smell.
Hemelt said he was told by lawyers that current rules under a 2007 regulation requiring companies to turn in reports of serious side effects did not apply to the complaints the company had received, according to the report.
“At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”
The Zinc in the over-the-counter product may damage nerves needed for smelling, regulators said. The agency said 130 consumers had reported losing their sense of smell after using the products since 1999.
An FDA spokeswoman told Bloomberg on Tuesday that Matrixx was required to turn over the reports of side effects in line with a 2007 regulation.