Tec Laboratories Inc. of Albany is working with the Food and Drug Administration to clear up labeling and approval issues for a product it has been marketing for several years.
The FDA sent a warning letter to Tec Labs this month concerning Staphaseptic First Aid Antiseptic/
Pain Relieving Gel, which it sells over the counter. The gel is used as a pain reliever for staph and the bacterial infection MRSA
(methicillin-resistant Staphylococcus aureos).
The FDA letters expressed concern that as it is currently labeled and formulated, the product does not meet provisions for over-the-counter sales.
In its letter the FDA says that Tec Labs’ labeling does not include all of the ingredients represented and also must be marketed as a “new drug” with an approved application.
“The FDA looked at a few products making MRSA claims and has indicated they should not be made available over the counter,” said Wendy Langley, regulatory affairs director at Tec Labs. “We’ve been working very closely with them to clear up the matter.”
Langley said the negotiations with the FDA may lead to some changes in labeling or how the product is distributed.
The letter, dated April 18, said Tec Labs had 15 working days after receiving the correspondence to comply. Langley indicated that the issue would be resolved within the deadline.
“We are confident that there will be a favorable outcome,” she said.
Tec Labs was founded in Albany in 1977 by chemical engineer Robert L. Smith. The company specializes in developing topical applications for skin infections and irritations.
It has been ranked by Oregon Business as one of the Top 100 companies to work for in the state 11 times and in 2005 received the “Excellence in Family Business Award” from the Austin Family Business Program at Oregon State University.
Tec Labs has 25 full-time employees.