Avena Botanicals herbalist Deb Soule made the announcement in a blog post on the company’s website on Friday, saying Avena was “ecstatic” to have FDA compliance after “months of determined work.”
Late last year, Soule told the BDN that the company had been working hard to comply with the FDA’s manufacturing regulations and had moved production out of an old farmhouse and into a new $300,000 facility.
Avena, which Soule founded 30 years ago, make tinctures, salves, extracts and other herbal products from medicinal herbs, flowers, trees and shrubs grown in Rockport. Products are sold around the state and the country, but the herbalist said in 2015 that FDA compliance efforts were slowing business down. She decided late last summer to halt the production of tinctures and compounds until the company could complete the required testing protocols.
In some ways, Avena’s problems with the FDA began in 2010, when the federal agency required all herbal industry producers, no matter how small, to be compliant with regulations known as Current Good Manufacturing Practices.
Compliance proved expensive, Soule said. In addition to the $300,000 building, she estimated the company would need to come up with at least $100,000 per year to comply.
Some of Avena’s supporters reached out to U.S. Rep. Chellie Pingree, D-Maine, in an effort to help the company navigate the road to regulation.
This winter, Pingree, who sits on the House Committee on Appropriations, told the BDN that she “definitely wanted” to have a conversation with the FDA about Avena’s regulatory problems.
“This is such a big category. It’s regulating things that are powdered and in pill form and sold in massive quantities, regulated the exact same way” as herbal remedies produced in small quantities, she said. “Avena has never had a problem with safety in 30 years of business. Here’s a nice Maine company with 10 employees, selling a product that’s in demand. The regulations shouldn’t be so stringent that they’re cost-prohibitive.”
Efforts to reach Avena were not immediately successful Friday.