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Rockport herbalist struggles with FDA regulations

Posted Dec. 14, 2015, at 7:29 a.m.
Last modified Dec. 14, 2015, at 2:48 p.m.

ROCKPORT, Maine — This time of year, demand is high in the aisles of Royal River Natural Foods in Freeport for an echinacea and goldenseal compound that is great for colds and the flu, according to Becky Foster, the store’s supplement and body care manager.

But this flu season, customers seeking the remedy are out of luck. Deb Soule, founder of 30-year-old Rockport company Avena Botanicals, decided in late summer to temporarily halt the production of tinctures and compounds until Avena can complete the testing protocols required by the federal Food and Drug Administration.

“The road to compliance is long and expensive,” she wrote in a letter posted on her website. “We appreciate your patience and support as we navigate this complicated terrain.”

Foster, however, wants to be proactive. She said she and others from Royal River are trying to educate their customers about the regulatory situation that has been making business difficult for Avena Botanicals for several years. They also sent a letter to the office of Rep. Chellie Pingree, D-Maine, in an effort to get help with the regulatory crackdown.

“A lot of your local herbalists are not going to have the wherewithal to do the crazy things the FDA is asking them to do and survive,” Foster said. “This is a terrible thing that I don’t think a lot of people realize right now. It’s like a disbelief that this is happening. Our herbalist is doing everything right. She needs our support right now. She heals many, and we need to help her.”

Just a few years ago, Soule and her employees were primarily concerned with the business of growing herbs and handcrafting extracts, elixirs, salves and other products that are sold around the state and the country. Avena Botanicals’ gardens are certified organic and biodynamic, and signs on the access road encourage drivers to take care with butterflies, birds and the other living things on the property. In the growing season, the land blooms with more than 150 different medicinal herbs, flowers, trees and shrubs, Soule, a traditionally trained herbalist, said. In all her years of selling tinctures, salves and other herbal products, no one has gotten hurt, or sick, or died from their use.

“Avena’s track record is impeccable. We really do our best to do no harm to anybody. That is really important to us,” she said.

But the herbal industry is regulated under the same law as dietary supplements, and by 2010 all companies were required to be compliant with the FDA’s Current Good Manufacturing Practice regulations. Soule had taken big steps to get there, including moving her production out of an old farmhouse and building a $300,000 building in its place that is up to standard. Since 2010, Avena Botanicals has had three comprehensive inspections from the federal regulators, and Soule said she has been striving to build record-keeping and other systems that will get a pass from the agency.

Efforts to get comment from an FDA spokesperson were not immediately successful.

“It’s been challenging, and it’s been stressful, and it’s been financially really difficult,” Soule said of efforts to comply with the regulatory standards. “We had no place to start. The FDA tells you you have to do it. They don’t tell you how to do it. … I think herbal tinctures ought to be regulated as herbal tinctures. It’s wrong to lump us with dietary supplements. Vats of white powder are different than the liquid herbal extracts sitting on our shelves.”

Despite the push to comply with the standards, Avena Botanicals received a strongly worded warning letter from the FDA a year ago. The letter stated the company made therapeutic claims about several of its products that establish them as new drugs. One example given by the agency was Avena’s description that Willow Bark Liquid Extract “has a long history of use for easing pain and inflammation and reducing fever and headache.”

“We found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and its implementing regulations,” the district director of the New England District Office wrote in the warning letter. “Failure to promptly correct these violations may result in enforcement action, without further notice, including, without limitation, seizure and/or injunction.”

Since then, Soule has changed the descriptions of her products to what she can legally say: that her remedies support women’s health or a person’s immune system, for example. She also has had to hire a quality control consultant and has just hired a full-time quality control employee. It’s a lot. And when it came to the herbal compounds, she just decided to stop until she felt more confident about the company’s ability to comply with the required testing.

In addition to paying for the $300,000 new building, Avena Botanicals will need to come up with easily $100,000 per year to comply with the federal regulations — a lot for her company. To get there, Soule said they would need to increase sales by between 35 and 50 percent. The company also held a successful Kickstarter fundraising campaign to purchase equipment to help it with efficiency.

Soule said her company has never done any marketing, instead relying on word of mouth to let customers know about the products. She said she’s looking forward to changing that to find new customers and to tell the company’s story. And she doesn’t want to just give up and close up shop.

“This is a beautiful gem tucked into midcoast Maine,” she said. “In the new year, we will have another FDA inspection. Our prayer is that we will come through it as best as possible.”

Herbalists everywhere are spooked by the regulatory crackdown. Jovial King of Urban Moonshine in Burlington, Vermont, which faced many of the same issues as Avena Botanicals, decided to outsource production to a larger, certified organic manufacturer out of state, according to a November article in Seven Days, a Vermont newspaper.

Soule said she is hoping her compliance efforts, as expensive and exhaustive as they’ve been, will allow her to help other herbalists know what they should do and let her keep doing what she loves — making herbal remedies from the herbs she grows on her Rockport farm.

“I want to make sure the next generation of herbalists has a little bit of an easier time than I’ve had,” she said. “I want the next generation to be successful at helping people. I want people to have smaller scale, hand-crafted herbal remedies. We stop to say thank you to the plants we harvest. There’s a lot of joy and love, laughter and care, far beyond what is required of us.”

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