Big burden for tiny companies
A poster child for this issue has been Maine-based herbalist Deb Soule, who was quoted in a recent article in the Bangor Daily News about her struggles in bringing her small company, Avena Botanicals, up to FDA GMP standards. The issue is not one of safety, Soule claimed.
“Avena’s track record is impeccable. We really do our best to do no harm to anybody. That is really important to us,” Soule was quoted in the article as saying.
According to the article, Soule has spent more than $300,000 on new facilities and new personnel in an attempt to meet GMP requirements. Her company received a warning letter in November of 2014 that mentioned GMP failures, including lack of specifications and master manufacturing records. (The letter also took Avena to task for noncompliant disease claim language, which is a separate issue.)
Tailored GMP approach
Michael McGuffin, president of the American Herbal Products Association, is familiar with Soule’s situation, one mirrored by a number of very small companies within the industry. He said the herbalists operating these companies represent a kind of expertise that is not perfectly accounted for in the way FDA currently administers GMP compliance.
“Should a company like hers not have to comply with 21 CFR Part 111? I’m not going to make that argument,” McGuffin told NutraIngredients-USA. “The question before us, though, is that is there only one way to ensure the identity of the herbal ingredients she uses?
“She ‘receives’ her ingredients by harvesting the herbs in her garden. I don’t think it’s necessary to create a new regulatory category for companies like hers. But FDA needs a different approach to understanding how they need to implement GMPs and inspect compliance with the regulation for companies like hers. She is qualified by training and experience to identify these herbs, and there ought to be a way she can do that with proper documentation of how she does it,” he said.
Mark Blumenthal, founder and executive director of the American Botanical Council, agreed that there is a small subset of the industry for which GMP compliance might look very different than it would for a supplement manufacturer sending tens of thousands of bottles representing dozens of skus out the door every day.
“I am very sympathetic to people in her position for a variety of reasons. Some of them are herbalists with 20 or 30 years of experience. Many of them are experts in the area of field botany and identification. They are reliably going to be able to identify the herbs organoleptically and use them to make simple tinctures, salves and teas,” he said.
“FDA defines ‘small company’ as one that has less than 50 employees. Some of these companies might have only two or three,” Blumenthal said.
What’s best for the consumer?
A number of these companies distribute only locally, Blumenthal said, selling products directly at venues such as farmers’ markets or at most in very limited distribution in local health food stores.
“I’m also sympathetic to the intention of GMPs in which consumers can be assured that they are getting products whose ingredients were properly identified, that were made in sanitary conditions and that are properly labeled. Yet what happens is when GMP rules are applied to companies is this category the same way they would be to a big manufacturer with national distribution is that you create a burden that could really be impossible for a very small company to meet. Some of these companies really do make superior products, with the very freshest of ingredients. What’s in the best interest of the consumer?” Blumenthal said.
McGuffin said one change that could be made immediately that could ease the burden for these very small operators would be for FDA to adhere to the letter of the law and to figuratively put organoleptic identification modes on the same shelf as chemical tests.
“The regulation uses the word ‘organoleptic’ on purpose,” McGuffin said. “If I’m going to make a banana cream pie, I am qualified by training and experience to identify bananas in the produce aisle. I don’t need to do a chemical test on them.”