Niche ought to be carved out of GMP compliance picture for ultra small herb companies, experts say

By Hank Schultz

- Last updated on GMT

Related tags Herb Herbalism

Niche ought to be carved out of GMP compliance picture for ultra small herb companies, experts say
A place ought to be found within the regulation of the dietary supplement sector for artisanal herbal companies that might struggle with some of FDA’s more labyrinthine strictures on identity testing, experts say.

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.”

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It is a plan!

Posted by Siandra,

The trouble is that a) most so-called government regulators have never had any regulatory training at all b) standardization is getting more and more detailed and geared to big companies in an aim to kill the remaining small businesses such as these. More sensible regulators would ensure that these small businesses-the backbone of society as we know it-meet a minimal standard geared to hygiene and documentation practices period. Elaborate commercial standards should be reserved for big companies, never for small artisans businesses distributing only locally or very small-scale.

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Compliance w/ Less Excuses

Posted by Ingredient Identity,

Failing to plan effectively is what we see most often regardless of the company size when we are putting together an optimal regulatory strategy for them. A failure to effectively research, strategize and budget as one should with any business and market that they are in, and evaluate what options exist, including compliance experts/partners and other options to ensure compliance with the applicable GMP requirements that oh by the way, have been in place for nearly 9 years now, doesn't warrant a sympathy vote. Spending in excess of $300K to "meet gmp requirements" means any number of things, but we've seen quality/compliance programs rolled out from scratch for less than a quarter of that figure following a Warning Letter being issued, often is much less than even that if done properly. BTW - There's more to that figure that should be understood by the readers. The easiest thing to manage/control that gets people into trouble the quickest is the marketing and labeling compliance aspects of a finished product, which costs typically only a few hundred dollars to a few thousand to be compliant, so not having basic record keeping logs or procedures is a whole other level be concerned about. The regulations hold small companies just as they do large companies equally accountable. No one would want a small building or home to be less safe or less up to code before they buy it or move it because there is some regulatory exception compared to a bigger home or sky scraper, right?...we want the same level of safety standards in place across the board. To that effect and in relation to the other comments, many of the companies that caused the most harm in this industry with mislabeling, adulterated products or other blatant non-compliance issues have fewer than 50 employees, in fact, they have fewer than 5. So is that really relevant? We don't think so.

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21 CFR 111 failed to protect very small business despite laws in place requiring it.

Posted by Robert Kavanaugh,

This article really hits the mark for me personally, and I even wrote a letter during the regulatory comments period years ago pointing out exactly this weakness, as did hundreds of other interested parties. Obviously, our concerns were ultimately disregarded, even as the final regulation s release was delayed by years. You'll note that FSMA does have the protections in place for very small businesses. Perhaps the cGMP portion of DSHEA should include the same protective provision for very small businesses, which were supposedly mandated by other federal statues anyway.

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