Herbal Medicine

In New Self-Policing Effort, Herb 
Industry Urges, “Burn, Don’t Return”

By Erik Goldman, Editor in Chief

Leaders in the dietary supplement industry have a sharp new directive for manufacturers who discover adulterants or contaminants in botanical raw materials:Blumenthal SpeakingMark Blumenthal, Executive Director, American Botanical Council “Don’t Return It, Burn It.”

The innovative self-policing policy, launched in October, and supported by all the major herbal industry trade groups, is aimed at putting direct economic pressure on raw materials suppliers to improve the quality of the ingredients they sell into the US market.

“Don’t Return It, Burn It” is, essentially, a set of contract terms and standard operating procedures (SOPs) to be used by supplement brands in their raw materials purchasing agreements. The terms stipulate that if a manufacturer’s quality assurance officers detect “irreparably defective” raw materials, those materials are to be incinerated at the supplier’s expense.

Demanding Ingredient Integrity

Until now, executives at ethical supplement brands, or mislabeled raw materials faced difficult choices when they discovered contaminants or adulterants: they could choose to destroy the materials at their own expense and then replace them, or return the tainted product to the supplier for a refund or credit.

Given the duplicative costs of destroying and then re-purchasing fresh supply, most companies typically went with the latter option. This ensures that the defective ingredients won’t be used in that brand’s formulas. But the tainted stuff ends up somewhere, because suppliers typically re-sell the rejected material to someone. 

BAPP logo 2018 2line LOW21There are plenty of less-than-conscientious brands that either lack sufficient analytical testing to detect adulterants, or that choose to turn a blind eye toward substandard but discounted materials. It is no big secret that contaminated or mislabeled herbal products end up on retail shelves in the US.

Between 35-45% of the herbs found in the top-selling botanical categories sold in mainstream retail channels are potentially subject to contamination or intentional adulteration, estimated Mark Blumenthal, founder and executive director of the American Botanical Council (ABC). This does not mean these herbs are always adulterated. But it means that the risk is there.

Among the herbs most vulnerable to adulteration are: Goldenseal (Hydrastis canadensis), Saw Palmetto (Serenoa repens), Bilberry (Vaccinium myrtillis) and Black Cohosh (Actea/Cimifuga racemosa).

Blumenthal and his organization have been at the forefront of the fight to improve the quality of herbal ingredients since the 1970s.

The new campaign, developed collaboratively by representatives of the American Botanical Council, the American Herbal Pharmacopeia, and the National Center for Natural Products Research at the University of Mississippi, is a carefully-considered, systematic approach to ridding the supply chain of dirty or counterfeit raw materials.

“Burn It” is part of ABC’s ongoing Botanical Adulterants Prevention Program (BAPP). In recent years, the organization has published nearly 50 bulletins, lab guidance documents, and newsletters on matters related to botanical contamination and adulteration. All can be accessed free of charge.

ABC logoBlumenthal holds that the buyers of the raw materials—meaning the executives that run retail brands—hold the keys to ensuring quality throughout the supply chain. The buyer has the ethical responsibility to identify irreparably defective materials and to ensure that these do not enter the streams of commerce.

Defining “Defective”

The SOPs defined by “Burn It” support supplement brands in doing the right thing.

The program centers on the definition of “irreparably defective” raw material. The term signifies materials that “cannot be lawfully remediated by the supplier, the buyer, or any third party, for any use.”

This includes raw unprocessed herbal ingredients that contain environmental toxins, pesticide or herbicide residues, chemical or microbial contaminants, unlawful pharmaceutical ingredients, drug residues, illegal dyes, undisclosed fillers, or plant materials proven to be from species other than the desired and labeled species.

The proposed contract language was thoroughly vetted by seven prominent supplement industry attorneys, and subjected to scrutiny and feedback from industry stake-holders. Consequently, it has won strong initial buy-in from finished product brands and raw materials suppliers alike.

Fair to Both Sides

Michael Levin, a veteran supplement industry consultant, and one of the drafters of the Burn It campaign, says the program is “fair to both sides.”

Michael LevinMichael Levin, co-creator of "Burn It, Don't Return It" campaignIt is also in accord with federal regulations. “Under federal GMPs (Good Manufacturing Practices) a company cannot use non-conforming materials. But the GMPs and the regs are silent about what to do with what a company rejects,” said Levin at SupplySide West 2019, a raw materials trade show that draws attendees from all the major brands.

The purchase agreement language recommended by the “Burn It” campaign states that an ingredient supplier must agree a priori to the disposal of any and all raw materials found to be irreparably defective when tested according to Standard Operating Procedures by a 3rd party lab using validated and fit-for-purpose methods. Transport and destruction of the defective materials are at the supplier’s expense.

The terms do include provisions for dispute resolution with third party mediation, should a supplier disagree with the characterization of the materials in question. In this situation, additional analytical testing and legal costs are to be borne by the losing party.

Jim Emme, CEO of the popular NOW Foods brand, and its practitioner-focused Protocol for Life Balance subsidiary, said his company is whole-heartedly embracing this approach.

“We see it more frequently than we’d like,” Emme said, referring to problematic raw materials. “Oftentimes it’s just a mistake, the wrong ingredient was sent, or it was mislabeled. Most vendors are very cooperative about it. But what we’re talking about here is intentional adulteration, where someone tries to fool us.”

Facing an Ugly Truth

Economically motivated adulteration is one of the ugly realities of commerce. According to the US Pharmacopeia’s definition, it means the fraudulent addition of “non-authentic substances or removal or replacement of authentic substances without the purchaser’s knowledge, for economic gain of the seller.”

This is not only a supplement industry problem. It happens in the food, pharmaceutical, and building materials industries as well. Just about any business that depends on raw materials purchased from outside sources must be vigilant about it.

Emme echoed the belief that ultimately, it is up to finished product brands to detect and reject adulterated or poor-quality materials. He sees the new contract terms as a big step forward for supply chain integrity. NOW is one of a number of major brands that is all-in on “Burn It.” Pharmavite, another big player, is also onboard. So are many of the practitioner-only product lines such as Ortho Molecular products, Designs for Health, Metagenics, and Pure Encapsulations.

Informa, the worldwide media and conference production company that owns the SupplySide shows, as well as the massive Natural Products Expo East and West shows, has put its full support behind the initiative, says Jon Benninger, VP of Informa’s Health & Nutrition Network.

The ultimate success of “Don’t Return It, Burn It,” depends on the willingness of supplement brands to insist on its terms in all their purchasing contracts.

“The biggest piece of this will be education,” says NOW’s Jim Emme. “But I believe that most companies will comply. We’ll find out fairly quickly who’s willing to comply and who isn’t, who’s slippery and who’s not.”

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Webinar: Pediatric Immune System Support

By Erik Goldman

Ped Immune Webinar

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Many of our patients experience daily immune system challenges, and children are no exception!  Stress, busy school & extracurricular schedules, and erratic or poor eating habits can all impact the body’s natural defense mechanisms.

On top of that, there’s exposure in schools to a whole new host of germs.

Kids’ immune systems really have to ramp up for the fall! 

In this free webinar, Jaclyn Chasse, ND, Vice President of Medical Education at Emerson Ecologics, will look at the top ways we can support the immune health of pediatric patients as they move into the fall & winter seasons.

Dr. Chasse discusses:

  • The most common pediatric immune support questions Emerson's Ask the Experts hear most often from our clinical community (and our answers)
  • The Top 5 immune support products she recommends for children, both for long-term and short-term support (a.k.a. What every family should have in its medicine cabinet!)
  • How to make safe recommendations for children, including appropriate dosing guidelines
  • Other recommendations for holistic immune support, including dietary changes, lifestyle support, and at-home therapies

 

Sponsored By

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This webinar is for educational purposes and is not intended as medical advice or to diagnose or treat any health condition.

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Jaclyn Chasse, ND, is the Vice President of Medical Education & Wellevate at Emerson Ecologics, and a practicing naturopathic physician specializing in men's and women's reproductive health and infertility. She is a graduate of Bastyr University where she also holds an adjunct position, and has an undergraduate degree in biochemistry and molecular biology. She has co-authored several scientific journal articles in the field of medical biophysics and integrative medicine, and has been very involved throughout her career in improving healthcare access and education. Dr. Chasse is the immediate Past-President of the American Association of Naturopathic Physicians and the New Hampshire Association of Naturopathic Doctors.

Webinar: CBD for Anxiety & Depression--Case Studies & Clinical Pearls

By Erik Goldman

CV Sci Shunney Webinar

 

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Information about CBD (cannibidiol) and the endocannabinoid system is everywhere these days. So are claims about the health benefits of CBD. As compelling as these topics may be, the information presented is rarely clinically applicable.

What practitioners want--and need--is more information and guidance on how to use CBD safely and effectively in clinical practice.

In this free need-to-know primer, Aimée Shunney, ND, will share 3 case studies from her practice focusing on the use of CBD to increase stress resilience, reduce anxiety, and manage depression.

From these cases, she'll draw out key clinical pearls for patient care strategies, avoidance of drug interactions, selection of products, and more.

 

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Learning Objectives:

  • Learn about three patients’ successful experiences using CBD for depression and anxiety
  • Explore dosing strategies and practicalities of dosing titration
  • Review known issues with cannabinoid-drug interactions
  • Discuss challenges with extreme variation in products, including full spectrum products vs isolates
  • Learn various ways to balance the endocannabinoid system
  • Gain a clear understanding of how to choose superior products

Sponsored By

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Dr. Aimee Shunney HeadshotAimée Gould Shunney, ND, is a naturopathic physician in private practice since 2001, currently at Santa Cruz Integrative Medicine in Santa Cruz, CA. She combines western medical science with evidence-based natural therapies including diet, exercise, lifestyle coaching, nutritional supplements, herbal medicine, and bio-identical hormones. She specializes in women’s health and bio- identical hormone balancing as well as menopause, menstrual issues, sexual dysfunction, thyroid optimization, stress management, and digestive health.

Quality Assurance for Hemp CBD: Key Questions to Ask

By Erik Goldman, Editor in Chief

Quality assurance is a challenge for all herbal companies. For those making hemp extracts, the challenges are compounded by a confusing regulatory landscape, the inherent complexity of the plant, the surging consumer demand for CBD, and the entrance of dozens of upstart brands with no prior herbal experience and little understanding of basic QA methods.

Regulatory Confusion Reigns As FDA Grapples With CBD

By Erik Goldman, Editor in Chief

On July 30, former FDA Commissioner, Scott Gottlieb, published an op/ed in the Washington Post saying that the agency needs to get a grip on the "out of hand" CBD craze. But it's a tall order. In many ways, CBD epitomizes all the conflicting motives and scientific ambiguities with which the FDA must constantly contend.

A Guide to the Endocannabinoid System

By Jamie Corroon, ND, MPH & Jake Felice, ND

Interest in the medical use of phytocannabinoids from Cannabis Sativa L. (Cannabis) has reached an all-time high. These exogenous, plant-derived ligands interact with endogenously produced proteins, receptors, enzymes and endogenous ligands, in one of the most evolutionarily preserved biological systems known to the life sciences: the endogenous cannabinoid signaling system, better known as the endocannabinoid system (ECS).

Hemp & CBD: Evidence, Evangelism & Extreme Exuberance

By Erik Goldman, Editor

If you are confused about the therapeutic value of hemp oil, cannabidiol (CBD), and other cannabis-related substances, and you’re scratching your head trying to figure out what’s legal and what’s not, that’s good: It means you’re paying attention.  Yes, there is some evidence, but there's also a lot of evangelism. Clinicians face the challenge of separating the scientific realities from the hype. 

Cannabis: State of the Science

By Erik Goldman, Editor

Is there any solid science to support the use of phytocannabinoids in clinical practice? The answer is yes….and no.

It depends on how you define “cannabis” and “cannabinoids;” whether you’re talking about inhaled (ie, smoked or vaped), ingested, or sublingual delivery; and of course, which diseases you’re considering.