AUSTIN, TX—Cordyceps is widely regarded as one of the most valuable ingredients in traditional Chinese medicine (TCM). The fungus is harvested from the wild and consists of a club-shaped, spore-releasing fruiting body that emerges from a ghost moth (Hepialus spp.) larva. Recently, the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) announced the publication of its first document focused solely on a fungal ingredient, the Botanical Adulteration Prevention Bulletin (BAPB) on cordyceps (Ophiocordyceps sinensis), documenting the many ways in which the fruiting body and mycelium of the fungus are mislabeled and/or adulterated.

About the Cordyceps Market

Cordyceps refers to several different fungal species, but Ophiocordyceps sinensis is the primary species that grows in the wild. Predominantly sold in the natural channel of retail trade, cordyceps dietary supplements support kidney, immune, and cardiovascular health, improve athletic performance, and increase endurance. Last year, cordyceps was the 26th top-selling herbal supplement ingredient with $5,225,915 in sales.

ABC reports that, due to the high costs associated with wild cordyceps, its dietary and food supplement market is dominated by lower-cost alternatives, commercially raised Cordyceps militaris or Paecilomyces hepiali (reclassified as Samsoniella hepiali in 2020). In Asia, wild cordyceps are sold at high prices with undeclared additions of pieces of sticks or wires and are soaked in concentrated mineral solutions to increase the weight. In Europe and the U.S., financially motivated adulterants in cordyceps dietary supplements include different fungal species (e.g., Tolypocladium inflatum), grain-based media containing small amounts or no cordyceps mycelium, undeclared excipients or fillers.

The Report

Authored by renowned herbalist, botanist, mycologist, and author, Christopher Hobbs, Ph.D., President and Executive Director of the nonprofit American Herbal Pharmacopoeia (AHP) Roy Upton, and Chief Science Officer of the nonprofit American Botanical Council (ABC) Stefan Gafner, Ph.D., the bulletin includes a review of the available literature on cordyceps adulteration, nomenclature and taxonomy, supply chain/network and market importance, and analytical approaches to detect adulterants and was peer-reviewed by 21 experts from academia, contract analytical laboratories, and the botanical ingredient industries in the United States and internationally. 

“This has been a challenging bulletin to write…especially figuring out what is currently offered as ‘cordyceps’ in various regions around the globe. For me, the main takeaway for the dietary supplement industry is that better methods to authenticate the various products marketed as cordyceps are needed,” shared Dr. Gafner.

The bulletin on cordyceps marks the 29th publication in the series of BAPBs and the 91st peer-reviewed document published by BAPP. “I hope that our publication will help consumers, manufacturers, practitioners, and researchers understand the origins and biology of these fascinating traditional medicines, along with considerations of the design and conduction of further studies to help define the potential efficacy and range of health benefits of these traditional products as well as how to produce them in the most efficacious way,” shared Hobbs.

A full copy of the report is available from BAPP and ABC.

Related:  DSHEA at 30: Trade Group View

2023 Person of the Year: Mark Blumenthal, American Botanical Council

20 Herbs & Fungi Requiring Extra Scrutiny

Vinpocetine, bacopa, citicoline, and lycopodium are some examples of pharmaceutical drugs detected.

These ingredients, being regulated as pharmaceutical drugs in South Korea, cannot be used in food supplements, said South Korea’s Ministry of Food and Drug Safety (MFDS).

Elsewhere, however, these ingredients could be used as both pharmaceutical drugs or for use in supplements.

Vinpocetine is one such example.

While it is used for treating stroke and dementia​, it is also available in certain markets as a dietary supplement to enhance cognition and memory.

The MFDS, on the other hand, has raised concerns on how vinpocetine was known for causing side effects such as headaches, insomnia, miscarriage, or foetal development disorders when overdosed without a professional prescription. 

“These ingredients are either prescription drug ingredients that require a doctor’s prescription or ingredients that cannot be used as food ingredients,”​ said the MFDS.

These cases came to light when the MFDS was conducting an inspection of health supplements sold online.

The inspection covered 3,629 products, with information on the product name, manufacturer, presence of hazardous ingredients, and product photos placed under scrutiny.

The aim was to detect the presence of ingredients that fall in the List of Hazardous Foods for Overseas Direct Purchase.

As a result, 19 supplements were found to contain ingredients found in the list.

The MFDS has since requested the Korea Customs Services to withhold customs clearance for these supplements.

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We sit down with Alisa Sano, a public health auditor, to explore the world of dietary supplements and the critical role Good Manufacturing Practices (GMP) play in ensuring product safety and quality. Alisa sheds light on the hidden details behind supplement labels, how consumers can make informed choices, and the importance of GMP certification in protecting public health. If you’ve ever wondered how to tell the difference between safe and risky supplements, this conversation is for you.

Alisa Sano is a public health auditor.

She discusses the KevinMD article, “GMP vs. non-GMP: the hidden truth about your supplements.”

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. Today, we welcome back Alisa Sano. She’s a public health auditor. Today’s KevinMD article is “GMP versus Non-GMP: The Hidden Truth About Your Supplements.” Alisa, welcome back.

Alisa Sano: Thanks for having me.

Kevin Pho: So you are a public health auditor. What exactly is that?

Alisa Sano: So, public health auditor … I work in the dietary supplements industry. What I do as a public health auditor is make sure that the facilities are following good manufacturing practice, or GMP.

Kevin Pho: And what is GMP?

Alisa Sano: It’s a bit of an esoteric concept, but basically, it’s a concept in the Code of Federal Regulations, OK? What we call CFR. The CFR is the codification of final rules in the Federal Register, which is often described as a kind of legal newspaper for the executive branch of the federal government. It consists of 50 titles covering specific areas of federal regulations. The rules administered by the FDA are written in Title 21, and GMPs are in Part 111.

So, I should start by explaining that GMP ensures the supplement manufacturer follows the recipe and verifies the label claim information. In other words, it ensures that the product truly contains, say, a thousand milligrams of omega-3. GMP does not address efficacy and potency in a pharmacological sense.

When GMP auditors go into a facility, they look at the extent to which the facility’s quality control is adequate—if they follow the recipe, and if the label claim is accurate as the packaging says.

Kevin Pho: So in terms of GMP, or good manufacturing practices, do most of the supplements that we find in a typical drugstore fall under that umbrella?

Alisa Sano: That’s a good question, and it’s very tricky. It really depends on each facility. I should also mention that a typical brand owner—when you see a company’s name on the packaging—it doesn’t necessarily mean the brand owners are manufacturing those supplements at their facility. Often, they outsource manufacturing to contract manufacturers. We don’t always know if brand owners are manufacturing. So, the scope of responsibilities could be different.

The GMP auditor’s job includes ensuring that each party’s responsibilities are defined. When adverse events happen, they need to do a recall, and responsibilities must be defined—whether it’s the brand owner’s responsibility or the contract manufacturer’s responsibility.

Kevin Pho: So how can consumers differentiate between supplements that are produced in GMP-compliant facilities and those that aren’t? Are there specific labels to look for on the supplements? How can you tell the difference?

Alisa Sano: Usually, on the back of the packaging, you’ll see a statement that says, “This supplement was manufactured in a GMP-compliant facility,” or something similar. If you see that, it means the supplement was manufactured and probably packaged in a GMP-certified facility.

Kevin Pho: OK. And you touched on this a bit earlier. What exactly goes into GMP certification? You mentioned auditors have to go in and ensure that the factory is producing supplements that contain what the label claims. Can you go into a bit more detail about what it takes for a supplement to be labeled as GMP-certified?

Alisa Sano: Sure. We start with ingredient selection and testing. Facilities must be picky with ingredient selection because what you put in is what you get out. If ingredient selection isn’t controlled, the quality of supplements suffers. They need a system in place for supplier management or a vetting program, often done by contract manufacturers or brand owners auditing suppliers, requiring GMP surveys, and reviewing qualifications and certificates of analysis, which are test reports of raw materials.

GMP auditors evaluate the thoroughness of the supplier control procedure by reviewing documents and records for initial qualification, requalification, and disqualification processes if there are problems in raw materials. Once the facility selects ingredients, they perform identity testing for each ingredient. This verifies that the received ingredient is indeed what the supplier claims it to be.

The identity testing procedure needs to be validated, especially if using in-house methods, and it must fit the purpose. One-size-fits-all doesn’t work, especially for botanicals or herbs. There should be a backup method to verify the origin of botanicals and ensure the identity and chemical characteristics match the established specifications.

Kevin Pho: If I walk into a typical drugstore, approximately what percentage of supplements would be considered GMP-certified?

Alisa Sano: That’s a good question. I don’t know the exact percentage. Usually, you can go to the brand owner’s website and look up the supplement to see if they have a GMP certification list. They might have a GMP mark or a related statement from the brand owner or contract manufacturer. The best way to verify is to look at the back of the packaging or check the website.

A recent survey of 500 U.S. consumers asked about their concerns and expectations when buying dietary supplements online. Only 38 percent of online supplement buyers felt confident about the quality and safety of online supplements. That ties into your question about what percentage of contract manufacturers are GMP-certified.

This confidence level increased to 68 percent when buyers saw an independent certification mark on the supplement packaging. Seventy-one percent of respondents said they would switch brands if they found an equivalent supplement with independent certification.

Kevin Pho: And who is doing the GMP certification? Is it a governmental agency?

Alisa Sano: The FDA has regulations and inspects facilities, but as an auditor, I work for a third-party certification body. It’s an independent, internationally recognized public health organization founded in 1944. Our institution is also ISO-accredited, offering testing, certification, technical services, and health risk assessments with a team of auditors, engineers, microbiologists, toxicologists, chemists, and public health experts in over 110 countries.

Kevin Pho: What are the risks if someone purchases a supplement that isn’t GMP-certified? Do you have any real examples of risks or harms to patients?

Alisa Sano: Yes. There are many adverse events reported in the news. For example, in Japan, there was a huge recall that led to about 100 deaths and more adverse events. The supplement was linked to organ damage, kidney failure, and it wasn’t GMP-certified. It’s a textbook example of the danger of consuming unregulated supplements.

Kevin Pho: So let’s talk about other countries. If someone buys a supplement from another country, is GMP certification an international standard?

Alisa Sano: The FDA’s GMP applies only in the U.S. This is tricky because I audit both the U.S. and APAC regions, and applying the CFR standard can be difficult as requirements can conflict with each country’s standards. For example, ingredient and label claim testing is required in the U.S. but not in Japan or New Zealand. Also, the definition of dietary supplements differs between countries. However, supplements entering the U.S. need to be GMP-compliant to some extent.

Kevin Pho: I often get questions from patients about the safety of supplements. What advice can I give patients when they ask about supplement safety?

Alisa Sano: Not all supplements are created equal. Just because you see them on the store shelf doesn’t mean they’re safe. I encourage patients to look for a GMP statement on the package or check the brand’s website for safety measures or certifications.

Kevin Pho: I assume the main reason some companies don’t comply with GMP certification is cost?

Alisa Sano: Yes, investing in quality control adds up. Facilities need robust quality control departments, testing, and equipment. It’s a long-term investment that helps facilities build consumer trust.

Kevin Pho: And just to clarify, when something is GMP-certified, it only verifies the ingredients. It doesn’t speak to the efficacy or potential drug interactions, right?

Alisa Sano: Correct. GMP doesn’t cover efficacy or potency; it only covers safety and label claim information.

Kevin Pho: We’re talking to Alisa Sano, a public health auditor. Today’s KevinMD article is “GMP versus Non-GMP: The Hidden Truth About Your Supplements.” Alisa, as always, we’ll end with your take-home messages for the KevinMD audience.

Alisa Sano: I’ll repeat myself—not all supplements are created equal. We need to empower health care providers and consumers by increasing health literacy regarding GMP. This will help people make informed decisions when choosing supplements.

Kevin Pho: Alisa, thank you so much for sharing your perspective and insight. Thanks again for coming back on the show.

Alisa Sano: Thank you so much, Kevin.