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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 vs. 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, so what I do as a public health auditor is I make sure that the facilities are following the good manufacturing practice, the GMP. And what is GMP? It is a bit of an esoteric concept, but basically it is a concept in the Code of Federal Regulations, what we call the CFR. The CFR is the codification of final rules in the Federal Register. The Federal Register is often described as a legal newspaper of the executive branch of the federal government. It consists of 50 titles covering specific areas of federal regulations, and the rules administered by the FDA are written in Title 21, and the supplement GMPs are in Part 111.
So basically, I should start with explaining the GMP, but GMP ensures that the supplement manufacturer follows the recipe and the label claim information is verified. In other words, the product truly contains, say, 1,000 milligrams of omega-3. GMP does not address efficacy and potency in a pharmacological sense. So when the GMP auditors go into the facility, they look at to what extent the facility’s quality control is adequate, and if they follow the recipe, and if the label claim is accurate, as the packaging says.
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Kevin Pho: So in terms of GMP, otherwise known as 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. I would say it really depends on each facility. I should also mention that with the typical brand owners, when you look at the company’s name on the packaging, it does not necessarily mean that the brand owners are manufacturing those supplements at their facility. What happens is oftentimes they could outsource manufacturing to contract manufacturers. So we do not know if brand owners are really manufacturing, so the scope of responsibilities could be different.
So the GMP auditor’s job is also ensuring that the scope of responsibilities is defined for each party, because otherwise, when the adverse events happen, they need to do the recall, and they will need to have their responsibilities defined: to what extent it is the brand owner’s responsibility and to what extent it is the contract manufacturer’s responsibility.
Kevin Pho: So how can consumers differentiate between supplements that are produced in GMP-compliant facilities and those that are not? Are there specific labels they need to look for on the supplements? How can you tell the difference between something that is GMP-certified versus not?
Alisa Sano: So usually what you see is, on the back of the packaging, you will see the statement that says, “This supplement was manufactured at a GMP-compliant facility,” or something like that. So if you see that statement, then it means that those supplements were manufactured and probably packaged at a GMP-certified facility.
Kevin Pho: OK, and you talked to this a little bit earlier. What exactly goes into GMP certification? You mentioned auditors have to go in and make sure that the factory is producing supplements that contain what it says it contains. Go into a little bit more detail in terms of what exactly it takes for a supplement to be labeled compliant with GMP-certified practices.
Alisa Sano: Sure. So we start with ingredient picking and testing. Facilities must be picky with ingredient selection because basically what you put in is what you get out. So if the ingredient selection is not adequately controlled, the quality of the ingredients, and hence the supplement, suffers. So they need to have a system in place in the form of a supplier management or vetting program. This is often done by these contract manufacturers or brand owners auditing suppliers on-site, requiring them to fill out GMP surveys, reviewing the qualifications, and scrutinizing the certificates of analysis, which are essentially test reports of raw materials. GMP auditors evaluate the thoroughness of the supplier control procedure by reviewing documents and records for, say, initial qualification and requalification, and if they have an adequate supplier disqualification process, too, if they find any problems in their raw materials.
Once the facility selects ingredients, they perform identity testing for each ingredient, and this step is another crucial process because it verifies that the received ingredient is indeed the ingredient the supplier claims it to be. The identity testing procedure needs to be validated if you are using in-house or original methods, and it also needs to be fit for purpose. A one-size-fits-all approach does not work, especially when you’re handling botanicals or herbs. So you will always need to have a backup method that verifies the origin of the botanicals, making sure that the identity and all the chemical characteristics fit the already established specifications for the herbs.
Kevin Pho: Now, if I walk into a typical drugstore, approximately what percentage of supplements would be considered GMP-certified?
Alisa Sano: That is a good question. I do not know. I have no idea. What you can usually do is go on to the brand owner’s website, look up the supplements, and see if they have the GMP-certified list. Usually what they have is a GMP mark or any kinds of statements associated with the brand owners or contract manufacturers. So I would say the only way to make sure is to look at the back of the packaging or go to the website and see if they have those certifications listed.
What’s so fascinating is that to what extent they are certified is a huge issue right now, because we’ve recently had this survey on consumer drivers for online supplement shopping, and the survey revealed two interesting results. This survey was done on 500 U.S. consumers, asking about their concerns and expectations when purchasing dietary supplements online. The first result was that only 38 percent of online supplement buyers felt highly confident about the quality and safety of online supplements. So that ties into your question of what percentage of the retailers, I mean, of the contract manufacturers, have the GMP certification, right? This confidence level increased to 68 percent upon seeing an independent certification mark on the supplement package sold online, and 71 percent of respondents would switch brands if they found an equivalent supplement that had received independent certification. So if they have received those certifications, they can list that on their website or packaging, so that is basically the only way to verify if they are GMP-certified. The second result was that 51 percent of online consumers were willing to pay at least 10 to 15 percent more for independently tested and certified supplements, and 32 percent would pay 15 to 20 percent more.
So I think in general, we are moving in the right direction, in that retailer requirements and regulations are driving significant developments to enhance consumer safety and the quality of supplements. For example, this year, major online and brick-and-mortar retailers introduced new requirements for their sellers and now mandate specific quality testing and documentation for some supplement categories. We also have the Operation Supplement Safety, what we call the OPSS scorecard, and this was developed by the Department of Defense and is now used to evaluate the safety and quality of supplements. So while not all supplements are certified per the GMP yet, we are moving in the right direction in terms of the government regulations and also these retailers coming together to ensure the safety of supplements.
Kevin Pho: And who is doing the GMP certification? Is this a governmental agency?
Alisa Sano: So the FDA does have this regulation, and of course the FDA inspects facilities, but also, as an auditor, I belong to a third-party certification body. It’s an independent, internationally recognized public health organization, and I can’t disclose the name, but our institution was built in 1944. We are also ISO/IEC-accredited global laboratories, and we offer a wide range of testing, certification, and technical services, in addition to health risk assessments. We are comprised of auditors, engineers, microbiologists, toxicologists, chemists, and a lot of public health experts, and we provide services in 110 countries across all major industries.
Kevin Pho: So tell us what the risks are if someone purchases a supplement that is not GMP-certified. Do you have any real examples of risks or harms to patients because they purchased and consumed something that wasn’t GMP-certified?
Alisa Sano: Yes. So there are a lot of adverse events reported in the news. To give you an example, recently in Japan, we’ve had this huge recall that resulted in, I think, one hundred deaths and more adverse events. The supplement was linked to organ damage, such as kidney failure. I think the supplement was adulterated, and so it was not GMP-certified. I’m going to go into more details on different countries’ regulations later, but it was something to do with the lack of proper regulations, and it is a textbook example of the danger of consuming unregulated supplements.
Kevin Pho: So let’s talk about other countries. If someone purchases a supplement from another country, is GMP certification an international standard? Tell us about that.
Alisa Sano: The FDA’s GMP applies to the U.S. only, and so this is actually a very tricky issue. I audit the U.S. and also the APAC region, and having audited in the APAC region, I’ve learned that applying the same Code of Federal Regulations, the CFR standard, could be very difficult because the requirements could sometimes conflict with each country’s standard. For example, ingredient testing and label claim testing are required in the U.S. under the CFR, but not overseas, such as in Japan and New Zealand. Even the definition of dietary supplements versus food is different in these countries.
But if you are purchasing supplements in the U.S., all the supplements coming into the U.S. need to be cleared with the GMP to some extent. I mean, not all, which is why it’s so tricky. You will need to be very careful when you are purchasing supplements that were manufactured outside the U.S., because technically they do not fall under the FDA regulation. But I would assume that these companies or facilities will have to be registered with the U.S. FDA if they’re exporting to the U.S. But again, since each country has different regulations, it is a little tricky.
Kevin Pho: So I get questions all the time in my exam room about the safety of supplements. Patients give me internet information: “Is this supplement safe?” So tell me the type of advice that I can give patients whenever they ask me about the safety of supplements and what they should be looking for.
Alisa Sano: Yes. So I would say not all supplements are created equal, and I need to emphasize this all the time, because just because you go into the grocery store and see all the supplements on the supplement aisle, you cannot just assume that all supplements are safe. So I would encourage patients to do their homework and try to look for the GMP statement. Usually, as I said, you can find one on the package saying something like, “This product was manufactured in a GMP-compliant facility.” Alternatively, if you don’t see that, you can still look up the brand owner’s or company’s website and learn about their safety measures or list of certifications.
Kevin Pho: So from a company standpoint, I’m going to assume that the reason some of them don’t comply with GMP certification is because of the cost, right? It’s probably more expensive for them to do so. Is that the main reason?
Alisa Sano: I would say so. I mean, there could be multiple reasons, but yes, in a way, clearing this GMP means investing in the quality of the facility. The quality control department needs to be robust. They need to be doing ingredient testing, valid ingredient testing, which means that they will need to send samples to contract laboratories if they do not have in-house labs, so that will add up to the cost. Also, for all the equipment, utensils, and machines, you will need to be able to have a preventive maintenance program that makes sure that all the equipment is functioning properly, and all the sanitation and cleaning procedures need to be in place. So of course, the facility and company need to invest initially in the quality control system, but I would say that it’s a long-term investment that will actually help the facility gain the consumer trust.
Kevin Pho: And just to be clear, when something is GMP-certified, it only speaks to the sourcing and that the ingredients inside the supplement are what they say they are. It says nothing about the efficacy or potential drug interactions of the supplement. Is that correct?
Alisa Sano: Correct. GMP does not cover efficacy or potency of supplements. It just covers the safety, I mean, and label claim information.
Kevin Pho: We’re talking to Alisa Sano. She’s a public health auditor. Today’s KevinMD article is “GMP vs. non-GMP: the hidden truth about your supplements.” Alisa, as always, let’s end with some of your take-home messages for the KevinMD audience.
Alisa Sano: I’ll be repeating myself, sure, but not all supplements are created equal, and we need to empower health care providers and patients, or health consumers, by increasing health literacy regarding supplements, and especially the concept of good manufacturing practice, GMP, because this will help them make guided 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.
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