Industry leaders discuss botanical adulteration in the supplement industry.
The Participants Are:
• Rupa Das, Vice President of Global Quality and Compliance, BI Nutraceuticals, Long Beach, CA, (310) 669-2100
• Daniel Fabricant, PhD, CEO, Natural Products Association, Washington, DC, (800) 966-6632
• Gabriel Giancaspro, PhD, Vice President, Foods, Dietary Supplements and Herbal Medicines, U.S. Pharmacopeia, Rockville, MD, (800) 227-8772
• Frank Jaksch, Founder and CEO, ChromaDex, Inc., Irvine, CA, (949) 419-0288
Herbal products are under scrutiny like never before. Nutrition Industry Executive asked experts in the field their opinions on the state of botanical adulteration, and how the issue can best be tackled.
NIE: The New York attorney general (NY AG) recently tested five herbal supplements from major retailers, and stated the products did not include any of the herbs listed on their labels. How is this news story affecting the industry, and will its stick with consumers?
Fabricant: It affects the industry on a few levels. The first is sales, and I don’t think this affected sales. That’s probably good news. The second is, does this mean we’re going to have 49 other states looking at this? The answer is possibly. The third area is, what’s this going to do to affect us on a federal level? Are we going to have the introduction of legislation that cites this sort of thing, and I would say probably to that. Those are the lasting effects. The newspaper cycle is giving this a lot of oxygen, which is concerning. Science doesn’t always work in sound bites. The meticulousness of DNA testing doesn’t make headlines. What is going to make headlines is, “Hey, we tested these products and they didn’t have what we expected to find based on DNA.”
Jaksch: It seems to have had a significant impact on the industry, in some ways more so than the announcement of FDA (U.S. Food and Drug Association) GMPs (good manufacturing practices). As an independent third party testing laboratory, as well as regulatory and GMP consulting services, we have seen a significant increase in business since the story broke. This action has forced some companies to take a serious look at the quality and GMP compliance of their products. As long as the NY AG continues to pursue this, we expect that it will continue to drive further reflection.
Yes, I think it will stick, especially if the NY AG keeps initiating new action, as he has over the past couple of weeks.
Das: The news story is definitely getting a lot of attention and consuming a lot of time and effort by the industry to respond to it. The story will have an effect on consumer purchases, however, most consumers will still go by what works or does not work for them. The industry is pretty well regulated currently, but not all players play by the rules.
Giancaspro: This obviously has a major impact on the industry. There are many industry members very concerned with quality that invest in systems to ensure quality and compliance with current GMPs. For them, assurances are already in place, but the story is a reminder that looking for savings in quality matters implies a risk in doing business, including risk of litigation. We may suspect that other manufacturers would like to take advantage of the DSHEA (Dietary Supplement Health and Education Act of 1994) loopholes. For this other kind of manufacturers, nothing is changing until the regulation is changed. It is interesting to note that the AG has chosen to analyze store brands rather than specialty brands. Is there a perception of saving in quality to reduce price?
Trade associations and other media are amplifying the discussion with many repercussions. It is hard to say how long this would last. Fortunately, this story is not about dead or sickened people. It remains to be seen how general attorneys in other states respond to the way shown by NY. Should this cascade to other states, the story will continue to run.
NIE: Should the supplement industry consider more regulation to combat “Wild West” accusations and eroding consumer confidence?
Fabricant: Is there something the industry should do to address declining consumer confidence? On a Federal level, I wouldn’t worry about consumer confidence. We have to worry about people in congressional office. What are they thinking? That’s where it starts. If you’re not a member of a trade association you should be, obviously, preferably ours. Participate in political campaigns, PACS. You should participate in grass roots efforts, like we’ve done. Get the word out. Let congress know, I’m a consumer I vote, and as part of my livelihood, this is how I help keep my community health. Let’s consider all the facts and all the facts appropriately.
To help restore consumer trust, would you suggest something such as requiring third party GMP testing? I don’t think you can require it. But yes, of course that’s a good idea. The industry wants quality products too. What are the stepping-stones toward taking the industry to a higher, ever-evolving quality? Also providing a clear understanding of what regulatory agencies require.
This is a political issue; it isn’t a scientific issue. I used to regulate supplements for the government, I can tell you as a matter of fact, this is a political issue and we have to engage politically. It has much less to do with the actual quality of products in terms of what the industry needs, but how the industry is perceived. That’s the action of trade associations and advocacy groups. I don’t know if there’s a direct way to hit it, but I can tell you we’ve been successful by getting thousands of emails and tweets up to the attorney generals office, and that’s been important. I think if the science was all the way there, transparent, in a peer reviewed and published in a prestigious journal, but considering that it’s not, we’ll look and see what remains. And what remains is the politics of the issue and grabbing headlines. We have to show our industry is not interested in that, and is not going to be supportive of that.
These ideas don’t stay in one place. It may spread to other states. This should be concerning to any industry, not just to natural product retailers but to all retailers, telling them what they can and cannot sell based on incomplete data. That’s concerning. If it happens in this industry, there’s not an industry it can’t happen to.
Jaksch: Two things to consider here. One is that the FDA has implemented GMPs for dietary supplements, so the industry already has the appropriate framework for regulation in place, therefore no new for more regulation. With that being said, having a regulatory framework in place and enforcing that regulation are two different things. So if we all agree that the FDA GMPs already in place are in fact suitable, then we need to get the FDA the resources (money/budget) it needs to do its job, and enforce the rules. My opinion is that the FDA division of dietary supplements needs to be carved out as its own division and receive a separate budget, as well as an appropriate budget to fully enforce the regulations.
The second thing to consider is “self-regulation” meaning that the market should maintain its own market surveillance, by routinely pulling products off the shelf and testing these products for compliance. This entire attitude in the media about the market being “Wild West” or “unregulated” has been going on for as long as I have been in the market, over 15 years now, and I think that “unregulated” sentiment carries over to consumers, including some regular dietary supplement users, which I think is now supported with survey data. What does that mean, well to me it is very simple, whatever message the market is sending is not being heard, so time for a change. A message of self-regulation initiative would send a strong message to the world that the market is willing to take a hard and critical look at itself.
Giancaspro: Third-party verification programs are not part of the current regulation. Rather, they are already an available choice for manufacturers and store brands. Manufacturers may promote a more relevant role of these programs within the regulations as another way to keep control rather than concede this role to government agencies. Yet, another way to avoid this accusations is to make transparent what are the standards being followed. USP (United States Pharmacopeia) public specifications can help; should these manufacturers or store brands have claimed compliance with USP specifications, the AG would have known what standards to test against and what analytical procedures to use. Since USP standards are internationally recognized, this approach would have an additional advantage to those exporting dietary supplements outside of the United States, since it brings a component of international harmonization. Would these manufacturers start to see DNA barcoding used by other countries to detain U.S. exports?
NIE: How have GMPs affected botanical adulteration?
Jaksch: In my opinion, they haven’t really affected it very much, as evidenced by the continued flow of 483’s and warning letters coming from the FDA related to failure to perform appropriate “identity” testing of ingredients, such as botanicals, a trend that would continue to grow with increased enforcement. Don’t get me wrong I think that there has been significant improvement since the FDA GMPs were put into place, but that was more than seven years ago now, and there are still plenty of failures in setting simple specifications and identity testing.
Das: The GMPs are forcing companies to identify the genus and species of the product they are selling.
Giancaspro: GMP requires identity testing for all incoming dietary ingredients in 100 percent of batches used for the manufacturing of dietary supplements. However, GMPs gave to manufacturers the power to decide what test to use. Unless the manufacturers claim compliance with a public standard such as USP, there is no way to know what quality specifications the products are subject to. Moreover, two products labeled in the same way but produced by different manufacturers are likely to be subject to a different set of specifications with the consequent lack of consistency in quality of dietary supplements containing the same ingredients. This will not happen if both products claim compliance with USP or if USP is mandated as the standard for all dietary supplements.
NIE: More than a year ago, the FDA reported to the industry that 60 percent was not in compliance with GMPs. Has that improved?
Fabricant: I haven’t seen the recent numbers, so whatever they are we can revisit the issue. There were some concerns early on with meeting GMPs, and the agency has done a good job creating a deterrent, and actively going against cases that have no interest in GMP compliance.
NIE: What are suppliers and manufacturers doing to address the issue of botanical adulteration? What are the biggest challenges?
Jaksch: Some are simply not doing enough, if anything at all, and that really needs to change. Quality is expensive, but it can also be managed. If some of these companies would have started the process, even at a slow pace seven years ago, it would have made implementation costs much more manageable. Fixing these problems in damage control mode is much more expensive.
Das: Suppliers and manufacturers are doing more testing and partnering with reliable supply chain. Their biggest challenges in this area include:
• Lack of standard testing methodology for ID
For example, a certain product may test ID positive by FTIR (Fourier Transform Infrared Spectroscopy), but ID negative by a different method. Not all labs are equipped to do all types of ID tests. In most cases, several different types of ID tests are required to correctly identify the product. Lack of standardized methodology also leads to different results from different labs.
• Lack of proper standards
Chemical constituents of the plants are impacted by weather. Therefore, the standard being used may have been impacted differently than the sample, and will produce different results. In case of extracts, the extraction process may be different from one factory to another. This difference in process will affect the ID profile of the product. Therefore, if the standard was produced under conditions different from the sample, ID profiles of the standard and the sample will be different.
Giancaspro: The market laws of price, demand and competition drive the industry. In order to stay in business, they must maximize the return and save costs. Responsible manufacturers will not save in quality costs at the risk being forced out of business. The biggest challenge will be to invest in quality keeping the competitiveness and consumer access to quality dietary supplements at reasonable price.
NIE: What kind of investment is needed by manufacturers to not only avoid adulteration, but also produce a quality botanical product?
Jaksch: Quality is done right, comes at a cost, but as I said before, the costs can be managed, but that would require a change in the way many of these companies do business. The quality control/quality assurance costs will essentially be the same, whether you are running 1,000 bottles or 100,000 bottles the costs will not be that much different, but when you run 100,000 bottles that costs start to become a rounding error. Quality is not simply a matter of testing ingredients and products; it goes way beyond that. It goes into the entire process of supply chain management and business practices. Manufacturers need to qualify vendors and part of purchasing practices, including physical audits and inspections, as well as sign formal contracts or agreements with these vendors defining the expectations under the relationship. You cannot “test quality” into a product, it needs to be manufactured properly first.
Das: If the manufacturer has to test every incoming material per spec, it would be a huge investment, whether they have an in-house lab or use third party testing labs. However, if their supplier has the testing capability in place, manufacturers do not have to test all the parameters for every incoming material. They can qualify their supplier and validate the supplier COA on a periodic basis. This will reduce testing duplication and cost.
Giancaspro: Analytical equipment, laboratory personnel, quality systems (quality assurance), supply chain control, third party verification programs.
NIE: How has detection of adulterants improved?
Jaksch: Sure, there have been some advances in analytical testing technology and I think that there are some new advances with techniques, such as NMR, that have been around for a long time, but advancement in software and data analysis have changed the game, but more on that later, as we are not quite there yet, but getting closer.
There is no “best” testing methodology. In reality, there is no single analytical test method available that will work for everything, unless someone of course invents the Star Trek tricorder, but until then we will need to work with what we have available. Testing botanicals can be challenging but not insurmountable. In reality, because of the complexity of botanicals, an “orthogonal” approach must be employed, which means sometime more than one analytical method is necessary to really confirm identity.
Das: Sensitivity of testing methodology has vastly improved over the years, and has led to better detection of adulterants. Depending on what form the product is received in (dried powder, extract, blend) the ID testing methodology will be different. In most cases, more than one technique may be required to confirm ID.
Giancaspro: The vast majority of adulteration of dietary supplements with drugs occurs with known adulterants. It is easier than ever to know what to test for using a targeted approach. Libraries of analytical data of known adulterants help with the detection using targeted approach. For a non-targeted approach, recent advances in chemometrics made easier to detect a material that presents variations with respect to a set of what is typically expected for that material.
It would be very difficult, and even inappropriate, to say what works best in every case. In many cases, simple methodologies of handheld equipment like Raman or NIR may work fine for an initial screening in real time. Microscopy is an inexpensive way to look for adulteration, but requires specialized operators. Further confirmation may require more sophisticated methodologies like different types of spectrometers (NMR and MS) and chromatographic procedures. Perhaps, the most universal equipment to analyze a sample suspected of adulteration is the HPLC-MS.
NIE: Where can industry members get training or other assistance on avoiding adulteration and testing methodology?
Jaksch: There have been training program and seminars discussing the topic of botanical identity testing going on in this industry as long as I have been actively involved, which is more than 15 years now. There are many great resources available such as NPA, AHP, USP, AHPA, AOAC, NIH-ODS, NIST, the list goes on … not to mention several very good laboratories and consulting businesses than can help navigate this process. If you look hard enough, you will find a lot of published material available to address many of these issues.
Das: There are several industry organizations, such as AHPA, ABC, AHP and USP, that are working on adulteration issues. There is a lot of information available on their websites. Also, there are training sessions offered by these organizations, as well as thirdparty testing labs, to help the industry in these matters.
Giancaspro: There are numerous organizations offering basic training on the use of specific methodologies applied to the issue of adulteration. Equipment manufacturers usually do this. USP has a pharmacopeial education program that may help in this regard.
