The issue of compliance has affected many aspects of the natural products industry.
Nutrition Industry Executive (NIE) asked natural product industry experts to discuss this topic, and offer their thoughts on what the industry can do to ensure safe products that comply with government regulations and help gain the confidence of consumers.
The Participants Are:
• Daniel Fabricant, PhD, Executive Director & CEO of the Natural Products Association (NPA), Washington, DC, www.npainfo.org
• Michael McGuffin, President of the American Herbal Products Association (AHPA), Silver Spring, MD, www.ahpa.org
• Mimi Potocnjak, President of Herbally Yours, Inc., Gilbert, AZ, (480) 892-8220
• Richard Soltero, PhD, President of InstantGMP, Inc., Cary, NC, (919) 657-0714
• Elan M. Sudberg, CEO & Microscopist of Alkemist Labs, Costa Mesa, CA, (714) 754-4372
• Lisa Thomas, General Manager of Dietary Supplement Programs, NSF International, Ann Arbor, MI, www.nsf.org
NIE: How important is attaining certifications to upholding the reputation of the industry? Are attaining certifications a way to stand out in the market?
Potocnjak: All certifications prepare us for meeting and exceeding industry standards and federal regulations. They serve as constant reminder and encourage third-party comments and ideas to help advance our own practices.
Sudberg: In the lab category, being ISO 17025 accredited is the highest level of achievement. While it is recommended to have such accreditation, it is not mandatory. Still it is an indication that important hoops have been jumped through and verified by an independent accredited body. It is important, though, to understand the scope of the accreditation. Many don’t realize that most ISO 17025 accreditations are for a specific procedure or methodology and not the lab’s quality as a whole. This is why even with such a high level of achievement, an on-site internal audit must be performed.
Soltero: Certifications demonstrate to customers that the manufacturing organization takes quality seriously. Good certifying organizations, like NSF and GMPCertification.org, set high standards for facilities, procedures and documentation that ensure the quality of the final products. The certifications are viewed by customers as a stamp of approval that helps them trust the products they buy.
Customers typically are not aware of the FDA (U.S. Food and Drug Administration) regulations and look to the certifications as something that differentiates the products they consume. There is a clear trend in the dietary supplement industry to seek out certification. It is likely there will come a point in time when all customers will expect GMP (good manufacturing practice) certification for all their products.
Thomas: NSF International Dietary Supplement and NSF Certified for Sport certification has really emerged as the champion of self-regulation in the dietary supplement industry. There are a number of reasons for the wide adoption of these programs:
1. NSF International Dietary Supplement and Certified for Sport programs are based on an accredited consensus-based standard that was developed with balanced input from regulatory, industry and academic representatives (NSF/ANSI 173). This group continually updates the standard to incorporate the latest science, regulatory and consumer information pertaining to dietary supplement safety and quality.
2. NSF International is a truly independent organization and for more than 70 years, our mission has been to protect and improve public health, conducting more than 200,000 audits annually in food, water, health sciences and other industries.
3. This is why the NSF mark is widely recognized by consumers, regulators and retailers as a mark of quality and safety. When a consumer sees the NSF mark on a dietary supplement, it means that the product has been tested and certified to verify label contents and that the product contains no harmful levels of specific contaminants. The manufacturing facility is also audited twice annually to verify compliance with good manufacturing practices (GMPs), in accordance with the federal regulation for GMPs—the FDA’s 21CFR111. When a consumer sees the NSF Certified for Sport mark on a dietary supplement, it means that in addition to the testing and auditing described above, the product has also been screened for nearly 300 athletic banned substances. This is why the NSF Certified for Sport program is used by the NFL, MLB, PGA, LPGA, the Canadian Centre for Ethics in Sports (CCES) and the New York City Police Department.
Fabricant: I think the way you stand out in the market is transparency. If the certification is done right and it’s a transparent audit or inspection process, you have the ability as a firm to pass that information on to your customer. Opening yourself up to added transparency is really where the marketing differential comes in.
NIE: What are some of the actions your company takes to ensure compliance?
Potocnjak: Herbally Yours, an innovative forward-thinking responsible contract manufacturer, whose employees are trained in GMPs and federal guidances, takes an extra step to educate our customers and walk with them though the process of creating new products or revising existing ones. Sudberg: In order to provide high quality data, which is what my clients seek, we ensure that internal operations are in compliance with the appropriate guidelines and best practices. This means a robust internal QA (quality assurance) team, equipment maintenance programs and regular internal and external audits to cGMP and or ISO 17025 standards. We do this internally so that we can provide high quality data to our clients ultimately for their compliance requirements.
NIE: How does your company aim to not only meet, but also exceed industry standards?
Sudberg: Unfortunately there is not much regulation of labs in the Natural Products Industry. There are best practices, however nearly no mandatory oversight of the labs exists. This means that it’s up to the members of the industry to regularly audit their third-party labs and do their own challenge testing of the labs (send a sample of known quality to several labs and compare results). An onsite physical audit by someone who knows what to look for is always the best way to check.
Alkemist Labs exceeded industry standards by being first in the industry to offer only fully transparent HPTLC ID lab reports. We have always felt there is nothing proprietary about test methods and reveal them freely because it’s science and is supposed to be representing the quality of our clients products. If the lab results and methodology is hidden then what does that say about the product? We also were first on the scene with only botanical microscopy and HPTLC fit for purpose testing where we employ, not the “shiniest” piece of equipment or methodology, but rather techniques that have been time tested and globally approved and, most importantly, are fit for the job. We’ve all see all too clearly recently how disastrous using testing methods that are not fit for purpose is. Lastly, our company is small and still has a soul that its employees care about. For that reason there is a sense of pride in the work we do and our customer support is unparalleled. NIE: How do associations and organizations assist companies in the industry in ensuring their compliance?
McGuffin: AHPA helps members and others in the industry comply with federal and state laws and regulations by producing a host of resources from guidance documents and best practice policies to educational events that explain regulatory requirements and provide strategies to meet these requirements. AHPA also maintains working relationships with policymakers to ensure that consumer and industry interests are continually represented in emerging areas of concern and during the drafting of laws and regulations.
Soltero: InstantGMP develops electronic batch record software and SOPs that reinforce good manufacturing practices. The software manages workflows and quality checks that are necessary for manufacturing products that must comply with FDA regulations. Each of the software modules, such as specifications, inventory and batch records, ensure that users are following GMPs. This makes manufacturing products that are in compliance with GMPs easy.
Thomas: Retailers and consumers want to know that they can trust the safety and quality of supplements. NSF International has analytical testing and technical auditing experts that help the industry fulfill this need by providing essential product testing and certification, GMP auditing and registration, and training programs for dietary supplements companies.
NSF International also brought together experts from regulatory agencies, industry and academia to develop the only consensus-based and accredited American National Standard for dietary supplements (NSF/ANSI 173), which NSF has been testing and certifying products to for more than 12 years. The number of certified products has doubled just in the last year as consumers seek safer supplements and companies step up to meet this demand. We now have more than 750 products certified.
Fabricant: Information, education and certification. People look to associations for rapid communication when there are any new rules or interpretations of rules that affect their business, so I think that information is step one. Step two is the education. I think that this organization [NPA] educates both retail and supply members on the appropriate aspects of the laws and regulations that affect their business. And finally, is certification. It’s one thing to have the education and have the information—but having a certification program, there is a huge value in that.
We’ve had or GMP certification for a long time, and we’ve had our natural certification in the marketplace, making sure that the products that claim natural on the label certainly meet that. I think that there is a huge value in that in terms of assisting companies with assuring their compliance.
NIE: Are companies putting more emphasis on demonstrating the credibility of their ingredients and communicating this to the public? How so?
McGuffin: Verifying and demonstrating the quality of ingredients remains a top priority for herbal supplement companies especially with the inherent challenges of an expanding global supply chain. Many AHPA member companies that have spent years building a reputation for quality are benefiting from the recent scrutiny of the industry as consumers place more emphasis on high-quality herbal supplement products.
Potocnjak: As contract manufacturer, FDA registered and inspected, NSF cGMP certified, we understand that we are crucial part of the nutritional supplement supply chain, therefor we operate under the quality system driven by transparency. Our efforts are emphasized on the quality of the ingredients we purchase and the testing to confirm the quality of those ingredients. It is our responsibility as contract manufacturing to help create products that enhance people’s life and heighten the credibility of the entire industry.
Sudberg: The only thing Alkemist Labs sells are lab services, composite reference botanicals and most recently added, phytochemical reference standards from France’s Extrasynthese. The last two are to support other labs, spanning from universities to the dietary supplement industry, in their efforts to comply with cGMPs and other regulations. We sell no ingredients to the industry or consumers and are solely a testing lab.
What we are putting emphasis on is transparency in testing. We believe that manufacturers owe it to their customers to tell them where, how and why they test their products. The days of keeping your testing lab a secret need to end. We have also begun a campaign to demystify testing, and are working to educate the industry through a series of videos, articles and other content marketing vehicles that explain some of the really geeky aspects of what we do. We’re passionate about testing and love to share that dedication.
Soltero: I see many companies put more emphasis on making the public aware of their product’s quality and compliance. This effort preceded the recent attorney general’s public display. It seemed more in response to a public that is becoming more informed and who actively seeks out information on the ingredients and benefits of the products they consume. The more the customers learn, the more they ask and the more the companies publish information that satisfies the public’s need to know.
Thomas: Absolutely. Evidence of this can be seen in the fact that the number of dietary supplements certified by NSF International has doubled just in the last year alone as consumers seek safer supplements and companies step up to meet this demand. Companies earn this certification because they see it as an investment in quality control, risk management and—in the case of NSF Certified for Sport—the ability to sell to elite and professional athletes.
Fabricant: Whether they’ve got a federal regulatory agency in their facility or a third party auditor, they are constantly opening themselves up to strangers, and that word of mouth travels. That’s really the key thing: Is the science behind it? Is the manufacturing procedure behind it? Those things can be communicated; those things are measurable. There’s a metrology, so any time there is some sort of measurability, people are going to put that out there—which isn’t a bad thing.
NIE: What ways can the industry exhibit compliance and transparency to gain trust from consumers?
McGuffin: The continued, steady growth in herbal supplement sales indicates that most consumers trust these products and the industry. That said, there are still prevalent misconceptions about the industry. Correcting these misconceptions and providing accurate information to consumers and lawmakers about the current, comprehensive regulatory requirements that the industry must comply with would help bolster consumers’ confidence in this class of goods.
Potocnjak: Media is always looking for sensational news, and often our industry is portrayed in negative light, often with outdated research, disproven studies, etc. We are still carrying the century-old burden of state fair “snake-oil” salesmen. But modern industry can regain that trust of the consumer, by providing them evidence, in the form of stability studies, clinical studies, research, community outreach, and communication. Industry associations, like NPA or Vitamin Angels, are just few examples of what an incredible job our industry can do when we join forces and unite.
Sudberg: It’s time to take quality out of the closet and wear it on your sleeve. Consumers want to know that the products they are taking match what the label says. By employing a quality centric value proposition rather than just hot new ingredients or small study backed claims, the consumers may begin to trust the industry again. I envision a day when you can go to the store, grab a product off the shelf, run its lot number using an app on your phone to bring up a detailed C of A for each and every ingredient. It doesn’t matter if the user knows what a good chromatogram looks like or what a bad base line looks like. It’s about accessibility of data, and willingness to make it available, that will earn the trust of the consumer back. The good news is that per cGMPs, these tests should already be performed and data available. Now it’s time to pay a web developer to make it accessible on your websites. It’s not that difficult or expensive to have PDFs posted and accessible. This is something only the good guys will do; sharing your quality is an underutilized competitive advantage.
Soltero: The best way to exhibit compliance and trust is to establish open communication. Be transparent about your process and quality controls. Make yourself available for customer questions and be honest with your answers. There are many FDA requirements that the industry takes for granted because they want to be in compliance and produce high quality products.
Thomas: Product certification and third-party GMP auditing and training are by far the best ways to demonstrate the safety and quality of dietary supplements to consumers.
Fabricant: The more firms are willing to pull back the curtain and let consumers see inside of the facility—that doesn’t mean you have to give up trade secrets or anything, but the more you can display the sorts of attributes, and the more you can answer tough questions—front facing instead of waiting for things to be asked. Are you pushing that information out? I think that’s the difference with this marketplace right now because if you’re not pushing information out, someone else can control your stories. What information are you pushing out? Is it transparent? Is it the kind of information that informs consumers’ decisions? I think those are really the key factors.
NIE: What are your company’s goals going forward in regard to compliance?
Potocnjak: As contract manufacturer we realize that our work with compliance is always evolving as regulation are changing, and we welcome new challenges, and new certifications. Our laboratory is growing in educated personnel, new testing methods are being developed daily, as new, modern, laboratory equipment is constantly added. We constantly challenge ourselves by adding new certifications, which serve as test of our abilities and commitment to quality we provide.
Sudberg: Our immediate compliance goal is to achieve ISO accreditation from A2LA. Our application went in this recent March and we are excited for our next audit. We also intend to be sure and share what scope the accreditation is for, since some labs don’t and the accreditation may not be for something relevant to the testing you need.
NIE: What changes do you foresee with the Food Safety And Modernization Act (FSMA)?
McGuffin: The Food Safety Modernization Act (FSMA) is the most comprehensive change to the Food, Drug and Cosmetic Act (FDCA) since it was initially passed in 1938 and the rules implementing FSMA will be coming into effect in 2015 and 2016. The FDA will be more involved in all steps of a food product operation starting with the initial supplier of an ingredient, both foreign and domestic, to the finished product manufacturer. The rulemaking process has been an excellent opportunity for FDA to engage with industry to understand the complexity and nuances of a manufacturing operation. FSMA takes into account the uniqueness of smaller farming operations and farmers that service local farmers markets which operate significantly differently than large scale farms. AHPA will be working to educate the industry to ensure it understands the new FSMA requirements and is prepared to comply. AHPA is also working to ensure FSMA regulations are consistent with congressional intent, maximize flexibility for compliance, and minimize confusing language that could hamper compliance, especially for small businesses. To date, AHPA has submitted more than 400 pages of comments and recommended changes to the draft regulatory language issued by FDA to implement FSMA.
Potocnjak: One of the biggest changes to the industry will be introduction of new dietary ingredients (NDIs). We foresee that it can provide positive change, if we learn and encourage better communication and sharing of data, research and marketing, between ingredient manufacturer, us as contract manufacturer and final distributor, which can only ensure that consumer is better informed and educated. On the opposite side, our concern is that NDI application will be costly and lengthy process, preventing creative start-up companies from succeeding.
Sudberg: The Food Safety Modernization Act (FSMA) is the newest and biggest change to the Food, Drug and Cosmetic Act (FDCA) to date. It’s been around since 1938, however FSMA will change manufacturing requirements for ingredient suppliers and the like. Ultimately increased compliance to regulations is a good thing for the consumers, but it also creates a level playing fields, which is good for the long term sustainability of the industry.
Soltero: The FDA has a history of expanding the sphere of influence for GMPs. They started with GMPs pharmaceuticals 40 years ago, then expanded to medical devices and then to dietary supplements. It is likely that they will find more areas where making products using GMPs will be useful for protecting public health.
Thomas: The FSMA makes significant amendments to the FDCA. It requires FDA to implement a sweeping array of new regulations and enforcement policies intended to better ensure the safety of food products marketed in the U.S., including dietary supplements.
Dietary supplement companies must understand the key elements of FSMA that may impact their operations, and in particular, the requirements around imported dietary supplement ingredients and products. Foreign suppliers will be required to comply with U.S. regulations for dietary supplements and the responsibility will be on the importing company to verify and demonstrate this compliance.
Because of our global reach, NSF International has been very active in helping facilities outside the U.S. demonstrate compliance with U.S. GMPs for dietary supplements through the NSF International GMP Facility Registration program. More than 400 facilities have earned NSF International GMP Facility Registration, and of those, over 100 are outside the U.S., including facilities in Austria, Belgium, Bolivia, Canada, China, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, Netherlands, Norway, Russia, Spain, Switzerland and Taiwan.
Fabricant: I think it just adds that ingredient suppliers will have to submit to those preventive control rules, which I think many of them already do. But it is good for them to have a system they can point to and say, “Hey look, this is how we do business.” It gives you an even playing field to start from. I think that that’s really the most encouraging thing. NIE
