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Industry Roundtable: Ensuring Compliance & Improving Quality

Albion Minerals®
Compliance & Quality Compliance & Quality

The Participants Are:

• Mariko Hill, Product Development Executive, Hong Kong, www.gencorpacific.com

• Dan Lifton, President, Maypro Ventures, Purchase, NY, www.maypro.com

• Roberto Pace, Vice Corporate Quality Director, Indena, Milan, Italy, www.indena.com

• Andrew Shao, PhD, Interim, Senior Vice President, Scientific & Regulatory Affairs, CRN, Washington, D.C., www.crnusa.org

• Gary Swanson, Senior Vice President, Quality Assurance and Control, Herbalife Nutrition, Torrance, CA, www.herbalife.com

• Ed Wyszumiala, Director of Customer Engagement, Dietary Supplements, U.S. Pharmacopeia (USP), Rockville, MD, www.usp.org

Nutrition Industry Executive’s (NIE) panel of industry experts tackles a range of issues that the industry is dealing with, including economic adulteration, traceability, cGMP (current good manufacturing practice) compliance, good agriculture collection practices, and even mediocrity. Initiatives, such as the The Supplement OWL (Online Wellness Library) and the NHP Research Alliance are discussed. Plus, our experts weigh in on the pros and cons of genetic ID testing of plant materials.

NIE: What is the biggest quality obstacle right now for the natural products industry: Economic adulteration, or something else, and why?

Lifton: Mediocrity is one of the biggest obstacles. Just formulating with the minimum, or “fairy dust,” levels of ingredients just to be able to list them. Just sourcing with low-quality ingredients. Just manufacturing to the minimum acceptable standards. Not worrying about whether the products and ingredients have human clinical data behind them. Just skirting by with marginally acceptable claims and compliance. These are the most widespread problems, and the hardest to change for many companies, unfortunately.

Shao: The mainstream, responsible natural products industry develops, manufactures and markets, safe, high-quality products for consumers. However, as with any regulated industry, there are outliers looking to game the system for economic gain, at the expense of consumer trust and well-being. Even for well-meaning companies, quality challenges remain.

Consumer demand for natural products is at an all-time high and the industry is scrambling to meet that demand at even lower cost and with better convenience. Economically motivated adulteration (EMA) is not itself a root cause of quality challenges for the natural products industry—it is an unfortunate consequence resulting from a confluence between market forces (demand), lack of transparency in business practices, commoditization of the sector (price pressure) and lack of accountability (enforcement).

One might add lack of minimum quality standards to that mix, however, for example some of the most commonly adulterated botanical products are not lacking standards (analytical methods, reference materials, limits on contaminants, etc…), and EMA often occurs in spite of well-established standards.

These factors can conspire to create a culture where key questions are not asked, price is the number one priority and unscrupulous adulterators can hide their practices. Such a culture can be a powerful supporter of EMA.

Pace: I agree. Economic motivated adulteration is one of the main issues today. In the last few years, adulteration has become very sophisticated and difficult to be discovered with conventional analytical methods. And so the main problem is product safety.

Wyszumiala: The largest quality obstacles facing most companies right now are related setting proper specifications and utilizing properly qualified reference standards for determining the correct identity of incoming dietary supplements ingredients.

In many cases, manufacturers are setting specifications in a manner that does not fully verify the quality for the incoming dietary supplements ingredients and are not utilizing the proper test methods to fully verify that the incoming materials meet appropriate specifications. In too many cases, only infrared spectrometry (IR) is still being used, and while IR methods can be useful, they are not necessarily the best methods for all ingredients.

The problem with not utilizing a proper reference standard for identity is an ongoing issue. If the identity of an ingredient is not properly qualified to a reference standard, then there is no way to fully verify its identity. Testing against a supplier’s sample is not enough to verify the ingredient’s identity. If the identity of the ingredient cannot be confirmed, it can lead to a misbranded, adulterated, mislabeled product and GMP compliance cannot be achieved.

Swanson: Many manufacturers and raw material suppliers use the moniker of quality when describing or marketing their products and ingredients, but what does that really mean? How many are committed and invested in following good manufacturing practices?

Many manufacturers either don’t have the resources to invest in developing quality control systems, including the verification of quality of their ingredients. Some fly under the radar and don’t know how to comply with the Food Safety Modernization Act and the other regulations. Others operate in isolation and seldom receive independent technical evaluation to measure their compliance and performance, which jeopardize the implementation of quality standards in operations and the supply chain.

As an industry, we are obligated to set the highest standards and we have to do a better job of regulating our own industry.

As a member of the food and nutraceutical industry, there is a need to collaborate to develop the appropriate methods to mitigate the risk of adulteration. Analytical methods need to be specific in order to ensure that the correct species and parts are identified.

NIE: What is the biggest compliance (regulatory or legal) issue in the natural products industry right now?

Shao: The greatest regulatory compliance challenge for the natural products industry continues to be with the cGMPs. Certain categories of products (such as botanicals) are complex and can be challenging to manufacture consistently due to natural variation and availability of raw material supply. For some, a lack of minimum quality standards complicates things further. However, overall responsible industry has made great strides in cGMP compliance since the regulation was finalized more than 10 years ago.

On the legal front, the greatest issue continues to be products tainted with illegal drugs—a form of EMA. This action by a few outliers undermines the confidence of many stakeholders (not just consumers) in the industry. This remains an area of priority for CRN and its members.

Wyszumiala: I agree. The biggest regulatory compliance issue facing the industry at this point is still the lack of full compliance with GMP regulations. While the progress in GMP compliance over the last decade has been very positive, there are still significant gaps that need to be addressed.

Testing of dietary supplement products to show that they properly meet label claims is an ongoing concern. In many cases, companies are testing only a small portion of the product for verification against the product specification. This allows for products that potentially don’t meet label claims to be released.

Swanson: The natural products industry needs better guidelines in defining the identity, potency and purity of botanical ingredients. The botanicals need to be verified to be the right species, concentration and without non-declared addition or substitution.

Hill: Currently, CBD is gaining enormous traction in the natural products industry for its “anti-inflammatory” and anxiolytic properties; however this hemp-only derived substance is not approved as a dietary supplement by the U.S. FDA (Food and Drug Administration). Even without solid clinical evidence for its efficacy on non-diseased human population, there are still numerous products out in the market using this ingredient without claims.

The industry therefore needs to prepare alternatives for when regulatory boards start clamping down on these issues. Levagen+ by Gencor provides a great alternative to CBD, having similar mechanism of actions to CBD by having influence on the endocannabinoid pathway. Levagen+ is fully traceable, approved by the U.S. FDA and has GRAS (generally recognized as safe) status.

NIE: The Food Safety Preventive Controls Alliance (FSPCA) developed a Preventive Controls Qualified Individual (PCQI) course that is recognized by the FDA. Will getting staff qualified under this be one important step?

Wyszumiala: Yes, very much so. Designating the proper staff, and having them go through PCQI training, will help ensure that quality teams have the correct training and understanding of current Food Safety and Modernization Act (FSMA) requirements. This model also makes a company designate the individual(s) responsible for their food and dietary supplements safety plans, implementation and continued compliance.

Shao: FSMA is a massive and complex law. Reviewing FDA’s website, there are nearly 20 documents on proposed or final regulations and nearly 60 documents on draft or final guidances. That’s a tremendous amount of information to digest and implement. These types of offerings could play a pivotal role in educating regulators and manufacturers and placing them in better positions to enforce and comply with all the requirements.

Swanson: Professional certification, such as that created by the FSPCA is really a testament to how important the work is that we do to in our field to ensure safe manufacturing practices in order to protect consumers. The nationwide certification is something we would encourage our staff who are not yet certified to look into the course. Separately we continue to make investments in the latest analytical technologies, laboratory instrumentation and scientific training to improve analytical efficiency and accuracy on the production line.

NIE: Briefly, where are we on genetic ID testing and verification of plant materials and ingredients?

Shao: Despite the hype created by the NY Attorney General a few years back, DNA-based assays for botanical ingredient identification are not a panacea. Analytical methods experts tend to agree that while such methods can be useful in identification of plants (including adulterating species), there are limitations, particularly with respect to highly processed or extracted plant material. Often these ingredients don’t contain any intact DNA and thus these methods would not be fit-for-purpose. The message from the experts is, “Don’t rely solely on DNA testing to identify ingredients that have been processed.” That said, great progress continues to be made towards refining and validating the methodology.

Wyszumiala: Since the New York Attorney General findings in 2015, the industry has been working in various ways to implement DNA ID testing as part of the qualification of botanical ingredients. DNA testing may help in the proper identification of certain botanical ingredients, but should not be the only tool used. Additional testing maybe needed to fully confirm the identity of a botanical ingredient, especially when qualifying and utilizing formulations that do not include the whole plant, such as botanical extracts.

Lifton: The technology behind this has grown by leaps and bounds in the last few years. As long as natural botanical variability is sufficiently well allowed for in the methods of analysis and identification, then it will make it better for manufacturers who are doing their due diligence and for suppliers to ensure that what botanical materials they are buying is what they are getting. Ultimately, consumers will be able to have greater confidence that what they see is what they get.

Pace: Important improvements have been made on genomic ID of plants. Recently, our company succeeded in [developing tests] with specific diagnostic kits for each specific species. This technology is under evaluation of USP and FDA and hopefully very soon we will have compendial methods.

Nevertheless, the genomic ID test is just one piece of the puzzle of the ID tests of botanicals: Botanical ID and chemical ID tests remain of paramount relevance for the correct identification of botanicals and the main weapons to fight adulteration.

NIE: On this topic, there is a lot more interest today in genetic ID verification for probiotics—why is this important?

Shao: Probiotics—like botanicals—pose unique technical and analytical challenges due to their complexity. Science indicates that safety and efficacy is strain-specific. The CRN-IPA Best Practices Guidelines for Probiotics recommends probiotic-containing products indicate the genus, species and strain on the label. Also, FDA expects to see strain-specific information provided in new dietary ingredient notifications involving probiotics. Virtually the only way to decipher live probiotic strains is via genetic testing. So in this case, this method is a critical component of assuring the quality and authenticity of this important category of natural products.

Wyszumiala: Probiotics have similar challenges in determining the identification of specific strains. Many of the larger suppliers are actively working on building their genetic ID testing for the ingredients they are selling in the marketplace. This helps them differentiate their source materials from counterfeit materials in the market.

As with any newer testing methodology, there is still work to be done in this area, but it is a positive step, and suppliers are working to implement it as part of their “toolkit” to help verify their materials where appropriate.

Lifton: I do see that this is especially important for probiotics, because, with the wrong strain, you can go from effective to worthless in an instant.

NIE: Also briefly, what are the top one to two advances in substantiating fruit-and-vegetable serving claims for whole-food powders?

Shao: The “advances” in this area are based on manufacturers’ commitment to providing the proper contextual information and qualifying language for claims. Care should be taken when considering fruit and vegetable equivalency claims such that they are truthful and not misleading. This can be accomplished for example, by highlighting a specific nutrient or collection of nutrients in the fruit powder (e.g., vitamin C and fiber) relative to a given serving of fruits and vegetables. However, simply stating that whole-food powders are equivalent to fresh fruits and vegetables would be misleading, as the powders have undergone significant processing that may remove a number of key nutrients, some of which science has not even identified.

Swanson: Supplier verification of ingredients and new technology development, such as NMR and Q-Bit genetic sequencing techniques, have moved the needle for natural products identification and quality.

NIE: What one advance in ingredient delivery or enhanced bioavailability are you most excited about?

Lifton: Well, you asked about probiotics before. And at Maypro we’re pretty excited about our ProDURA proprietary branded ingredient. ProDURA Bacillus coagulans is a unique strain of spore-forming bacteria. In their spore form, the bacteria are dormant and encased in an outer shell, allowing them to withstand the harshest environments. When they encounter the perfect conditions of temperature, pH, and moisture in the large intestine, they then revert to their active form. The result is a highly resilient and bioavailable probiotic that’s able to handle extreme conditions—like including high temperatures, processing, stomach acid, and bile—and is room temperature-stable for up to three years.

Pace: Phytosome is Indena’s completely natural biomimetic strategy to optimize the solubility and bioabsoption of selected botanical-origin ingredients, reducing their self-aggregation.

Hill: The development of LipiSperse delivery technology by Pharmako Biotechnologies has taken enhanced bioavailability and functionality to another level. With numerous pharmacokinetic studies displaying its ability to increase bioavailability of lipophilic substances, LipiSperse is currently the most innovative and effective delivery technology for lipid-based substances developed to date.

Gencor’s Levagen+ (palmitoylethanolamide) and Hydrocurc (curcumin) both use this technology, helping them have enhanced bioavailability, functionality (into various formats—i.e. powders, effervescents, RTD shots), as well as having high loading (90 percent), with only 10 perent excipient. This leads to better compliance of the product by end-users.

NIE: In 2018, did the industry do a better job, overall, with purity and using analytical labs to test for heavy metals, toxins and other contaminants. If yes, how so? If not, why?

Wyszumiala: Industry has been diligently working apply purity standards for dietary supplements ingredients and products. I have noticed companies are implementing more rigorous and routine testing for heavy metals, pesticides and residual solvents.

Swanson: I don’t entirely agree. The natural products industry still reacts to regulation changes in order to make changes in the quality of ingredients. We have not seen a dramatic improvement in quality or purity of natural products in the last three years, as we expected. The industry needs to step up and set standards for manufacturing and using botanical ingredients. The responsibility remains with the marketers to ensure that the standards for purity, contamination and composition are being properly managed. The responsibility is on their shoulders because of specific regulations or laws already in place.

Lifton: I do think the industry has gotten a bit better with this, and the technologies—both for purification and methods of analysis—have improved. But quality starts in the soil, in the water, or in the fermentation medium. If you start with the very best inputs, you are more likely to have the best outputs.

NIE: Are advances in automation systems and technology enhancing quality or compliance? If so, briefly how?

Shao: Most definitely, technological advances are helping to improve quality and compliance. For example, electronic batch records, now instituted in many supplement manufacturers, help to streamline documentation and reduce errors during the manufacturing process. Customer relationship management (CRM) software help companies to collect, manage and respond to consumer complaints and adverse event reports. Product development databases assist companies in managing their product development pipeline, source and approve raw ingredients and manage production by contract manufacturers. All these advancements have led to more efficient quality management systems, fewer mistakes and better compliance overall.

Swanson: Advances in automation systems enhance both quality and compliance for the manufacturing process by reducing potential data entry errors and corrections, minimizing reworks and deviations, and reducing quality assurance review times.

At Herbalife Nutrition, we are using technology to create our own automation system (Electronic Batch Record), in order to have a more reliable, consistent, accurate, repeatable and predictable manufacturing process.

NIE: Do you have any additional comments?

Lifton: Without compliance you cannot have the best quality, because regulatory compliance is linked to sets of minimum standards not optimal standards.

And quality is not accidental; it’s intentional. Something you should strive for, and ensure, well before ingredient or finished product ever hits your warehouse. And it should follow your products every step of the way, until it is in the consumer’s trusting hands and sits on their supplement shelf.

Because that’s what it’s all about, at the end of the day. Fulfilling a promise to every consumer that they have purchased a quality supplement, one that is safe, one that is shelf-stable, and one that is effective. NIE

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