Quality Control More Important Than Ever

Quality Control More Important Than Ever

Ensuring quality control has become increasingly important in light of recent government activity surrounding dietary ingredients such as kava and ephedra. Federal regulators are seeking to ensure substantiated label claims, while supplement manufacturers are formulating products to win over a more skeptical consumer base.

In order to maintain the industry's integrity, quality ingredients have become the cornerstones for the so-called "responsible" supplement companies. To follow are opinions from industry executives on what constitutes a quality ingredient, as well as debates on certifications, standardization, trademarks, patents and intellectual property.

What defines a quality dietary ingredient or formula?

Gary Bennett, marketing manager, National Enzyme Co.: It starts with sourcing the highest quality ingredients available. Those ingredients are double-checked with customer specifications. The ingredients are then blended to a uniform consistency for bulk powder sale or creating encapsulated product. At specific points in the manufacturing process, samples should be taken for analysis for microbiological contamination. In addition, we provide quality control inspection of all encapsulated and bulk powder products.

Hollie Martin, business development scientist, Hauser Laboratories Division of Microbac: A quality ingredient has a known, tested amount of active ingredients, is contaminant free, and is extracted through a process that does not alter the active ingredient.

Max Motyka, Ph.D., director of Human Products Division, Albion Advanced Nutrition: A quality ingredient is one that is consistent, meeting its product specifications with a high degree of regularity. In addition, a quality dietary ingredient needs to produce the benefits that it claims to produce.

Todd Norton, president/chief operating officer, Sabinsa Corp.: A good question; unfortunately, the answer depends on who you talk to. While there are a number of manufacturing companies that have set certain in-house standards, there are few agreed-upon industry standards that set a baseline. Therein lies one of the fundamental challenges facing the dietary supplement industry in defining quality in a dietary ingredient. First and foremost, an ingredient should be safe at the recommended dosage. This can often be assessed by historical or empirical use, or by a recognized method of evaluation to determine possible toxicity. Studies on efficacy and analysis on amounts of residual solvents, pesticide residues, microbial counts and/or other contaminants should also be factored in. But again, without some sort of consensus from industry on what such limits and criteria should be, the playing field is not level. It is a moving target.

David Parish, president/chief executive officer, Designed Nutritional Products: Safety, efficacy, purity and consistent potency are all components of a quality ingredient. Technical support in the form of validated analytical test methods and information on product storage, dosage and application are also important. The goal of delivering a quality dietary ingredient should include establishment of a legitimate expectation with the customer followed by performance that consistently meets or exceeds expectations.

Kathleen Pompliano, M.S., R.D., manager of new business development, NSF International: A quality ingredient would have to meet specifications for potency and stability over the course of its shelf life, and it should have solid efficacy and safety studies behind it. NSF certification is an option available to manufacturers and suppliers to demonstrate a product meets label claims, is in compliance with DSHEA and other pertinent federal regulations, and is manufactured in a facility that follows good manufacturing practices.

Jerry Rayman, vice president of sales and marketing, PAL Laboratories: Generally speaking, we vendor qualify our suppliers so that we know the type of companies we purchase from. When we receive the goods, we check that they are exactly as we ordered them, and we lab test them to ensure, for example, there are no microbes growing in them.

Rodger Rohde Jr., president, Triarco Industries: Meeting the desired specifications consistently helps to ensure that we achieve the desired outcome--consistently. "Intermittent quality" is an oxymoron.

How do the various certifications (i.e., GMP, kosher, organic, ISO, etc.) support the quality of a product--Do more certifications mean higher quality?

Bennett: Our company holds two certifications: GMP certification through NSF International and VPP/Star site status through OSHA. According to NSF, its GMP certification "builds credibility for manufacturers and ingredient suppliers by verifying conformance to NSF Draft American National Standard 173-Dietary Supplements." Despite the fact that DSHEA charged the FDA with establishing GMPs for the dietary supplement industry, FDA only now issued GMPs for our industry. In the absence of regulatory guidance, the NSF draft provided the only reasonable standard for GMPs within the industry. These GMPs are designed to ensure that the products produced at certified facilities are sanitary and of reliable quality. While our VPP/Star status can only claim to ensure the safety of our employees, the sanitation provisions designed to protect our employees indirectly help to ensure our products are also sanitary.

Martin: More certifications do not necessarily mean higher quality. It depends on the requirements for the certification. Some certifications require a great deal of checks and balances to ensure the results are as accurate as possible, while other certification programs require only a few things be done. Each certification program needs to be evaluated on an individual basis.

Motyka: Attaining more certificates does not automatically denote higher quality. Using a single certifying agency with high standards is much more credible than lots of certificates from agencies of low standards. Acknowledgement of the certifying agency, what they measure and what their standards are tell you more about the value for that standard toward guaranteeing quality.

Norton: Certification doesn't automatically guarantee quality, and in and of itself is not an end point. It simply provides a framework for carrying out procedures and practices that are designed to ensure greater product consistency over time. However, certification is recognized as an integral part of defining quality. But the success of any certification program is inherently tied to its inputs. If a substandard ingredient(s) is input into a certified system, a substandard product(s)--certifiably manufactured--will be the result. It comes down to how the system is managed once certified.

Parish: Quality certifications generally do mean higher quality, but this is not always the case. They are, however, an indication of a certain mindset (i.e., record keeping, attention to detail, problem solving and continual improvement). All activities within any business naturally gravitate to the path of least resistance. If not controlled, this path seldom leads to the desired outcome. Quality certifications help ensure that the channels of least resistance within a business also lead to the desired outcome.

I think most people can see that it isn't a certification of a product so much as a certification of the way activities are conducted within a business on a day-to-day basis. In my experience, quality certifications always give a good return on investment, but the return is still directly related to what a company puts in. The more seriously a company embraces quality certifications, the more profoundly the quality of its product will be affected in a positive fashion.

Pompliano: Certifications are a way for manufacturers and suppliers to have third-party verification that their products meet defined standards which may include quality and other parameters. Organic certification demonstrates compliance with the NOP [National Organic Program]. Organic certification does not ensure the ingredients or the finished product have been tested. The level of quality depends on the type of certification, but for supplements, the NSF product certification denotes the production facility is in compliance with [NSF] cGMPs, as well as that the product has been tested, has accurate label claims and does not contain contaminants or adulterants. A GMP certification or registration demonstrates the production facility is in compliance, although it does not always ensure the supplement quality.

Rayman: Certainly, certification is an indication of the quality of the company you're dealing with. Because they have a certification, that doesn't exclude them from being checked and verified, but it gives you a higher comfort level.

Rohde: Independent certifications (when legitimate) show a mind-set and commitment from management. The key, once again, is following those guidelines on a daily basis to help ensure a consistent outcome.

How does standardization come into play in the realm of quality control?

Martin: Standardization of raw ingredients, if done properly, will help ensure the product contains what the label indicates. Standardization of test methods allows testing results between laboratories and manufacturers to be more comparable. Standardization of dosage and active ingredient content provides consumers with necessary information for an informed choice.

Motyka: Standardization is critical to quality control. It is virtually impossible to measure quality without standards. Standards give quality control the very measuring stick needed by which to judge anything. Without standardization, there is no measure of quality.

Norton: There are a number of factors that can impact the chemical composition of a botanical, such as the region in which the botanical is grown, time of season when it is harvested, maturity of the plant part being used, watering conditions, etc. To some extent, standardization can overcome the realities of dealing with what Mother Nature offers to provide a more consistent ingredient from batch to batch. Some ingredients are standardized to marker compounds if a specific chemical is not known or identified as the active; but in many instances, specific chemicals are identifiable and known to be responsible for a given physiological benefit. If done right, the process of standardizing botanicals will provide consumers with a greater opportunity to experience consistency in the supplements they take. If consistency equates to quality, then everybody benefits.

Parish: There is a big issue of consistent potency when dealing with natural products. Because there are so many variables that can affect the level of actives, controlling them all is either impossible or monetarily unfeasible. As far as I'm concerned, if we are to have tight specifications and consistently meet them, standardization of some sort for key actives is an absolute necessity.

Standardization of testing methods is also a necessity as the results of analytical testing are frequently as diversified as the facilities performing the tests. I believe that within reason, we should have validated testing methods that are neither people- nor place-dependant. Some positive steps are being made in this direction, but we have a way to go yet.

Rayman: We have fewer issues with standardization when you continue to buy the same product from the same raw material suppliers. If we buy a standardized extract from a company, we know we'll get the same ingredient every time--and that's where our concern lies.

Rohde: Standardization has been made possible through advances in both the analytical and botanical fields of science. Scientific research has revealed the active ingredients or marker compounds that are responsible for the health benefits of many herbal products. The ongoing research in these fields will lead to a greater role for standardization in our industry and, in turn, a greater role for quality control. In our company, for instance, we continually upgrade our analytical testing and manufacturing capabilities in order to deliver standardized products.

Christopher L. Steele, M.S., principal, NSF International: You can't achieve quality without standardization--the issue becomes a moving target. If quality is used as a benchmark between products, as it is, standardization is a bridge between the products relative to quality.

There has been a decent amount of activity lately surrounding patents and trademarks--how do these things affect quality control?

Nena Dockery, technical services and regulatory manager, National Enzyme Co.: One of the main purposes of patents and trademarks is to protect the interests of a company that has devoted time and expense into researching ideas and concepts. Ideally, ingredients and products protected by patents have been extensively studied and represent an increased degree of quality in both safety and efficacy. At NEC, for the concepts we wish to patent (or trademark), we commit additional time and resources in developing a blend of ingredients in optimal proportions to produce a safe and extremely effective product.

Motyka: Patents and trademarks, in and of themselves, do not necessarily translate into quality. Patents guarantee some measure of uniqueness and imply a measure of effectiveness in certain cases. A trademark is a company seal of sorts and is only worth what the company behind the trademark represents. However, once a company develops a solid reputation for quality, etc., the trademark can take on great positive meaning.

Norton: Typically, when a dietary ingredient is trademarked or is granted patent status, something specific to that particular supplier's material is deemed unique to that ingredient. This position of uniqueness is most often directly tied to results of research efforts that have been performed on a given material. If the research efforts have been conducted under reasonably well-controlled conditions, and the results are encouraging, if not outright favorable, the logical thought is that this ingredient really works--it is a quality compound. To differentiate it from other like materials, a trademarked or patented ingredient can offer the supplier/owner an advantageous position in an industry. Such points of differentiation give a manufacturer or marketing company strong reason to tie in with a given supplier over the long term because of the mutual benefits to be derived from working together.

Parish: Trademarks, composition of matter and/or use patents are good ways to distinguish products and protect market share. However, once a name is associated with a given brand, compound or application, strict quality control is vital to maintaining the integrity of product and corporate image. Entire markets have been destroyed through careless quality control in the past. It is also important to protect a market share from infringers with lower standards of quality control that could serve to topple a legitimate market.

Rayman: We try, in all cases, to buy patented or trademarked ingredients for our customers. We feel those are the companies that have invested the time and money to research the products and have substantiation behind the claims they're making for their products.

Rohde: Patents are generally not cheap. We should know, we have 10 and several more pending. If a company is willing to commit significant resource to a patent, it stands to reason that the commitment should run through the entire product--especially quality. Trademarks are somewhat different. They act as more of a signature of the company they represent. The real question is--Is the company signature worth anything?

Steele: I struggle to make the assertion that a patent or trademark denotes quality. To achieve a patent suggests a unique process or procedure--it doesn't make a reference as to whether the ingredient has been benchmarked to standards or evaluated for quality.

How does the issue of borrowed science or infringement of intellectual property undermine the impression of quality supplements?

Martin: Proprietary methods are currently the standard for natural products testing. Unfortunately, the methods are of little value if the testing results between laboratories and manufacturers are not comparable. Incompatible test results remove the quality comparison component within the industry. The use of standardized test methods would help eliminate this problem; but, until laboratories receive recognition for their test method contributions, they have little incentive to disclose them.

Motyka: Borrowed science can be very detrimental to this whole quality issue. A quality supplement or ingredient is supposed to deliver the benefits that the producer attaches to that ingredient or supplement. Borrowing the science of another to support claims in a less than honest way can lead to products that do not provide the consumer with the benefits for which the product was bought.

Norton: First of all, developing, securing and defending intellectual property, usually based on some scientific undertaking, at least for this industry, does not come cheap. It may be described as a well thought out gambling investment. It is a gamble because, in most instances, you don't know what the absolute outcome will be. If you did, there would be no reason to do it. It is also an investment, because if the outcome of your efforts is positive and you can become the legal owner of this outcome, you can place yourself--and your customers--in a stronger position to benefit.

The industry is becoming more aware of the dangers and costs of borrowing science and infringing intellectual property. But tackling this issue is like running a marathon. It is an evolution. There are many purchasing personnel at manufacturing companies who see everything they buy as a commodity. They say to me you can't patent a natural product. To which I reply, not if one brand has been evaluated in multiple clinical studies in the United States and/or abroad; not if the U.S. patent office has granted patents recognizing that brand as unique based on the intellectual property developed to support its claims; not if other international governing bodies have also granted patent status in their own territories for that brand; and, not if the potency of the natural product can clearly be demonstrated to be used for one purpose only--that claimed and granted in the various patents.

The dietary supplement industry fought very hard a decade ago for the right to make claims on its products. The purpose was to better inform the consumer. No question there has been a measure of gross abuse; but, among other things, the law was intended to make possible the distribution of data and information that could be supported with tangible documentation for a given product's use. If this could be demonstrated sufficiently and effectively, a broader level of consumer confidence in the quality and efficacy of dietary supplements would be available for manufacturers to tap into and prosper from. What we sadly found, however, is that too many products ended up in consumers' hands that, despite the claims made, did not perform as the data and information suggested. Who's to blame? Is the industry collectively paying the price of borrowing science and applying it too liberally? You bet we are. Dietary supplement manufacturers continue to look, and ask, for ingredients that have substantiation behind them. Suppliers--some at least--are listening and are capable of delivering. But science, intellectual property and quality cannot be delivered at commodity prices. Manufacturers, pick your suppliers carefully. It is the key to your success.

Parish: It's likely that companies willing to forgo development of their own science on their products are also willing to neglect certain aspects of quality control. This, in turn, can damage the reputation of good science and superior quality.

Rayman: In every business, there are unscrupulous people. Those people who choose to use someone else's intellectual property and pawn it off as their own cast a negative light on the industry. If there were a way to stop it, we would be all for it.

Rohde: The sharing of knowledge in the scientific field leads to greater creative research. The infringement of intellectual property in our industry, however, has lead to the proliferation of competition accompanied by low-cost material suppliers with little or no quality control.

Steele: Does the issue of infringement of intellectual property have potential to undermine quality? I don't see that it does. It goes back to what underlies intellectual property. Did rigorous study and science go into developing the ingredient or compound? And that goes back to what constitutes a quality ingredient. If a person or company develops a product using those elements, you then have to measure whether there was a reduction in quality based on what was borrowed. If you "borrow," you've not introduced a deficiency, but if you borrow only part, there is potential for reduced quality.

What should manufacturers be looking for in creating a "quality" supplement?

Martin: A quality supplement starts with raw materials that are tested for their active ingredient content. It is produced through a manufacturing process that does not harm the active ingredients yet standardizes them in a form that allows the active ingredients to be readily absorbed into the body. The ingredients need to be traced and controlled throughout the manufacturing process. Finally, the final product needs to be tested for label verification.

Motyka: Manufacturers need to make sure that the ingredients they use are quality ingredients and are included at levels that are of real nutritional benefit. They need to be sure the ingredients used are supported by their own science, not just puffed up claims based on the work of others. A quality supplement must be made to assure maximum bioavailability for the ingredients that they incorporate.

 Norton: I would hope that the reputation and track record of the ingredient supplier they plan to buy from would be important to them. There is growing demand from manufacturers who are asking for, or looking to suppliers to provide, more documentation and justification on why their particular ingredients may be worth further consideration. The costs involved to provide such support has to somehow be reflected in the price of the ingredient. Some manufacturers recognize and understand this investment/benefit relationship, others do not or simply don't care. In many instances, the price of the ingredient is what most influences the purchasing decision. In speaking with other suppliers who have made the consistent commitment to provide this type of support for their ingredients, one of the biggest hurdles they face is being able to sell their goods at a price sufficient to recoup their costs and have something left over to apply the same approach to other ingredients. If manufacturers continue asking for this support, it cannot be looked at as a commodity. Costs do add up quickly, in some instances to the tune of several dollars a kilo more. It is not always universal, but in most instances, you really do get what you pay for. One other practice that must be given more attention in creating a quality supplement is using the recommended dosages for primary, key ingredients. There are too many formulations being offered that contain insignificant amounts of key ingredients, quality or not, to yield the purported claims and benefits for the product. In my opinion, there is no greater disservice a manufacturer can do to a consumer. If this type of formulation approach is going to be used, then investment by the manufacturer in a clinical trial for the given composition should be undertaken to see if the benefits are as hoped for.

Parish: I don't believe any business in the industry wants to hurt somebody, especially since we are already under such scrutiny. Safety should be first and foremost, though fully establishing this is somewhat difficult to define. Second: We all sell products, but what people pay for is a benefit. A quality supplement must do something good. This "something" should be predictable, measurable and consistent from one batch to the next.

Jo Ann Peterson, director of quality assurance, National Enzyme Co.: I would break this into two main areas. The first being external factors, such as the importance of sourcing proven quality materials (and) packaging components. The second being internal factors. Manufacturers should always be willing to step back and critically evaluate their own facilities. Processes and procedures must be clearly defined, understood, and most importantly followed by everyone involved in the manufacturing process. One thing that I use for self evaluation is the question of whether, at any time, we would welcome and be prepared for an inspection or audit, be it from FDA, OSHA or from one of our customers. If the answer is "no," we are not doing our job as a manufacturer of quality supplements.

Pompliano: Manufacturers should make sure their raw materials are quality raw materials. As a manufacturer, it is important to review all available safety and efficacy data. In addition, GMPs should always be followed, and labeling information should be accurate.

 Rayman: Buying quality ingredients from reputable raw material suppliers--those people that are direct sourcing raw materials as opposed to brokers and in between people.

Rohde: Finished goods manufacturers should look for ingredients (quality ingredients as previously defined) that are aligned with the objective of the finished product. Those objectives can be a desired effect, price, or even physical characteristics. However, if you start with substandard ingredients the result is substandard product. If one takes junk ingredients and puts them through a GMP facility using million dollar pieces of equipment run by highly-trained, well-paid technicians and carefully places the finished goods into expensive packaging--it's still junk.

What is your speculation on the effects the federal GMPs will have on the industry as a whole, and do you think they will affect your operations specifically?

Jerry Holvick, manufacturing manager, National Enzyme Co.: The industry as a whole I think will be affected drastically. I feel there are a lot of companies that are ready but even more that are not. NEC is ready and has been for several years. Manufacturing and QC have had all SOPs drafted and been in the mist of annual reviews to ensure correctness. Our documentation in every aspect of our operation has been ranked very favorably with many companies that have audited us. Since we are a contract manufacturer, some of our customers may be affected. The ways that our customers could be affected is if we only did the blend, capsules or bottled with no labels. We don't know a lot of times if these customers are following guidelines for cleanliness, label requirements or have proper documentation for the processing steps that they are completing. We have offered our services to all our customer to help prepare them for the future GMPs. NEC is continually looking for ways to improve and validate our efforts and this last year we were given the NSF GMP certification.

Martin: GMPs will increase the cost of manufacturing and testing throughout the industry. This in effect may cause smaller companies to be forced out who do not have the funds it will take to bring their companies up to GMP standards. We don't believe our operations will suffer significantly from the federal regulations due to the quality framework already in place. Also, tighter regulations might mean more third-party testing requirements for manufacturers and raw material producers, benefiting testing labs such as ourselves.

Motyka: GMP is going to be an everyday necessity. Even if finalized GMPs are some time away, the industry is demanding that manufacturers, etc., adhere to GMPs. Done the right way, GMPs can assist in making sure the consumer ends up with quality products. Albion is constantly working to improve its quality and to make our GMPs a continuously improving process. Companies that resist living by GMPs are playing a risky business and will be in danger of being put out of the marketplace.

Parish: The message is clear. Get with it, or get out! The entire industry will be affected by federal GMPs to some degree, though there is some doubt in my mind as to whether our industry will ever be acceptable to the FDA regardless of compliance. However, we all have room for improvement so as long as the line drawn is reasonable; we all need to step up. At this point, I consider GMPs optional. No one is going to force you to stay in business.

Pompliano: The federal GMPs will give companies a benchmark for manufacturing practices. A lot of companies have, up to now, been hesitant to revise their manufacturing practices because they were waiting for FDA to come out with manufacturing practices specific to the industry rather than using food GMPs. I imagine there will be quite a few comments on the proposed GMPs from industry members. We'll have some opposition if some think the bar is raised too high. But it's good to see progress. There has been inertia without FDA's proposed GMPs.

Rayman: From PAL Laboratories' standpoint, we're looking forward to more scrutiny. We think that's the way the industry should go to ensure quality being put out to the consumer. We're compliant right now, so we're very much in favor of it. In terms of the industry as a whole, I think it will eliminate a lot of the smaller contract manufacturers in particular because they will not be able to spend the money to come up to those standards and, as a result, we'll have better product out there.

Rohde: Triarco Industries will have no problem embracing such a program. For years, we have maintained a quality system (ISO 9000) and GMP program that is more stringent than the proposed nutritional supplement GMPs. As for other companies? Maybe there will just be fewer of them.

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