Quality Control More Important Than Ever

Ensuring quality control has become increasingly important inlight of recent government activity surrounding dietary ingredients such as kavaand ephedra. Federal regulators are seeking to ensure substantiated labelclaims, while supplement manufacturers are formulating products to win over amore skeptical consumer base.

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

What defines a quality dietary ingredient orformula?

Gary Bennett, marketing manager, National Enzyme Co.: Itstarts with sourcing the highest quality ingredients available. Thoseingredients are double-checked with customer specifications. The ingredients arethen blended to a uniform consistency for bulk powder sale or creatingencapsulated product. At specific points in the manufacturing process, samplesshould be taken for analysis for microbiological contamination. In addition, weprovide quality control inspection of all encapsulated and bulk powder products.

Hollie Martin, business development scientist, HauserLaboratories Division of Microbac: A quality ingredient has a known, testedamount of active ingredients, is contaminant free, and is extracted through aprocess 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. Inaddition, a quality dietary ingredient needs to produce the benefits that itclaims to produce.

Todd Norton, president/chief operating officer, SabinsaCorp.: A good question; unfortunately, the answer depends on who you talkto. While there are a number of manufacturing companies that have set certainin-house standards, there are few agreed-upon industry standards that set abaseline. Therein lies one of the fundamental challenges facing the dietarysupplement industry in defining quality in a dietary ingredient. First andforemost, an ingredient should be safe at the recommended dosage. This can oftenbe assessed by historical or empirical use, or by a recognized method ofevaluation to determine possible toxicity. Studies on efficacy and analysis onamounts of residual solvents, pesticide residues, microbial counts and/or othercontaminants should also be factored in. But again, without some sort ofconsensus from industry on what such limits and criteria should be, the playingfield is not level. It is a moving target.

David Parish, president/chief executive officer, DesignedNutritional Products: Safety, efficacy, purity and consistent potency areall components of a quality ingredient. Technical support in the form ofvalidated analytical test methods and information on product storage, dosage andapplication are also important. The goal of delivering a quality dietaryingredient should include establishment of a legitimate expectation with thecustomer followed by performance that consistently meets or exceedsexpectations.

Kathleen Pompliano, M.S., R.D., manager of new businessdevelopment, NSF International: A quality ingredient would have to meetspecifications for potency and stability over the course of its shelf life, andit should have solid efficacy and safety studies behind it. NSF certification isan option available to manufacturers and suppliers to demonstrate a productmeets label claims, is in compliance with DSHEA and other pertinent federalregulations, and is manufactured in a facility that follows good manufacturingpractices.

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

Rodger Rohde Jr., president, Triarco Industries: Meetingthe desired specifications consistently helps to ensure that we achieve thedesired 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 morecertifications mean higher quality?

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

Martin: More certifications do not necessarily meanhigher quality. It depends on the requirements for the certification. Somecertifications require a great deal of checks and balances to ensure the resultsare as accurate as possible, while other certification programs require only afew things be done. Each certification program needs to be evaluated on anindividual basis.

Motyka: Attaining more certificates does notautomatically denote higher quality. Using a single certifying agency with highstandards is much more credible than lots of certificates from agencies of lowstandards. Acknowledgement of the certifying agency, what they measure and whattheir standards are tell you more about the value for that standard towardguaranteeing quality.

Norton: Certification doesn't automatically guaranteequality, and in and of itself is not an end point. It simply provides aframework for carrying out procedures and practices that are designed to ensuregreater product consistency over time. However, certification is recognized asan integral part of defining quality. But the success of any certificationprogram is inherently tied to its inputs. If a substandard ingredient(s) isinput into a certified system, a substandard product(s)--certifiablymanufactured--will be the result. It comes down to how the system is managedonce certified.

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

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

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

Rayman: Certainly, certification is an indication of thequality 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 ahigher comfort level.

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

How does standardization come into play in therealm of quality control?

Martin: Standardization of raw ingredients, if doneproperly, will help ensure the product contains what the label indicates.Standardization of test methods allows testing results between laboratories andmanufacturers to be more comparable. Standardization of dosage and activeingredient content provides consumers with necessary information for an informedchoice.

Motyka: Standardization is critical to quality control.It is virtually impossible to measure quality without standards. Standards givequality 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 thechemical composition of a botanical, such as the region in which the botanicalis grown, time of season when it is harvested, maturity of the plant part beingused, watering conditions, etc. To some extent, standardization can overcome therealities of dealing with what Mother Nature offers to provide a more consistentingredient from batch to batch. Some ingredients are standardized to markercompounds if a specific chemical is not known or identified as the active; butin many instances, specific chemicals are identifiable and known to beresponsible for a given physiological benefit. If done right, the process ofstandardizing botanicals will provide consumers with a greater opportunity toexperience consistency in the supplements they take. If consistency equates toquality, then everybody benefits.

Parish: There is a big issue of consistent potency whendealing with natural products. Because there are so many variables that canaffect the level of actives, controlling them all is either impossible ormonetarily unfeasible. As far as I'm concerned, if we are to have tightspecifications and consistently meet them, standardization of some sort for keyactives is an absolute necessity.

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

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

Rohde: Standardization has been made possible throughadvances in both the analytical and botanical fields of science. Scientificresearch has revealed the active ingredients or marker compounds that areresponsible for the health benefits of many herbal products. The ongoingresearch in these fields will lead to a greater role for standardization in ourindustry and, in turn, a greater role for quality control. In our company, forinstance, we continually upgrade our analytical testing and manufacturingcapabilities 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 movingtarget. 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 activitylately surrounding patents and trademarks--how do these things affect qualitycontrol?

Nena Dockery, technical services and regulatory manager,National Enzyme Co.: One of the main purposes of patents and trademarks isto protect the interests of a company that has devoted time and expense intoresearching ideas and concepts. Ideally, ingredients and products protected bypatents have been extensively studied and represent an increased degree ofquality 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 ofingredients in optimal proportions to produce a safe and extremely effectiveproduct.

Motyka: Patents and trademarks, in and of themselves, donot necessarily translate into quality. Patents guarantee some measure ofuniqueness and imply a measure of effectiveness in certain cases. A trademark isa company seal of sorts and is only worth what the company behind the trademarkrepresents. 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 istrademarked or is granted patent status, something specific to that particularsupplier's material is deemed unique to that ingredient. This position ofuniqueness is most often directly tied to results of research efforts that havebeen performed on a given material. If the research efforts have been conductedunder reasonably well-controlled conditions, and the results are encouraging, ifnot outright favorable, the logical thought is that this ingredient reallyworks--it is a quality compound. To differentiate it from other like materials,a trademarked or patented ingredient can offer the supplier/owner anadvantageous position in an industry. Such points of differentiation give amanufacturer or marketing company strong reason to tie in with a given supplierover the long term because of the mutual benefits to be derived from workingtogether.

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

Rayman: We try, in all cases, to buy patented ortrademarked ingredients for our customers. We feel those are the companies thathave invested the time and money to research the products and havesubstantiation 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 commitsignificant resource to a patent, it stands to reason that the commitment shouldrun through the entire product--especially quality. Trademarks are somewhatdifferent. They act as more of a signature of the company they represent. Thereal question is--Is the company signature worth anything?

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

How does the issue of borrowed science orinfringement of intellectual property undermine the impression of qualitysupplements?

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

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

Norton: First of all, developing, securing and defendingintellectual property, usually based on some scientific undertaking, at leastfor this industry, does not come cheap. It may be described as a well thoughtout gambling investment. It is a gamble because, in most instances, you don'tknow what the absolute outcome will be. If you did, there would be no reason todo it. It is also an investment, because if the outcome of your efforts ispositive and you can become the legal owner of this outcome, you can placeyourself--and your customers--in a stronger position to benefit.

The industry is becoming more aware of the dangers and costs ofborrowing science and infringing intellectual property. But tackling this issueis like running a marathon. It is an evolution. There are many purchasingpersonnel 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 onebrand has been evaluated in multiple clinical studies in the United Statesand/or abroad; not if the U.S. patent office has granted patents recognizingthat brand as unique based on the intellectual property developed to support itsclaims; not if other international governing bodies have also granted patentstatus in their own territories for that brand; and, not if the potency of thenatural product can clearly be demonstrated to be used for one purposeonly--that claimed and granted in the various patents.

The dietary supplement industry fought very hard a decade agofor the right to make claims on its products. The purpose was to better informthe consumer. No question there has been a measure of gross abuse; but, amongother things, the law was intended to make possible the distribution of data andinformation that could be supported with tangible documentation for a givenproduct's use. If this could be demonstrated sufficiently and effectively, abroader level of consumer confidence in the quality and efficacy of dietarysupplements 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 informationsuggested. Who's to blame? Is the industry collectively paying the price ofborrowing science and applying it too liberally? You bet we are. Dietarysupplement manufacturers continue to look, and ask, for ingredients that havesubstantiation behind them. Suppliers--some at least--are listening and arecapable of delivering. But science, intellectual property and quality cannot bedelivered at commodity prices. Manufacturers, pick your suppliers carefully. Itis the key to your success.

Parish: It's likely that companies willing to forgodevelopment of their own science on their products are also willing to neglectcertain aspects of quality control. This, in turn, can damage the reputation ofgood 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 itoff as their own cast a negative light on the industry. If there were a way tostop it, we would be all for it.

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

Steele: Does the issue of infringement ofintellectual property have potential to undermine quality? I don't see that itdoes. It goes back to what underlies intellectual property. Did rigorous studyand science go into developing the ingredient or compound? And that goes back towhat constitutes a quality ingredient. If a person or company develops a productusing those elements, you then have to measure whether there was a reduction inquality based on what was borrowed. If you "borrow," you've notintroduced a deficiency, but if you borrow only part, there is potential forreduced quality.

What should manufacturers be looking for increating a "quality" supplement?

Martin: A quality supplement starts with raw materialsthat are tested for their active ingredient content. It is produced through amanufacturing process that does not harm the active ingredients yet standardizesthem in a form that allows the active ingredients to be readily absorbed intothe body. The ingredients need to be traced and controlled throughout themanufacturing process. Finally, the final product needs to be tested for labelverification.

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

 Norton: I would hope that the reputation and trackrecord of the ingredient supplier they plan to buy from would be important tothem. There is growing demand from manufacturers who are asking for, or lookingto suppliers to provide, more documentation and justification on why theirparticular ingredients may be worth further consideration. The costs involved toprovide such support has to somehow be reflected in the price of the ingredient.Some manufacturers recognize and understand this investment/benefitrelationship, others do not or simply don't care. In many instances, the priceof the ingredient is what most influences the purchasing decision. In speakingwith other suppliers who have made the consistent commitment to provide thistype of support for their ingredients, one of the biggest hurdles they face isbeing able to sell their goods at a price sufficient to recoup their costs andhave something left over to apply the same approach to other ingredients. Ifmanufacturers continue asking for this support, it cannot be looked at as acommodity. Costs do add up quickly, in some instances to the tune of severaldollars a kilo more. It is not always universal, but in most instances, youreally do get what you pay for. One other practice that must be given moreattention in creating a quality supplement is using the recommended dosages forprimary, key ingredients. There are too many formulations being offered thatcontain insignificant amounts of key ingredients, quality or not, to yield thepurported claims and benefits for the product. In my opinion, there is nogreater disservice a manufacturer can do to a consumer. If this type offormulation approach is going to be used, then investment by the manufacturer ina clinical trial for the given composition should be undertaken to see if thebenefits are as hoped for.

Parish: I don't believe any business in the industrywants to hurt somebody, especially since we are already under such scrutiny.Safety should be first and foremost, though fully establishing this is somewhatdifficult to define. Second: We all sell products, but what people pay for is abenefit. 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, NationalEnzyme Co.: I would break this into two main areas. The first being externalfactors, such as the importance of sourcing proven quality materials (and)packaging components. The second being internal factors. Manufacturers shouldalways be willing to step back and critically evaluate their own facilities.Processes and procedures must be clearly defined, understood, and mostimportantly followed by everyone involved in the manufacturing process. Onething that I use for self evaluation is the question of whether, at any time, wewould welcome and be prepared for an inspection or audit, be it from FDA, OSHAor from one of our customers. If the answer is "no," we are not doingour job as a manufacturer of quality supplements.

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

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

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

What is your speculation on the effects thefederal GMPs will have on the industry as a whole, and do you think they willaffect 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 alot of companies that are ready but even more that are not. NEC is ready and hasbeen for several years. Manufacturing and QC have had all SOPs drafted and beenin the mist of annual reviews to ensure correctness. Our documentation in everyaspect of our operation has been ranked very favorably with many companies thathave audited us. Since we are a contract manufacturer, some of our customers maybe affected. The ways that our customers could be affected is if we only did theblend, capsules or bottled with no labels. We don't know a lot of times if thesecustomers are following guidelines for cleanliness, label requirements or haveproper documentation for the processing steps that they are completing. We haveoffered our services to all our customer to help prepare them for the futureGMPs. NEC is continually looking for ways to improve and validate our effortsand this last year we were given the NSF GMP certification.

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

Motyka: GMP is going to be an everyday necessity. Even iffinalized 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 theconsumer ends up with quality products. Albion is constantly working to improveits quality and to make our GMPs a continuously improving process. Companiesthat resist living by GMPs are playing a risky business and will be in danger ofbeing 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, thoughthere is some doubt in my mind as to whether our industry will ever beacceptable to the FDA regardless of compliance. However, we all have room forimprovement 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 inbusiness.

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

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

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