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Empower Your Brand with Certifications

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American consumers are swayed and influenced by seals of approval and quality. In fact, for some, the lack of any such thing will result in that product being put back on the shelf in favor of one that does. Simple. We like to feel secure and safe with what we use and consume.

And the dietary supplement industry is no different nowadays. Certifications matter. Each instantly conveys to a consumer that the product is non-GMO (genetically modified organism), kosher, vegan, halal or gluten free. With millions of individuals requiring that what they put into their bodies is free of an allergen or conforms to religious dietary rules, going through the process of certification to capture those specific interests will go a long way to long-term success of your supplement product.

Dr. Cheryl Luther, general manager of the NSF International’s Dietary Supplement Program, stated that retailers and consumers want to know that they can trust the safety and quality of supplements. Most dietary supplement brand marketers seek to produce safe, quality products and are striving to restore and maintain brand integrity by demonstrating their commitment to producing safer products for their customers. Third-party certification showcases their commitment to this practice.

Yet, she warned, “NSF International’s research has shown that some supplements in the market can contain harmful ingredients and contaminants, including drugs, and compounds that are not always listed on the label. A pattern of methamphetamine compounds such as DMAA, DEPEA and DMBA are cropping up under the deceptive guise of botanical extracts. This gives consumers the false impression that the ingredient is derived from plants. NSF International’s third-party dietary supplements certification program was created to test products to confirm what is on the label is in the product, and the product doesn’t contain harmful levels of contaminants.”

Luther reported that the number of products certified by NSF International doubled in 2014 and continues to increase as consumers seek safer supplements, and companies step up to meet this demand. NSF International now has more than 750 ingredients and products certified. NSF also has successfully audited and registered more than 400 manufacturing facilities to the good manufacturing practices (GMPs) specified in 21 CFR Part 111.

Another mounting concern among consumers nationwide is the presence of GMOs in produce and in food products made with natural ingredients, including supplements. “The need for non-GMO labeling is real as indicated by growing consumer demand and consumer advocacy groups, said Kelly Mae Heroux of Iowa-based FoodChain ID. She added that research conducted by NMI and others show that interest in GMO labeling for food products is on the rise. Non-GMO Project Verified went from a $5 billion to $12 billion industry in the last decade. Further, kosher and halal certifications for dietary supplements assist millions of individuals with strict religious dietary concerns.

Muhammad M. Chaudry, PhD, president and CEO of The Islamic Food and Nutrition Council of America (IFANCA) explained, “For consumers, halal certification of finished products is a must to be able to select suitable products. For sellers, including manufacturers, marketers and foodservice providers, halal certification is a gateway to the halal consumer. For importing countries, halal may be part of the import requirements for any product entering the country. With more than 1.6 billion Muslims, many countries require halal certification for ingredients and finished products to be allowed into the country.”

He added that even with products that may seem unquestionably halal, certification of such dramatically reduces the number of questions customer service representatives must field, saving time and money. In order to produce halal-certified finished products, manufacturers need halal certified ingredients. With the low cost of halal certification, ingredient companies are seeking halal certification for their ingredients to be acceptable to brand marketers that seek to address this market.

Rabbi Fogelman of OK Kosher Certification explained that kosher certification is a protocol of dietary laws that date to the time of Moses. Several million buy kosher for religious reasons, and there are several million consumers of ‘kosher for health’ reasons, meaning if they are lactose intolerant, they seek out the kosher parve symbol, which means that there is no dairy in the product. “The K enclosed by a circle symbol conveys that we, as the certifying agency, are testifying that the product, from the source, is made from the kosher protocol. Now, people think that ‘kosher’ means that a rabbi blesses the product—this is the farthest from the truth.”

Expanding Vegan Certification

Although not stemming from thousands of years of religious protocol, vegan certification provides assurance for the growing number of individuals who have made a dedicated choice to use only products that have no animal sources or testing. When it comes to dietary supplements in capsules, many ingredients are naturally vegan, however, choices had been extremely limited until recently.

In 2013, New Jersey-based Capsugel announced that it had been awarded vegan certification for four plant-based capsules—Vcaps, Vcaps Plus, DRcaps, and Plantcaps—which are free of additives, preservatives, allergens, starch and gluten, plus are non-GMO, kosher and halal certified, and approved by the Vegetarian Society. “But we felt a vegan certification would further expand the appeal of our plant-based capsules into a very targeted niche in the booming life-style driven market,” explained Missy Lowery, senior marketing manager, Capsugel Americas.

According to Lowery, within the natural products consumership, vegetarians are central, with vegans as a critical subset acting as the trendsetters. In the U.S., 38 percent of supplement users say that a vegetarian or non-animal source is important when choosing a supplement in 2013, up from 35 percent in 2011 and 26 percent in 2006; this market segment is among the most frequent users of supplements. (Natural Marketing Institute Supplements/OTC/Rx Database, 2013 & 2011.)

“We believe that the vegan certification of our plant-based capsules would further help our supplement manufacturing customers enhance the attractiveness of their overall products to this ever-growing, targeted market,” Lowery remarked. “Our vegan-certified empty vegetarian can help our supplement manufacturing customers expedite their process of applying for vegan certification for their finished products.”

More Than Just a Symbol

There are still many “glass-half-empty” people who believe that certification symbols are merely marketing tools with no true merit or significance. To achieve non-GMO certification, FoodChain ID provides its Non-GMO Project Verification. According to Herous, this process begins with evaluating products in order to verify, or certify, that they are compliant with the requirements outlined in the Non-GMO Project Standard. The Standard’s core focus is on continual testing of high-GMO-risk inputs, supply chain traceability, obtaining inputs in accordance with uniform and meaningful specifications, accurate and clear product labeling, and maintaining operational consistency while addressing non-conformities in a prompt manner. “Being Non-GMO Project Verified with FoodChain ID signifies that a product has been produced in accordance with the best practices for GMO avoidance,” she said.

IFANCA provides full halal certification covering all consumables as well as personal care products and even vaccines; and it signifies that a product or ingredient meets the halal criteria required by Islamic law. In July, noteed Chaudhry, IFANCA introduced a new Five Star Halal Identification System to provide additional transparency on meat and poultry products. The system identifies that the slaughter person is Muslim, if the slaughter was performed using the traditional horizontal cut, if the animal or bird was fed an all natural diet of plant origin, if the slaughterhouse meets animal welfare guidelines, and if stunning was used prior to or after slaughter. This is relevant for bovine-sourced capsules, and other animal-based ingredients used in supplements.

According to Luther, NSF developed the only accredited American National Standard for Dietary Supplements (NSF ANSI Standard 173) more than 15 years ago. NSF offers a manufacturing facility GMP registration and two levels of product certification based on the requirements of this standard: NSF Dietary Supplement Certification and NSF Certified for Sport.

Manufacturing facilities can earn NSF’s GMP registration if they are successfully audited twice a year to verify continued compliance with GMPs specified in 21 CFR Part 111. Any issues of non-compliance to the GMP requirements must be addressed with corrective actions before the manufacturing facility is approved as NSF GMP Registered. Facilities that achieve NSF GMP registration are listed on NSF’s website so that they can be easily identified by those wishing to manufacturer a supplement in an NSF registered facility. The second level of product certification is the NSF Certified for Sport Certification program, which builds on the first program by also screening the product (on a per lot basis) for more than 200 athletic banned substances.

Exacting Assessments

Achieving a certification for your product and/or product line entails a complete dedication among the company culture. Each is time-consuming, and rejections may occur at any point, verifying that achieving such certification is indeed a worthwhile endeavor.

When it comes to halal, Choudhry asserted that the assessment “is very thorough.” The process begins with the completion of an application for halal certification. This is accompanied by a listing of all the products to be certified, the manufacturing facilities involved, the ingredients used in the products, and all plant chemicals and lubricants used in the process. You will also need to submit replicas of the product labels that will be used. All this is reviewed by IFANCA’s team of food scientists to ensure everything conforms to the halal requirements. If the review reveals any ingredients that do not conform, the team develops alternatives for the manufacturer. This is followed by an inspection of the manufacturing facilities and review of the process flow, HACCP procedures, warehouses, storage facilities, packaging and any associated activities. During this review, IFANCA reps meet with plant quality management to incorporate halal control points into the HACCP procedure, as well as educate plant staff about their responsibilities in conforming to the established Halal requirements.

“Items to be conscious of and be vigilant about include the chance of cross-contamination with non-halal items, particularly ingredients derived from animals and alcoholic beverages,” Choudhry explained. “If a plant is not producing halal certified products 100 percent of the time, procedures are implemented to ensure the halal integrity of the products is maintained from initial production to final shipping out of the facility.”

Rabbi Fogelman explained that to certify a dietary supplement as kosher is no different than any other product. For the supplement to be kosher, he asserts, it needs two factors: it must contain kosher ingredients, and it must be manufactured on kosher equipment, which means that no non-kosher supplements can be made with the same equipment. If it is, then the equipment must be thoroughly cleaned and purged from any residue of the non-kosher supplement it may have clinging to it.

“There are naturally kosher ingredients (such as produce-derived), ingredients that can never become kosher, such as shark cartilage, or ingredients that may or may not be kosher,” he explained. “For example, vegetable oil is kosher while oil from non-kosher animal fat is not.”

There are several steps to achieve and maintain product certification to the NSF Dietary Supplement program, according to Luther. First, the manufacturing facility must earn the NSF GMP registration that verifies compliance with GMPs as specified in 21 CFR Part 111; this requires ongoing monitoring via audits twice a year. Next, the product must be tested and reviewed annually. This includes a toxicology and label claim review to verify product formulation and label claims, and that what’s on the label is in the bottle, as well as contaminant testing to ensure there are no harmful levels of specific contaminants. This testing is required annually. If the product meets the auditing and testing requirements, it is then authorized to show the NSF dietary supplement certification mark on the bottle. Further, the product will be included in the listing of certified products on the NSF website.

To earn NSF Certified for Sport certification, the product must first meet the requirements of the general Dietary Supplement Certification Program (the facility must by audited to ensure compliance with GMPs and the product must undergo toxicology and label claim review and contaminant testing).

“Then, on a per lot basis, it also is screened for more than 200 athletic banned substances as determined by the U.S. and the World Anti-Doping Agencies, MLB, and NFL, among others. Once the product achieves certification, it is authorized to bear the NSF Certified for Sport mark in its label and added to NSF’s list of Certified for Sport products. The NSF Certified for Sport Certification program is supported by the NFL, NHL, MLB, PGA, LPGA, Canadian Centre for Ethics in Sport (CCES) and the New York City Police Department,” Luther said.

FoodChain ID’s Heroux explained, “guides manufacturers in mapping out the supply chain of the products they wish to have verified via the procurement of supplier/manufacturer documentation, which identifies the inputs and processes involved in the product manufacturing. We evaluate supplier documentation on all inputs including main ingredients, carriers, processing aids, flow agents, substrates, fermentation aids, enzymes, and others as well as require the biological sources of material in order to evaluate GMO-risk. Other required documents are detailed SOPs on handling, shipping and storage, clean-out, segregation, etc. The Standard requires we look in detail at the system products are manufactured in order to ensure said systems are designed to avoid GMOs.”

Ongoing Work

In addition to a document review, she noted, ongoing testing is required for many products and ingredients; a specialized sampling and testing protocol is developed for these and manufacturers work with a non-GMO-approved, ISO-accredited lab for the tests. FoodChain ID evaluates the results against the Standard’s requirements for action thresholds.

To achieve its vegan certification, Capsugel submitted a complete list of ingredients and included any processing aids used in manufacturing but not part of the final product, according to Lowery. “We confirmed with each vendor that no animal testing had been used and all non-GMO information was also confirmed. We further submitted information regarding our manufacturing process to ensure there is no cross-contamination of non-animal products with material of animal origin.”

She added that Vegan Action reviewed the products, accepted the application and approved use of the trademark for 12 months in the United States and Canada. Capsugel is now listed on the Vegan Action website, and it pays an annual licensing fee. Capsugel, Lowery noted, is responsible for notifying Vegan Action if the ingredients in any approved product should change.

Supplements without any certifications may get bypassed for those competitive products that do. Certifications also quiet the naysayers who repeat the myth that “supplements are not regulated by the FDA (U.S. Food and Drug Administration),” by proving that certification is achievement of safety and quality. NIE

For More Information:
Capsugel, www.capsugel.com
FoodChain ID, Inc., (866) 440-3242
IFANCA, (847) 993-0034
NSF, (800) 673-6275
OK Kosher, (718) 756-7500

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