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Cultivating Consumer Confidence Through Safety and Efficacy

AIDP

As consumers have become increasingly educated to the variance of safety measures in supplements, the greater assurances they require that brands—beginning with ingredients— be held to the highest quality standard

The nutritional consumer is by definition a more health conscious consumer and as such has an even greater interest in knowing the product they are purchasing to improve their health is of the highest quality. But as the recession upped the ante on consumers seeking out nutritional products— realizing the health care system has left most in their wake to sink or swim—it has intensified criticism of the dietary supplement industry and thrust ingredient safety and efficacy to the forefront.

“I think it is fair to say that the dietary supplement industry has come under attack by the mass media, with the industry described incorrectly as ‘unregulated and out of control,’” said Larry Robinson, PhD, vice president of scientific affairs with Embria Health Sciences, LLC (Ankeny, IA). “Enforcement of regulations by the FDA will remove those few companies that have caused the media to question our industry as a whole. It is extremely important that our industry has products that are first of all safe, but also proven to be effective. Efficacy is second in importance only to safety.”

Safety Starting Point

Where certificates of analysis (CoA) were once the standard for manufacturer assurance that the ingredients they were receiving were what they expected, with the intensified industry scrutiny, the established good manufacturing practices (GMPs) have set a new standard to both improve quality and demonstrate to the public that this industry offers the highest quality products.

“It is no longer uncommon to see companies in the food industry touting that their products are made in a facility that adheres to current good manufacturing practices (GMP). That is not marketing hype. It refers to an FDA-registered facility where the company has invested in processes and procedures to ensure accurate and repeatable results, and where problems are identified early and corrective action plans are in place to ensure they do not recur,” said Tina Sturgill, site director for Celsis Analytical Services (St. Louis, MO and Edison, NJ), a contract lab that offers a full range of microbiological, chemical and stability testing for raw materials and supplements.“With the very real threat of regulators shuttering your facility, companies owe it to their future to use an FDA-registered lab that is going to follow testing methods that will stand up to scrutiny.”

Deerland Enzymes (Kennesaw, GA), like most companies that have completed the exhaustive process of attaining GMP certification, expressed pride in its investment as well as warning that manufacturers not looking for it in their ingredient partners do so at their own jeopardy.

“GMP certification is about creating an even starting point, not a finishing point. It’s a minimum standard, not the maximum that companies should be providing,” added Tod Burgess, vice president of sales with the company.“The GMPs bring a level of legitimacy and show an investment in quality is extensive. These new regulations are a way of thinning out the herd.”

“GMP certification is not a mark of ethics, it shows suppliers have SOPs in place in addition to testing that assures a manufacturer is getting what they’re asking for,” added Scott Ravech, Deerland’s CEO. “Be it through NSF or NPA, companies are spending hours as well as dollars on equipment, processes and people. There’s a certain burden of risk that companies are opening themselves up to if they’re not insisting upon GMP certification from their partners.”

The Root of Efficacy

Identity and purity of ingredients are Key factors for Ayush Herbs Inc, (Redmond, WA), an ingredient supplier to the nutraceutical industry for more than 20 years, which manufactures its own extract through Ayush Herbs Private Limited, India.

“One of the most important factors about Ayush is that it uses the right species and proper identification of the herbs for extraction. In-house testing of the ingredients and standardization of the sample is confirmed after the extractions are complete,” said Dr. Shailinder Sodhi, president of Ayush Herbs. “These are very important steps to assure the quality of the ingredients has met the standards. Products are effective in showing the results if the proper species and extractions are done accordingly.”

Sodhi explained that his company has kept its focus on research and development of new and improved technology for better extraction at the forefront, and is committed to continue this process.

Nutrition Formulators Inc. (Miramar, FL), maker of AstraGin™, boasts a recent investment that has further enhanced its testing capabilities. “Our focus the past two years has been on identity and purity,” said Brian O’Neill, the company’s business development manager, adding that this year the company has added 1,800 square feet of lab space to keep up with the demands of its certifiers and customers. “While we see a need to control efficacy, in the end, these can be proven with solid foundations of identity and purity in most of the products we make.”

Similarly, National Enzyme Company (NEC, Forsyth, MO) brought Sora Laboratories, LLC into its family of companies, which has added 600 square feet of space for in-house laboratory testing. According to Demitrius Bledsoe, director of marketing, the new laboratory houses new instruments, which includes but is not limited to the ICP-OES, GC-MS, HPLC-DAD, UPLC, FTIR and ELISA. “These state-of-the-art instruments offer identity, quality and potency testing in-house at NEC which is of great benefit to our customers and potential prospects,” he said.

Deerland Enzymes has also been increasing its investment in technology advancements and testing efforts, and those efforts have been greatly enhanced by John Deaton, the company’s director of research and development.

Ravech credits Deaton with implementing specific techniques at Deerland, which help further differentiate the company. These techniques are not restricted to the ingredients, but also apply to the equipment. For example, Deerland swabs and tests every surface of its machinery for a protein presence, and it won’t release equipment for use until it’s been signed off on.In addition, Deaton has implemented quarantines of materials—from ingredients to bottles and packaging—that ensure no contamination taints the finished product. And then, as an added measure, the company tests again.

“Before a finished good is shipped, we test everything again routinely for potency, identity and microbial growth,” said Ravech. “We’re spending more money making certain the products our customers are buying are free from contamination.At a time when the recession may have motivated certain suppliers to cut back or do less, we’ve put the processes in place and continued to push forward to ensure quality.”

Third-Party Testing

For some suppliers and manufacturers, having an outside source confirm the purity and efficacy of their goods is the ultimate testament for customers. One such company, Avanti Polar Lipids (Alabaster, AL), provides analytical testing for raw material and formulation providers of lipid related materials. In doing so it confirms the quality and/or content of materials—information that is critical in supporting label claims and shelf life. “We have had a substantial increase in these activities over the last 12 months due to cGMP requirements,” said Jeff D. Moore, PhD, analytical technology director with Avanti.

“Manufacturers are keen and competitive to meet their label claims, especially when a product may contain higher content of a recognized beneficial compound such as DHA, phosphatidylcholine or phosphatidylserine.”

ZMC-USA, LLC (The Woodlands, TX) conducts safety and toxicity studies through recognized third-party labs to ensure purity and safety of the ingredients it produces. Additionally, it supports clinical trials designed to evaluate the benefits derived from the many products it provides.

“ZMC was fortunate to have established a commitment to third-party certification and assurance of quality before the food safety issues which emerged within the past couple of years came to the forefront of consumer awareness,” said Scott Steinford, ZMCUSA’s president. “While many ingredient suppliers are still relying on the previous system of internal quality control, ZMC has taken the position as an industry leader to demonstrate our quality control and processes are not simply verified internally, but through respectedThird-party certifications such as the USPIV program, HACCP, ISO 14001 and ISO 22000. These highly regarded verifications assure our customers the process, and not simply the product, meet the highest standards of quality assurance.”

ZMC provides a comprehensive website which details its third-party certifications and inspections. Additionally, it works closely with organizations such as USP to continually develop testing procedures and standards, which result in a stricter regimen of identification. The company also encourages the audits and inspections by its customers of its manufacturing facilities to provide the highest level of customer assurance.

Ecuadorian Rainforest (Belleville, NJ) is another company that has regular contact with reliable third-party laboratories, which, according to Steve Siegel, vice president, is imperative in this heavily scrutinized climate.

“We believe that it is up to companies to combat the skepticism surrounding the dietary supplement industry by adopting strict quality assurance standards,” said Siegel. “Our products are sent weekly to reliable third-party laboratories for testing and analysis:

Advanced Laboratories, Inc. for microbiological analysis in detecting any abnormalities in the ingredients, and Alkemists Labs for HPTLC services, which are used to accurately identify an ingredient by using various solvent systems to separate and match the patterns of a compound against comparable indicators.”

Trials

Beyond verifying the identity and purity of ingredients, efficacy must be determined through laboratory or clinical studies whereby health and disease prevention claims are proven through administration of the product to animal or human subjects, according to Celsis’ Sturgil. While these results are beneficial for manufacturer partners, the ultimate hope is that this evidence can win over the end user.

According to Nena Dockery, scientific and regulatory affairs manager with NEC, the bare minimum evidence of efficacy for an ingredient comparable to other similar, well-researched ingredients is in vitro or animal data. But most manufacturers aren’t looking to put their marquis brand in the hands of the bare minimum, and Dockery pointed out that soon that might not be an option.

“Currently there is considerable industry discussion regarding efficacy substantiation and at some point, it is very possible that the FTC will require two double-blind, placebo-controlled, human clinical trials, not just on an ingredient, but on the finished product,” she explained. “The ‘gold standard’ would be a base of human clinical substantiation and ongoing human studies that reinforce the efficacy of an ingredient or exclusive blend of ingredients.”

Embria’s Robinson admits that this can pose a challenge for the dietary supplement industry, as supplements can’t be touted to treat or prevent, but his company has proven it’s not an insurmountable challenge with its flagship ingredient EpiCor.

“This means that subjects in any Human clinical trial should be healthy.However, as we have shown with our product EpiCor, a healthy population can be used in human clinical studies to demonstrate product efficacy,” said Robinson, who explained that the company was able to show that EpiCor supported the body’s immune system to keep it in balance, thereby letting the body’s immune system reduce the duration and incidence of cold and flu symptoms and reduce symptoms associated with seasonal allergies. These were all double-blind, placebo-controlled clinicals published in peerreviewed journals.

While these types of human clinicals are expensive, Robinson expressed that it’s a worthwhile investment, especially in terms of combating industry criticism.“Human clinicals are required to substantiate structure/function claims.Other forms of research, such as in vitro studies, are important and can add understanding to mechanisms of action, but cannot substitute for human clinicals,” he said. “Although large, doubleblind- placebo controlled clinicals are expensive, and when done correctly and published in well-respected peerreviewed journals, both consumers and regulatory authorities can then have the assurance that the product is effective.In addition, this is the only way to remove the ‘placebo effect’ that has been well documented in the literature.”

In these trials, Robinson explained that Embria prefers, when practical, that the measured end-point be a clinical outcome (e.g. symptom reduction) rather than change in biomarkers, as the symptoms are what the consumer cares about. But ultimately the research must be published “in peer-reviewed, Medline-listed journals so they can be scrutinized by the scientific community and are available for public review.”

Communicating Value

Publishing for public consumption is one key Embria credits with marketing success for those manufacturers who team with the company, in addition to the recognizable mark of a branded ingredient.

“As a branded ingredient manufacturer, Embria Health Sciences makes it easy for manufacturers and consumers to research EpiCor and the company itself,” said Cheryl Sturm, marketing director. “Use of a branded ingredient on the front of packaging makes it easier for consumers to choose products in very cluttered categories. EpiCor is also very easy to research online, where information is readily available in layman’s terms.”

Similarly, Pharmachem Laboratories, Inc. (Kearny, NJ) boasts more than 30 entries in its flagship ingredient’s—Phase 2 Carb Controller—safety, science and applications dossier. It is also the only weight control ingredient of its type with two structure/function claims, which can be invaluable to a manufacturer seeking to gain attention in a crowded—and often questioned—category.

Over the last several years, Pharmachem has invested in ingredient Branding programs to both the trade and consumer audiences. These campaigns, according to Skop, distinguish its brand from others, by creating awareness of the brand’s clinical study backing, efficacy and safety.

“Consequently, manufacturers can capitalize on the brand equity we’ve created by prominently displaying the brand logo and promoting in the marketplace,” he said. “In addition, we believe many of our ingredients offer unique benefits to the consumer, quality being the No. 1 benefit. We take tremendous pride in our analytical operating procedures, good laboratory practices, clinical data and so on. Each specialty ingredient offers a promise that, if responsibly stated, it can deliver on.”

Delivering as Promised 

Using branded ingredients is a great way for a product to stand apart from others on the shelf, especially when an ingredient supplier has gone to lengths to promote that ingredient directly to the consumer. But as NEC Scientific and Regulatory Affairs Manager Nena Dockery explained, suppliers must be just as diligent with their brands as finished product manufacturers.

“Ingredient suppliers and finished product manufacturers will often promote an ingredient based upon the ingredient’s proven efficacy under specific usage conditions, but will sell that ingredient without demanding that the conditions be met.Manufacturers will then formulate the ingredient into finished products in ways that were unintended by the ingredient developer/supplier,” she said. “Of course, this is a disservice to the end consumer, who often simply looks on a label for the presence of an ingredient, and doesn’t know how to verify that the ingredient dosage or other usage criteria are met in the finished product.
From an efficacy standpoint, it would be most beneficial to the end-consumer if there were strict guidelines regarding how ingredients are utilized in finished products to ensure that optimum efficacy is reliably achieved.”

Embria has strict requirements for use of its EpiCor trademark and requires that only companies whose standards meet Embria’s own may use the trademark.
For Pharmachem, Mitch Skop, director of new product development, explained that his company uses licensing agreements that delineate parameters for use of its ingredients, including permissible claims, regulatory and logo usage. “We also routinely test consumer products to make sure the integrity of the Pharmachem name and reputation remain intact.”