Certifications Build, Enhance Consumer Confidence

Very few people could care less about what they put in their bodiesnamely 4-year-olds and college students. The rest of civilized society, however, can be more demanding in knowing whats inside the food they are eating or supplement they are taking. With so many dietary supplements on the market, customers are increasingly looking for ways to ensure they are getting what they pay for. Manufacturers and suppliers are also seeking ways to prove their products meet high-quality production and safety standards as a way to stay ahead of the competition. The nexus at which these two sides can come together is in product certification.

Waiting for the GMP

Probably the highest profile certification in the dietary supplement industryas much for its continued non-existence as what it could meanare the federal GMPs (good manufacturing practices) for dietary supplements. With the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, Congress specifically defined dietary supplements and ingredients, created quality assurance framework, issued guidance for communication and set rules for proper labeling. It also charged the Food and Drug Administration (FDA) with promulgating dietary supplement-specific GMPs, based off food GMPs, to help ensure product quality.

Fast-forward to the present day12 years laterand the federal government still hasnt issued final dietary supplement GMPs. FDA has repeatedly stated its GMPs have been submitted to the U.S. Office of Management and Budget (OMB), but a final ruling is still not on the horizon. The latest submission was to the OMB was made on Oct. 25, 2005. In response to INSIDERs inquiry, an FDA spokesman said, In essence, they [GMPs] are out of the FDA court.We have no information at this time as to when OMB will act and what that action will be.

However, the 12 years have not been without forward movement. Even as industry waited for federal GMPs, associations and independent organizations took matters into their own hands. For instance, in 1999, the Natural Products Association (then known as the National Nutritional Foods Association) developed its own GMP certification program to meet this need.

NPAs GMP program was developed with member suppliers and other trade organizations, as well as FDA. Since the programs start, NPA has certified more than 50 companies.To become certified, NPA briefs the applying company on the basics of GMPs, and then the company performs an initial internal GMP audit. The company then registers for the GMP program, selects a third-party auditor and schedules its independent audit. Auditors typically look into a companys facilities, personnel, quality control, warehousing, distributing and any other issues in the operation, verifying compliance to the established NPA GMPs.

The company must then complete corrective actions based on the auditor report, at which point the auditor will assign a rating and final report to the NPAonly companies with an A rating become GMP certified. The company will be officially certified once it signs a letter stating the terms of certification.

NSF International also developed an industry GMP registration program. NSFs GMP registration program for contract manufacturers and manufacturing facilities of dietary supplement companies enables contract manufacturers to become independently registered by NSF as complying with GMP requirements as listed in Section 8 of NSF/ANSI Standard 173-2003. NSF is accredited by the American National Standards Institute (ANSI) to develop American National Standards, which verifies NSF develops standards in a manner to ensure openness and due process allowing for equity and fair play.

According to NSF, independent GMP registration increases a companys credibility in the marketplace and provides advance preparation for the forthcoming federal GMPs. Further, NSF has a strategic alliance with NPA that allows NSF to accept the NPA GMP audit for contract manufacturers for initial qualification into the NSF GMP Registration Program.

Another up-and-coming program in the dietary supplement arena is ISO certification. The International Organization for Standardization (ISO) develops international standards in a wide range of industries, and those standards serve as the basis for various certification programs. ISO sets standards, but is not itself an auditor or a certifier of programs. ANSI takes many ISO guidelines into account and accredits independent third parties on specific certification functions. Another example of an ANSI accreditation program is its partnership with the Food Marketing Institute and the Safe Quality Food Program. Dietary supplements can be audited and certified by this internationally recognized organization as well.

Organic Standards

Consumers are also showing increased interest in products that are certified organic. Organic certification can add credibility and a competitive advantage in a rapidly growing market. In the late 1980s, the growing organic foods industry recognized the need for a level playing field and federal oversight of the term organic. With industry support, Congress passed the Organic Foods Protection Act in 1990. Over the following 15 years, the U.S. Department of Agriculture (USDA) promulgated regulations covering the specifics of organic production in the United States, and developed a system for accreditation and certification to ensure compliance.

Getting certified can be particularly lucrative because demand for organic product in the United States is steadily risingsales of organic foods have risen approximately 15 to 20 percent annually despite accounting for only 2.5 percent of the overall U.S. food market.

The Organic Trade Association lists three requirements for certification: (1) the methods and material used in production must meet organic standards; (2) there must be a clear and ongoing documentation of these methods and materials; and (3) there must be a paper trail tracing the product back to its production site in order to verify the methods and materials used in its production.

To become certified, the grower or handler of the organic product has to submit a farm plan or organic handling plan to a third-party auditor, who must be USDA approved. This plan has to include how the materials are handled and grown as well as any future plans for the organization.

In addition, any ingredients processing has to meet the national organic regulations, including compliance with the National List (www.ams.usda.gov/nop) of allowed synthetics and processing aids, which spells out which materials can and cannot be used. For example, certain nonagricultural substances are allowed, such as potassium chloride, camauba wax, ascorbic acid (vitamin C) and tocopherols (vitamin E).

Religious Appeal

Supplement certification is important on the secular side of things, but religious certification can also add an extra layer of thoroughness when it comes to an ingredients or products credibility. It also ensures that followers of certain religions can adhere to the sanctity of their beliefs.

In Judaism, kosher law governs what food can and cannot be eaten. Kosher laws originated in the Bible and are detailed in the Talmud and other codes of Jewish traditions. Non-kosher foods include certain types of animals, fowl and fishfor example, pork, rabbit, eagle and catfish. Shellfish, insects and reptiles also are not kosher. In addition, kosher meat and fowl must be slaughtered a certain way, and meat and dairy products cannot be manufactured or consumed together.

There has been growing awareness of the role of kosher compliance in the dietary supplement arena, as many ingredients are animal sourced or derived. For example, glucosamine, used to ease joint pain, can be vegetarian in origin, but is traditionally made from shellfish. Interestingly, shellfish shells can be kosher, but only under specific conditions and oversight. The shell is essentially made of up of minerals and proteins andif completely free of flesh and dried properlyis not considered part of a forbidden creature because the shell is inedible. However, if the supplement is derived from a soft shelllike shrimpit is not kosher because the shell is edible and the taste of flesh remains on the shell.

The Orthodox Union (OU), founded in 1898, is the worlds largest kosher certification agency and is widely known by its symbol found on labelsa U within a circle. This symbol appears on more than 400,000 food and food-related items in United States alone, and many consumers look to this symbol to make purchasing decisions.

Kosher certification involves questions regarding ingredients as well as processing equipment. Submitting logistical information about manufacturing processes and ingredients to be certified is the first step. Next, a Rabbanic Coordinator (RC) is assigned to handle the application, and a Rabbanic Field Representative is sent to observe the manufacturing process. The RC reviews the application and inspection report and decide whether to grant kosher certification. Once the contract is signed, the company can begin to use the U symbol on its labels.

Another religion-based certification is Halal, which means proper and permitted in Arabic. This word also describes the foods and products that meet the dietary requirements of Muslims. Halal certification dates to the early 1980s when American fast-food restaurants started opening in the Middle East and Southeast Asia.

The Quran defines Halal as foods lawful for a Muslim to eat. Unlike Kosher law, there is no issue in keeping meat and milk ingredients apart from each other. However, meat and poultry must be slaughtered by a Muslim and a blessing must be said during the process. The blessing must be said in person and cannot be duplicated by a recording.

Contrary to Halal, Harem means prohibited or forbidden and describes foods or supplements that are not made using Halal standards. Harem foods include alcohol, pork and pork by-products, in addition to animals that have talons and/or fangs and birds that prey on the flesh of dead animals.

One of the leading U.S. Halal certifiers is the Islamic Food and Nutrition Council of America (IFANCA). Run by food scientists and Islamic scholars, IFANCA looks at supplements the same way as food; like any other certification program, Halal inspectors look at every process the supplement goes through to be made. For instance, gelatin used in supplements must come from animals that have been slaughtered using Halal standards.

During Halal certification, IFANCA auditors inspect the facility and review the products suppliers and ingredients.A sanitation review and plant inspection details the products quality control and storage. Production processes are also reviewed and equipment is checked for any cross-contamination from non-Halal products. After the inspection, if Halal certification is granted, the company can use the Crescent M Halal logo on its product labels.