The Organic Factor

In a modern world concerned with status, titles and designations, companies often seek various certifications as indications of quality, both real and perceived. While GMPs have been derigeur for many supplement companies of late, perhaps no voluntary certification has been more popular than organic.

“Although on the manufacturing side, there are many more certifications that are more rigorous and specific with regards to quality systems, they are confusing and beyond comprehension for the average consumer,” said Alex Moffett, president of Renaissance Herbs, now known as Avesthagen Inc., which earned organic certification in early 2007 for processing two botanical extracts. “The organic seal is at the top of the heap with regard to perceived quality for consumers.”

But does organic necessarily equal higher quality? This depends on the definition of “quality.” A recent four-year European Union (EU) study revealed some organic foods have higher nutritional content than their non-organic counterparts. The study, part of the Quality Low Input Food (QLIF) Project, showed organic fruit and vegetables contain as much as 40 percent more antioxidants than non-organically grown produce, while organic milk contains between 50 and 80 percent more antioxidants than conventionally produced milk; results showed organic milk also contains more vitamin E. Carlo Leifert, lead study author and professor at Newcastle University’s Tesco Centre for Organic Agriculture, England, remarked the results suggested eating organic food would be equivalent to eating an extra portion of fruit and vegetables a day.

“The organic guarantee is based on an agricultural methodology and defined in a federal regulation,” said Joe Smillie, senior vice president of Quality Assurance International (QAI), an organic certifier. “It is not a health or safety claim but many people, and an increasing body of science, believe there are health and safety benefits.”

While such research findings translate most directly to produce-based products, it indicates the real likelihood plants and subsequent finished goods produced organically maintain higher content of beneficial compounds. Only continued research will show whether this bears fruit for herbs used in organic supplements and personal care products.

There are other aspects of organic certification that relate to quality control. Viella Shipley, marketing director for California Cer tified Organic Farmers (CCOF), an NOP-approved organic certifier, stated the absence of pesticides and residues in certified organic goods definitely equates to higher quality. She noted organic products still have to go through the same FDA regulations and controls as conventional products, such as controlling lots and lot numbers, as well as food safety measures. “Organic products don’t get separate treatment from FDA but may be subject to further restriction by NOP regulations,” she said.

Moffett explained that organic raw materials don’t always pass QC tests. “As with foods, the material needs to possess an organic certification, but additionally, that material must pass our specifications for high levels of the desirable photochemical constituents in addition to having low levels of heavy metals and be free of pesticide contamination,” he said. “As an example, our factory recently rejected a lot of certified organic Tulsi basil. While it was indeed organic, it was a low quality product with low levels of ursolic acid and also contained higher than acceptable levels of heavy metals.”

Organic certification and compliance involves regular inspections, not just of physical fields and plants, but also of documentation and procedures. Shipley called the certification process an audit trail involving thorough inspection and analysis of all parameters of an organic operation. Certification is not a one-time process, as Shipley noted CCOF usually audits clients once a year, unless other factors warrant more frequent inspection. During their visits, certifiers will thoroughly inspect the books, as well as physically inspect fields and facilities, including soil condition, processing, equipment and personnel.

Adding ingredients or new components to a certified organic production is one reason for increased inspection. If this is the case, the client is expected to update their plans and certifications, notifying the certifier of the changes. “If we go to an inspection and notice new ingredients that were not noted prior, the client is then in non-compliance,” Shipley said. “We can drop in whenever we want, and we get full access to all facilities.”

For companies upstream from the source or grower, the suppliers or growers used must be certified organic by approved NOP-entities, supported by appropriate documentation. Shipley noted this also brings transport into the equation, including cleaning logs for equipment and machinery involved.

Paul Shulick, founder of New Chapter, the first vitamin manufacturer to go organic, said the process was “very challenging, especially when it came to the strict limits placed on ingredients used in organic.” Trying to find organic ingredients led the company on a global search for sources.

Despite the challenge and volume of work involved, companies with extensive QC programs in place might find the organic process a bit easier. “If a company has good quality control standards in place, it is really not difficult for them to implement organic standards, because the two protocols are similar,” Shipley reasoned. She concluded in terms of record-keeping and process, organic demands a company maintains current QC levels of control, plus another level, especially in cases of co-production of both organic and non-organic products. “Because we strictly adhere to current GMP regulations and are audited regularly by NSF, as well as many of our customers, the QAI organic certification process went smoothly,” confirmed Kirk Neal, vice president of operations at Arizona Nutritional Supplements.

QC and organic also overlap in terms of duties. In larger corporations, certifiers often see, and prefer, a division devoted to organic compliance. But, in many companies, organic compliance may fall under the responsibility of the QC department. “Organic certification is a responsibility for our QC compliance staff,” Moffett noted.

New Markets, New Challenges

The organic market is ever-expanding into areas beyond simple foods. The OTA’s 2007 Manufacturer Survey revealed U.S. sales of non-food organic products grew from $744 million in 2005 to $938 million in 2006, a 26 percent increase. This includes organic supplements, personal care products, household products and cleaners, pet food, flowers, and fiber products such as linens and clothing. OTA previously reported organic dietary supplements had about $238 million in U.S. retail sales in 2005, a 29 percent increase over 2004 sales.

As supplements were historically regulated as foods, and are still regulated as a subset of foods rather than of drugs, there has been speculation about certifying supplements as organic. “In an August 2005 memo, the USDA allowed the organic seal to be used on supplement and personal care products, but they must meet all food standards,” Smillie noted. “This is difficult, because many of the materials used, although non-toxic and benign, are not on one of the national lists; veggie caps containing methyl cellulose are a good example.” Neal added currently only tablets or powder supplements are capable of getting the USDA Organic certification due to the lack of an organic certified capsule on the market.

Ronnie Cummins, national director of the Organic Consumers Association (OCA), said: “As a watchdog of organic standards, we were able to reach a temporary settlement with USDA to not allow its seal on non-food product unless certified according to USDA food standards. Thus, you can find food-grade organic body care, pet food and supplements, but these products are still few and far between.”

According to Holly Givens, public affairs advisor for the Organic Trade Association (OTA), organic dietary supplements and functional foods are regulated under the handling section of the rule, section 205.605 of the USDA NOP regulations. In short, the agricultural ingredients in a supplement must meet the NOP requirements. Givens reported a product must contain at least 70-percent organic ingredients, excluding water and salt, in order to use the word “organic” on the principal display panel. With this level of organic labeling, the product can list up to three ingredients as organic: “Made with organic X, Y and Z.”

Beyond that level, products with 95 percent or more organic ingredients can be called “organic,” and can feature the “USDA Organic” seal on the packaging/label. In these products, agricultural ingredients must be organic, if available, and non-agricultural ingredients and/or non-organic agricultural ingredients must be on the approved National List of Allowed and Prohibited Substances. “If a supplement or functional food requires stabilizers and other substances not on the national list, then we can’t certify it,” Shipley stated. “We tell these clients, ‘If your product meets USDA standards as it is now, you can certify it organic,’ which basically means they have to use food-grade product.”

This list of approved substances has been a controversial issue since the NOP regulations went into effect in 2002. In 2005, Maine organic blueberry farmer and NOP inspector Arthur Harvey filed a suit against USDA, alleging NOP’s exemption of non-organic substances was too broad and against the original tenets of the Organic Food Production Act (OFPA) of 1990. Losing the original case, Harvey won important points on appeal, including: permitting the use of a non-organically produced agricultural product only when the product is on the National List and when an accredited certifying agent determines the organic form of the agricultural product is not commercially available. While many people reacted as though USDA is opening the doors for non-organic substances, many organic insiders countered the amended rule actually tightens restrictions on using non-organic compounds.

The Accredited Certifiers Association (ACA) stated: “Although it would appear that the listing of 38 non-organic, agricultural ‘minor’ ingredients to the National List is an expansion of what is allowed, it actually reduces the number of such ingredients that may be allowed. ... Prior to the new interim rules publication, organic processors could use ANY non-organic agricultural ingredient they needed, at less than 5 percent of an organic product, provided they could document that it was not commercially available in organic form. While 38 new items on the list may sound like a lot, it is a very short list compared to the thousands of possible ingredients that are now prohibited.”

Shipley agreed, adding the restricted list pushes the market. “These compounds are not accepted forever, but get reviewed every five years,” she said. “It forces the industry to find alternatives, but keeps the market going during that time. Some substances will come off as substitutes are found or developed.”

In the case of personal care products, she said a similar list is under development for body care ingredients, as certain common additives in those products are not on the National List. “There is a movement and committee that have come together to help set organic standards for body care products,” she reported. For now, personal care companies are in the same boat as supplement companies—the ingredients and carriers, stabilizers and other processing aids must be approved for organics. “If the carrier is an essential oil with an essence added, that can be certified,” she explained. Moffett added the unanswered issues these last few years over hydrosols in personal care products have been a major stumbling block.

Personal care companies often mistakenly think that meeting organic requirements in Europe, where personal care products have specific standards, means certification in the United States is transferable or easy. NOP-approved cer tifiers repor t the process for personal care can be more difficult, given the lack of specific standards.

The international comparison of organic standards is important, as companies are increasingly operating in a global theater. As is the case in QC, regulations differ from region to region, country to country. The NOP has and can accredit certifiers in other countries to inspect and certify growers. U.S. certifiers report a good deal of interest from companies with products featuring exotic berries, such as açaí, which is grown in Brazil. Those companies would need to provide U.S. certifiers certificates showing their growers were inspected and certified by an NOP-approved entity. This is how it works for companies sourcing from or exporting to countries like Brazil or China, or in places with more established organic regulations like Europe or Canada.

The European Union is in the process of updating its organic regulations, and Canada is developing a national program, similar to how the United States did. Europe seems particularly concerned about GM (genetically modified) ingredients, in addition to frowning upon co-production, having both organic and conventional products made and/or handled by the same company or location. NOP allows co-production, provided companies can ensure no cross contamination or co-mingling occurs, and the company keeps meticulous paperwork on its organic operations.

While it seems, at first glance, Europe has stricter organic regs, the United States is stricter on things like requiring organic feed for certified organic cows, which Europe does not require. Longtime U.S. certifiers tend to advocate stricter regulations in the NOP, including restricting GMOs, limiting non-organic spraying and requiring growers groups to undergo 100-percent inspection, versus the current rule requiring only 20 percent of growers in a group be inspected.

For companies operating and exporting into Canada, voluntary national organic standards in place since 1999 have undergone official revision and are slated to soon become a national regulation in same vein as the USDA NOP. The new Organic Products Regulation (OPR) details organic agricultural certification requirements, including a national list of approved non-organic compounds and a program logo, in two languages: “Canada Organic” and “Biologique Canada”.

In the end, organic certification does not necessary equate to high-end QC, but it does indicate a commitment to higher standards and higher-quality goods relative to nutrients and contaminants. It does not directly address issues of identification and purity, but any grower, ingredient supplier or finished product manufacturer seeking to gain organic certification will already be required to operate under GMPs, whether for foods or supplements. Going organic takes all the record-keeping and process controls a few steps further. “If someone is unfamiliar with our company, having our organic certification, along with our NSF and NPA GMP certifications and our UNPA membership, certainly helps to set their mind at ease and lets them know that we care about quality,” Neal said. 

The Quality Control section is sponsored by Ethical Naturals; however, the company does not review or approve editorial content.