Washington—On October 21, more than 12 years after the passage of the Organic Foods Production Act (OFPA), the U.S. Department of Agriculture (USDA) will fully implement the National Organic Program (NOP). At its heart, the goal of the NOP is to establish organic standard and oversee mandatory certification of organic production. At Natural Products Expo East in Washington, D.C., earlier this month, the food industry celebrated the NOP, introducing new products and showing packaging with the USDA organic seal.
Even as the food industry celebrated its new products, things were quiet on the organic front in the dietary supplement aisles. While there are some contract and branded-product manufactures that have been certified by USDA-accredited certifiers, it is a tiny minority. In fact, there has been a growing question of how—and whether the NOP regulations apply to the dietary supplement industry.
NOP issued some guidance on the topic, but has not completely clarified the issue. In its policy statement on the National Organic Program Scope (issued May 2, 2002), NOP noted that because dietary supplements contain agricultural products, producers and handlers are eligible to seek certification; it is not required, but all ingredients represented as organic must be produced and handled in compliance with the NOP. In a reply to questions from INSIDER, NOP representatives noted, “Using the term ‘organic’ on the principal display panel of [dietary supplement] products is, at present, outside the scope of the NOP.” However, they added, “the USDA seal may be used on [dietary supplement] products only when the entire product has been produced and handled in compliance with the NOP, including all the applicable provisions.” In its Scope document, USDA noted that regulations concerning dietary supplements could be considered in the future, but it did not respond to INSIDER’s question regarding the possible timeline on promulgating such rulemaking.
What does this mean for dietary supplement makers? Currently, for a product to carry an “organic” claim on the principal display panel, it is regulated by percentage of organic ingredients. They can be “100% organic,” “organic (containing more than 90-percent organic ingredients) or “made with organic [stated ingredients]” (containing more than 70 percent organic ingredients). If a company is offering a product containing certified organically grown Echinacea extracted under a certified process in certified organic alcohol, that product could be labeled “100% organic,” If it contains 70 percent or more organic ingredients, all remaining ingredient must not be produced with prohibited methods (such as irradiation), though it could contain synthetic or non-organic ingredients in the remaining 30 percent weight.
The supplement industry is seeking companies exploring and promoting organic certification. Eustis, Fla.-based U.S. Nutraceuticals, for example, built its processing facility to comply with NOP guidelines and was certified by FVO, a USDA-accredited certifier. Other manufacturers, such as Gala Herbs and Synergy Production Labs, are offering both finished organic supplements and contract services. Gala Herbs, based in Brevard, N.C., was recently certified by USDA-accredited Oregon Tilth. According to Ric Scalzo, president, the company saw increased scrutiny of record keeping and labeling during this year’s audit, and had to stop doing business with some contract farmers because they were not certified or didn’t fit in the audit trail. Scalzo said the company also went through a transformation in representing “organic” on product labels and which products can be marketed as such on the principal display panel. The company will now offer 38 single herbs as “100% organic,” while the remaining 32 will be used in formulas and only labeled as organic in the ingredient listing.
“The process has helped us become more efficient and unified our standards, which is getting us ready for the upcoming good manufacturing practice [GMP] requirements,” he said. “We believe in the process and hope, ultimately, this will stimulate more interest in organic supplements.”
Mitchell May. Ph.D., chief executive officer of Synergy Production Labs in Moab, Utah, has seen increased consumer and industry demand for organic supplements. “I think that now is the time to get into this area, and I anticipate a lot of companies looking to work with contract manufacturers to introduce certain certified organic products.” He said. Synergy was certified by Quality Assurance International (QAI), and said there were not too many changes to the process of certification, but there have been challenges along the road.
For example, NOP requires the use of organic ingredients if they are commercially available, but has been unclear on the practicalities of the requirement. “What if there’s not a steady supply, or if the form you want is unavailable, or if the cost is prohibitive?” May asked, “I don’t want to make products without answers from USDA on some of these determinations, but at the same time, I have production schedule.”
Another issue under discussion is delivery systems. Liquids have an option of organic alcohol, while tablets containing excipients must ensure those ingredients are less than 30 percent of the finished product. Petitions have been submitted for hydroxypropyl methylcellulose for vegetarian capsules, but as of early October, no determination had been made on whether to allow the material as an approved synthetic. If a material, even if it is just for encapsulation, is a synthetic compound, it must be included on the National List to be included in an “organic” product.
Another challenge facing both food and dietary supplement manufacturers is the fact that as of early October, no counties had equivalency or conformity agreements with the United States, though several were in the review pipeline. This means, to be sold as certified organic, those ingredients must have been certified by USDA-accredited certifier. The few independent organizations in countries such as Switzerland, Germany and Brazil that have been accredited are a small portion of USDA’s approximately 150 accredited certifiers.
Given issues such as different process requirements and delivery systems, many in the dietary supplement industry think it may be necessary for USDA to review different regulations for organic dietary supplements.
“USDA needs to refine these regulations to accurately reflect the difference between industries,” May said. “Each has unique, different attributes that would make maybe 10 percent of the program not able to translate between industries.”
Even those involved in the program see the possibility of changes. “USDA will continue to wrestle with issues such as dietary supplements and whether they can carry organic label claims,” said Dave Carter, chairman of the National Organic Standards Board (NOSB). “Questions have come up, and the radar is tuned in that there is more than just food. There is pressure for uniform standards, which will probably mean more rulemaking.”