USDA Implements National Organic Program

USDA Implements National Organic Program
Rules should bring clarity to foods, but what aboutsupplements?

WASHINGTON--On Oct. 21, more than 12 years afterthe passage of the Organic Foods Production Act (OFPA), the U.S. Department ofAgriculture (USDA) will fully implement the National Organic Program (NOP). Atits heart, the goal of the NOP is to establish organic standards and overseemandatory certification of organic production. At Natural Products Expo East inWashington, 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, thingswere quiet on the organic front in the dietary supplement aisles. While thereare some contract and branded-product manufacturers that have been certified byUSDA-accredited certifiers, it is a tiny minority. In fact, there has been agrowing question of how--and whether--the NOP regulations apply to the dietarysupplement industry.

NOP issued some guidance on the topic, but has not completelyclarified the issue. In its Policy Statement on the National Organic ProgramScope (issued May 2, 2002), NOP noted that because dietary supplements containagricultural products, producers and handlers are eligible to seekcertification; it is not required, but all ingredients represented as organicmust be produced and handled in compliance with the NOP. In a reply to questionsfrom 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 maybe used on [dietary supplement] products only when the entire product has beenproduced and handled in compliance with the NOP, including all the applicableprovisions." In its Scope document, USDA noted that regulations concerningdietary supplements could be considered in the future, but it did not respond toINSIDER's question regarding the possible timeline on promulgating suchrulemaking.

What does this mean for dietary supplement makers? Currently,for a product to carry an "organic" claim on the principal displaypanel, it is regulated by percentage of organic ingredients. They can be"100% organic," "organic" (containing more than 90-percentorganic ingredients) or "made with organic [stated ingredients]"(containing more than 70-percent organic ingredients). If a company is offeringa product containing certified organically grown echinacea extracted under acertified process in certified organic alcohol, that product could be labeled"100% organic." If it contains 70 percent or more organic ingredients,all remaining ingredients must not be produced with prohibited methods (such asirradiation), though it could contain synthetic or non-organic ingredients inthe remaining 30 percent weight.

The supplement industry is seeing companies exploring andpromoting organic certification. Eustis, Fla.-based U.S. Nutraceuticals, forexample, built its processing facility to comply with NOP guidelines and wascertified by FVO, a USDA-accredited certifier. Other manufacturers, such as GaiaHerbs and Synergy Production Labs, are offering both finished organicsupplements and contract services. Gaia Herbs, based in Brevard, N.C., wasrecently certified by USDA-accredited Oregon Tilth. According to Ric Scalzo,president, the company saw increased scrutiny of record keeping and labelingduring this year's audit, and had to stop doing business with some contractfarmers because they were not certified or didn't fit in the audit trail. Scalzosaid the company also went through a transformation in representing"organic" on product labels and which products can be marketed as suchon the principal display panel. The company will now offer 38 single herbs as"100% organic," while the remaining 32 will be used in formulas andonly labeled as organic in the ingredient listing.

"The process has helped us become more efficient andunified our standards, which is getting us ready for the upcoming goodmanufacturing practice [GMP] requirements," he said. "We believe inthe process and hope, ultimately, this will stimulate more interest in organicsupplements."

Mitchell May, Ph.D., chief executive officer of SynergyProduction Labs in Moab, Utah, has seen increased consumer and industry demandfor organic supplements. "I think that now is the time to get into thisarea, and I anticipate a lot of companies looking to work with contractmanufacturers to introduce certain certified organic products," he said.Synergy was certified by Quality Assurance International (QAI), and said therewere not too many changes to the process of certification, but there have beenchallenges along the road.

For example, NOP requires the use of organic ingredients if theyare commercially available, but has been unclear on the practicalities of therequirement. "What if there's not a steady supply, or if the form you wantis unavailable, or if the cost is prohibitive?" May asked. "I don'twant to make products without answers from USDA on some of these determinations,but at the same time, I have a production schedule."

Another issue under discussion is delivery systems. Liquids havean option of organic alcohol, while tablets containing excipients must ensurethose ingredients are less than 30 percent of the finished product. Petitionshave been submitted for hydroxypropyl methylcellulose for vegetarian capsules,but as of early October, no determination had been made on whether to allow thematerial as an approved synthetic. If a material, even if it is just forencapsulation, is a synthetic compound, it must be included on the National Listto be included in an "organic" product.

Another challenge facing both food and dietary supplementmanufacturers is the fact that as of early October, no countries had equivalencyor conformity agreements with the United States, though several were in thereview pipeline. This means, to be sold as certified organic, those ingredientsmust have been certified by a USDA-accredited certifier. The few independentorganizations in countries such as Switzerland, Germany and Brazil that havebeen accredited are a small portion of USDA's approximately 150 accreditedcertifiers.

Given issues such as different processing requirements anddelivery systems, many in the dietary supplement industry think it may benecessary for USDA to review different regulations for organic dietarysupplements.

"USDA needs to refine these regulations to accuratelyreflect the differences between industries," May said. "Each hasunique, different attributes that would make maybe 10 percent of the program notable to translate between industries."

Even those involved in the program see the possibility ofchanges. "USDA will continue to wrestle with issues such as dietarysupplements and whether they can carry organic label claims," said DaveCarter, chairman of the National Organic Standards Board (NOSB). "Questionshave come up, and the radar is tuned in that there is more than just food. Thereis pressure for uniform standards, which will probably mean morerulemaking."