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October 1, 2013
For many dietary supplement manufacturers, the organic marketplace promises big sales, growth and, usually, confusion.
However, a recent partnership between QAI (Quality Assurance International) and the American Herbal Products Association (AHPA) simplifies the complex rules behind organic labeling in its guidance document, Guidance on Formulation and Marketing of Organic Dietary Supplements Under the National Organic Program."
Released on Sept. 4, 2013, the 15-page whitepaper outlines the types of dietary supplements available for organic certification, manufacturing procedures for compliance and common certification issues manufacturers face.
The idea for an organic guidance document originated a few years ago with an AHPA member committee request. The trade association then joined forces with QAI, a leading organic certification organization and NSF International subsidiary, to create the resource approximately six months ago.
And the timing couldnt be better, as consumer spending gains momentum and manufacturers have the confidence to branch out into a burgeoning organic marketplace.
Companies are ready to innovate and create new lines, so were seeing a lot of interest to formulate to organic," said QAI general manager Jaclyn Bowen, one of the projects leaders. But its not easy."
As a result, AHPA and QAI came together to create a Cliffs Notes-style cheat sheet for formulating dietary supplements to organic standardsuseful for quality assurance (QA), marketing and regulatory affairs departments alike.
Dietary supplement companies and food and beverage manufacturers must follow the regulations established by USDA's National Organic Program (NOP).
Published in 2000, the final NOP rule stated labeling dietary supplements was outside the scope of these regulations." However, the program revised its stance in 2005, announcing any raw or processed agricultural product meeting NOP standards could be labeled and marketed as organic.
Because USDA doesn't have regulatory responsibilities for dietary supplements, it didn't have to consider the industry as the regulations were being developed," said Jane Wilson, AHPAs director of program development. As a result, supplement and personal care companies found it difficult to break into the organic sector. Those industry segments werent around the table initially when we started focusing on the development of the NOP," Bowen added.
But organic is not just a food issue anymore. U.S. sales of organic dietary supplements reached $739 million in 2011an 8.5-percent jump from 2011according to the Organic Trade Association (OTA).
Consumers are demanding organic options across all segments, and smart supplement manufacturers are supplying the products.
A lot of companies are seeing the continued growth of the organic market," Wilson explained. If it's not a market they're already in, they may be considering how to enter it and take advantage of the fact that consumers want organic products."
But first, they must understand the intricacies of the NOP guidelines for formulation and labeling.
Tools for Certification Challenges
Dietary supplement manufacturers need to understand the limitations they have within the NOP," Bowen said, and the toolbox they can resource when formulating a product to meet organic rules."
The living document educates readers in five key areas: background on the NOP; labeling of products as organic; how dietary supplements can meet the standards; the organic certification process; and common certification issues.
As a certification body, every day QAI sees the challenges supplement companies face when formulating supplements to organic standards. AHPA, on the other hand, hears the struggles on a grassroots level from its member companies.
While teas, tinctures and other single-ingredient products may complete the organic certification process with ease, dietary supplements face hardship due to one particular noncompliance: utilizing technical additives and processing aids. In order to qualify for an organic claim, products additives and processors must meet one of three criteria, as outlined by the QAI/AHPA guidance document.
Appear on the non-agricultural materials National List (7 CFR 205.605), such as flavors, stabilizers and preservatives;
Appear on the non-organic agricultural materials National List (7 CFR 205.606), such as colors, gelatin and starches; or
Are other agricultural ingredients for products making a made with organic..." claim.
Wilson explained many dietary supplements use excipients and solvents that are not approved, meaning the product could not make a 100-percent organic claim. In some cases, the capsule material itself may disqualify the claim. With more complex formulas or formats, its more difficult for supplement manufacturers to create a product that complies with the organic labeling requirements," Wilson said.
Industry leaders may want to lobby for adding key excipients and materials utilized in supplement manufacturing, Wilson suggested. Having those materials recognized on the National List would certainly expand their opportunities," she said, noting some companies have already approached AHPA regarding the matter.
And as with all manufacturing processes, Bowen reminded supplement firms to keep a well-documented paper trail.
When it comes to organic formulation, the most important thing is making sure you have very thorough documentation," she said. When the on-site audit takes place, you should have the documentation to show that you have the necessary trainings, standard operating procedures (SOPs) and proof in place that the ingredients you utilize meet the requirements of the NOP."
Moving forward, both organizations hope the whitepaper can educate supplement companies of all sizes on key issues in organic certificationand convince the companies still on the fence.
Manufacturers cant deny the demand for transparency that consumers are asking for," Bowen said. And now, they cant claim ignorance when preparing to enter the organic marketplace.
Options in Organic Labeling
The NOP identifies four distinct labeling categories for finished products, ranging from "100 percent organic" to "some organic ingredients." Below, QAI and AHPA break down the differences between the organic labeling options.
"100 percent organic": These products must contain 100-percent organic ingredients and processing aids. This label typically is used for single-ingredient items or simply processed goods, and it can display the USDA organic seal or the words "100 percent organic" anywhere on the label. The company must identify the USDA-accredited certification organization on the information panel.
"organic": Products with an "organic" label contain at least 95-percent organic ingredients. Non-organic ingredients and processing aids used must be included in the National List (205.605 and/or 205.606). The additional ingredients cannot be produced with genetically modified organisms (GMOs), irradiation or sewage sludge. The manufacturer is required to list the certifying body and identify ingredients as "organic" in the ingredient statement.
"made with organic [specific ingredient]": The third-tier of the organic labeling includes products containing at least 70-percent organic ingredients, with the same requirements for additional ingredients listed above. These products cannot use the USDA organic seal, but must identify the certifying body.
"some organic ingredients": Processed products can display this claim if they contain less than 70-percent organic ingredients. These goods cannot use the USDA organic seal or the certifying organization logo; however, they can list "organic" before appropriate items in the ingredient statement.
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