The American Herbal Products Association has released a guidance for industry to help supplement manufacturers better understand how to comply with organic labeling requirements.
The guidance, produced in conjunction with Quality Assurance International, an organic certifying agency, gives an overview of the various categories of organic labeling and what manufacturers would need to know in order to fit their products into them.
The guidance will be of particular help to smaller or newer companies, said AHPA president Michael McGuffin. Some of the bigger or more established companies are already well aware of these requirements, he said. But questions the organization was getting from industry led him to conclude that we was a need for companies that might not have that expertise on staff.
“I think the companies that are well established know the rules very well. (But) we had some small business members approach us to say they were interested in organics and it was obvious they didn’t know the rules very well,” McGuffin told NutraIngredients-USA.
Door opened in 2005
Supplements were originally outside of the scope of the National Organic Program when its rules were made final in 2000. But in 2005, the program ruled that an ingredient that comes from a compliant agricultural process could be labeled as organic regardless of end use (i.e. whether that ingredient is used in a conventional food or a dietary supplement), which opened the door for supplement manufacturers who wanted to access this still small but growing end of the supplement market.
The guidance goes into detail on the four labeling categories, which are: “100 organic,” “organic,” “made with organic (specific ingredients)” and “some organic ingredients.” Each has a precise definition of what that label claim means for product contents. The first is fairly self explanatory, except that it extends to the processing aids of ingredients, which must be organic, too. The second category allows the inclusion of up to 5% of nonorganic trace ingredients that must come from a NOP-approved list.
The step down to the third category introduces the 70% level, the one that is probably most applicable to supplements, McGuffin said. At least 70% of the contents must be organic for this label claim, and a company could call out specific organic constituents in the ingredient list. The non-organic ingredients or processing aids must come from the NOP’s National List, and therein lies the rub for supplement manufacturers. McGuffin said meeting these varying labeling requirements could be fairly straightforward for the makers of teas and tinctures, but it’s a lot more complicated for capsule and tablet delivery forms, where the delivery vehicle itself already makes up 20% or more of the product’s total weight.
“I think that 70% tier is approachable in some products. Companies are going to have to address that even in the formulation stage if they want to sell an organic product,” McGuffin said.
A question of excipients
Organic labeling presents a similar conundrum to a supplement manufacturer as the labeling of genetically modified ingredients might, namely, the status of excipients. Some forms of cellulose typically used in supplements—microcrystalline cellulose and methylcellulose, for example—are not permitted because they do not appear on the list. The food industry worked assiduously to make sure its preferred nonorganic excipients and processing aids were considered for inclusion on the National List. By comparison, the supplement industry was slow on the uptake, McGuffin said.
“We’ve got some catching up to do. We have now started to talk among ourselves (about submitted ingredients to the list),” McGuffin said.
“At this point is a pretty well established process that is very information intensive. It can be a tedious process. That’s what we will be studying and determining what the costs and resources are and whether we can make the required arguments,” he said.
“It has more to do with that (the proposed ingredient) doesn’t disrupt the organic value of a product. You shouldn’t be able to put a toxic chemical in a product and still sell it as organic,” McGuffin said.