Called Opadry NutraPure, the USDA certified organic coating system was first unveiled by Colorcon Inc. at the Supply Side West trade show in Las Vegas in November. The coating was developed in a response from the market for more ingredients that could be called ‘natural,’ said Ali Rajabi-Siahboomi, vice president and chief scientific officer for Coloracon, which primarily serves the pharmaceutical industry and has facilities worldwide.
A big issue with responding to that call was the definition of ‘natural’ is so slippery, Rajabi-Siahboomi told NutraIngredients-USA.
“We were getting more requests for things that were ‘natural.’ There is no proper definition of what is natural. We took that on board and said, we could have our own internal definition of what natural means, but what would that mean for the market? One way we could show that the product is natural is to go through the certification process for organic,” he said.
The new coating system is made entirely from plant ingredients and does not rely on harsh processing of those feedstocks. Existing cellulosic coating systems are plant-based, too, Rajabi-Siahboomi said, but are produced with a variety of chemical processing steps.
Making supplements organic
Certifying dietary supplements as organic is tricky because, unlike most food products, the ancillary components, excipients like carriers and stabilizers and the capsules or coating systems, can make up such a large part of the whole. The active ingredient might be measured in milligrams within a whole that might weight several grams or more.
The American Herbal Products Association released a guidance in September of last year to help dietary supplement companies who were seeking to launch organic products.
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,” said Michael McGuffin, executive director of AHPA.
Coatings are small part of whole
As far as meeting these benchmarks is concerned, Rajabi-Siahboomi acknowledged that coatings are a small part of the equation.
“In terms of the percentage of the amount of nonorganic ingredients allowed in a product, I don’t think it plays a major part. We recommend using Opadry NutraPure at a level of one percent weight gain,” he said.
But he said there is still a big call for a natural system, even if it is not a big part of the overall organic certification picture.
“If you look a the products in the market, some of them are not coated at all. Some of these products have problems with friability, with dusting and with fusing, with taste and swallowability. Opadry NutraPure enhances the appearance of the tablets. It produces a high gloss tablet which consumers will find appealing and easier to swallow. It also imparts exceptional flow to coated tablets and eliminates dusting which facilitates packaging and handling, easing manufacturing,” Rajabi-Siahboomi said.
“We are very excited about this system. We know that the nutritional market is growing rapidly and there is a desire for more natural, organic material to go into the dietary supplement market,” he said.
Colorcon achieved its organic certification on the product in conjunction with Quality Assurance International, the same organization AHPA partnered with in the development of its monograph. Along with a demand for organic products, consumers are also increasingly seeking non-GMO certified products. While a certified organic product necessarily means it contains no GMO ingredients, not all consumers make the connection. The new coating system does not have non GMO certification as of the moment, though Rajabi-Siahboomi said that is under consideration for the future.