Dietary supplements should meet USP standards to cite outside structure/function data.

OUTSIDE DATA ON NON-USP SUBSTANCE INAPPROPRIATE FOR CLAIM SUBSTANTIATION, Utah Natural Products Director Loren Israelsen told a March 1 session of the National Nutritional Foods Association's symposium on structure/function claims. It may not be "applicable or in some cases even lawful to `borrow' science done on a non-compendial substance" to substantiate a structure/function claim, because the substance tested and the product for which the claim is made may differ, he cautioned.

"What's happening largely is that companies who own science are doing in-house review to design statements of nutritional support around their own science for their own products," Israelsen noted. However, "the second approach is reviewing external science to see what's out there," he said. "You say, `I have a product like that' and you import that science to design claims for your product."

If the product is "a vitamin, mineral or other substance where you have an external reference standard and you call up the vendor and say `I'd like USP this or USP that,'" Israelsen explained, "then it may be appropriate to go to the external literature and design your claims around non-in-house data." Because "the science was done on the compendial substance...in my judgment there's really no problem," he stated.

"However, with respect to custom or unique substances," Israelsen questioned, "is it appropriate to take that body of science for another extract which is not the same -- maybe close, but not the same?"

Citing remarks made by Federal Trade Commission Division of Advertising Practices Associate Director Lee Peeler earlier in the symposium, Israelsen warned: "If you send FTC a box full of [external] literature [on a non-compendial substance], they're very likely to tell you it's not relevant."

In weighing the appropriateness of using external data for claim substantiation, companies also must determine whether "the dosage match[es] what you're offering and the potency of your product," Israelsen advised. "If not," he warned, "there's a question as to whether the claim is substantiated." In addition, Good Manufacturing Practice considerations "are obviously very important," Israelsen stated. "Once you make a claimed benefit, your product has to sustain that benefit throughout its shelf-life," he noted.

Delivery systems need to be considered in matching science to products, Israelsen pointed out. "If the original data was done on a tablet and you put the form in a capsule or some other delivery system, how do we know that the body absorbs it the same way?" he asked. "How do we know the benefit is the same?"

Israelsen also posed the question: "What if you buy from different vendors and the material you buy from vendor A ends up being somewhat different than what you bought from vendor B? As you change vendors, what happens to your structure/function claim? Is it still valid?"

"Long-term, it's really not the Congress or the FDA or the FTC that I'm concerned about," Israelsen stressed, "it's the goodwill and confidence of the customers. If they ever lose confidence in the products, we have a far more serious problem than dealing with the FDA or the FTC."