02.14.17
The Natural Products Association (NPA) admonished FDA’s “Dietary Fiber Guidance” on the scientific evidence needed and the approach to evaluating the scientific evidence for demonstrating a beneficial physiological effect of an isolated or synthetic non-digestible carbohydrates in humans.
“Another day, another regulation that ignores the negative economic impact on American consumers and small business,” stated Daniel Fabricant, PhD, CEO and executive director of NPA. “This guidance not only creates unreasonable regulatory barriers, but also forces the food and supplement industries to spend millions of dollars jumping through more regulatory hoops while the costs are ultimately passed onto consumers. We will work with Congress and the Trump Administration to use all of the tools at their disposal, including the Congressional Review Act, to correct this flawed guidance.”
“In the spirit of President Trump’s One-In, Two-Out regulatory scheme, the new Nutrition and Supplement Facts Label final rule defining dietary fiber last year should be moved out,” added Dr. Fabricant.
In their new definition of dietary fiber last year, FDA is linking the definition of dietary fiber with a new regulatory requirement for industry to demonstrate a beneficial physiological effect in accordance with the agency’s Significant Scientific Agreement in place for health claims on food ingredients, he said, adding that this amounts to the creation of a pre-approval process for isolated or synthetic non-digestible carbohydrates
“We have 27 years of experience declaring dietary fibers for non-digestible carbohydrates. It is another guidance and another regulation that does not speak to safety or quality for consumers. The beneficial effects of all non-digestible carbohydrates are embodied in their chemistry. They are not absorbed, water follows by osmosis, and they aid in alleviating constipation and reducing transit time in the digestive tract,” added Dr. Fabricant.
NPA’s comments can be viewed here.
“Another day, another regulation that ignores the negative economic impact on American consumers and small business,” stated Daniel Fabricant, PhD, CEO and executive director of NPA. “This guidance not only creates unreasonable regulatory barriers, but also forces the food and supplement industries to spend millions of dollars jumping through more regulatory hoops while the costs are ultimately passed onto consumers. We will work with Congress and the Trump Administration to use all of the tools at their disposal, including the Congressional Review Act, to correct this flawed guidance.”
“In the spirit of President Trump’s One-In, Two-Out regulatory scheme, the new Nutrition and Supplement Facts Label final rule defining dietary fiber last year should be moved out,” added Dr. Fabricant.
In their new definition of dietary fiber last year, FDA is linking the definition of dietary fiber with a new regulatory requirement for industry to demonstrate a beneficial physiological effect in accordance with the agency’s Significant Scientific Agreement in place for health claims on food ingredients, he said, adding that this amounts to the creation of a pre-approval process for isolated or synthetic non-digestible carbohydrates
“We have 27 years of experience declaring dietary fibers for non-digestible carbohydrates. It is another guidance and another regulation that does not speak to safety or quality for consumers. The beneficial effects of all non-digestible carbohydrates are embodied in their chemistry. They are not absorbed, water follows by osmosis, and they aid in alleviating constipation and reducing transit time in the digestive tract,” added Dr. Fabricant.
NPA’s comments can be viewed here.
