In a letter dated January 10, 2017 to President-Elect Donald Trump, Dr Dan Fabricant, NPA’s CEO and executive director, outlines the importance of the natural products industry to the economy and to the health of the nation. Dr Fabricant then takes aim at several issues, including the recently re-released draft guidance for New Dietary Ingredients.
“One area of significant regulatory burden that we hope to work with your administration on is the Food and Drug Administration’s (FDA) draft guidance for New Dietary Ingredients (NDI),” states Dr Fabricant.
“The NDI draft guidance is one of the areas the industry has been working with the FDA to improve and was prepared in advance to address. This is important, because the current draft guidance could actually result in more bad actors skirting the law entirely, which is the opposite of what a sensible regulatory regime should be. The FDA must also consider the economic burden on small businesses that could create a chilling effect on innovation, and lead to fewer submissions from legitimate firms.
“We want to see the agency get the guidance right and meet with the industry, not rush to finalize which would only serve to enable plaintiff attorneys to use the current version and its inaccuracies as a binding norm to tax a growth industry.”
NPA has consistently maintained that kratom (Mitragyna speciosa) poses a threat to public health, and may be contributing to the nation’s opiate abuse epidemic. President-elect Trump himself talked about the use of opioids on the campaign trial.
“NPA has taken the side of strong industry enforcement, advocating that finished kratom products and raw kratom botanical ingredients have not met the strict standards products and new ingredients must adhere to in order to be marketed to the public and deemed safe for regular use in either our food or our drug supply,” states Dr Fabricant.
Food insecurity and reducing healthcare costs
The letter also highlights the issue of food insecurity, pointing out that 19% of households with children are food insecure.
“[NPA] is advocating to expand access to nutritional supplements for the Special Supplemental Nutrition Program for Women, Infants, and Children, or WIC. This program provides 8 million American families the ability to purchase healthy and nutritious foods. With the help of our Members of Congress, we can provide low income women, infants, and children the equal access to vitamin and mineral supplements they deserve.”
Dietary supplements such as omega-3s and niacin could also help to reduce healthcare spending, wrote Dr Fabricant. “If formularies at medical centers that are subsidized by the government replaced 10 percent of pharmaceutical omega-3 or niacin with an omega-3 or niacin dietary supplement of equal quality, federal taxpayers would save tens of millions of dollars a year.”
Medical foods and health claims
The final two issues raised in the letter are medical foods, with the recent guidance from the FDA described by Dr Fabricant as, “a stark example of a disconnect between nutritional science and FDA’s approach”.
“[W]e look forward to working with your administration on developing a clear definition for medical foods. Our goal should be to establish a clear path to market, utilizing the current state of nutritional science to benefit the health of all Americans while potentially reducing overall healthcare expenditures.”
On health claims, Dr Fabricant stated that the process is in desperate need of review, and noted that only 22 qualified health claims are currently allowed by the FDA, compared to over 200 health claims being approved by EFSA in Europe since 2012.
Dr Fabricant told us that he thinks the incoming administration is very receptive to growth industries, which includes the natural products industry. "We're proposing ways to reduce healthcare costs and clean up regulatory process, both of which will interest this administration," he said.
"Our letter provides seven or eight different areas to make viable changes that will immediately benefit both the industry and consumers," added Mark LeDoux, CEO of Natural Alternatives International and NPA's President.