The Food Safety Modernization Act (FSMA) was signed into law on January 4 of this year. For the past several months weâ€™ve been sharing our concern over one of the FSMAâ€™s mandates that eventually developed into the disastrousÂ NDI draft guidance. There are only a few days left to tell the FDA what you think about these new anti-supplement rulesâ€”FDAâ€™s public comment period ends this Friday, December 2.Â Please take action today, if you havenâ€™t done so already!
There is another rule mandated by the FSMA, which is currently being implemented, that we also want to highlight. ItÂ gives the FDA wider authority to detain food products, including supplements. Under the previous law, in order to administratively detain food, the FDA had to show â€ścredible evidenceâ€ť that a food presents â€śserious adverse health consequences or death to humans and animals.â€ť The new rule gives the FDA enhanced authority to detain any food or supplement they have â€śreason to believeâ€ť may be â€śadulteratedâ€ť or â€śmisbranded.â€ť
Using the vague terms â€śmisbrandedâ€ť and â€śadulteratedâ€ť as a standard to detain food is extremely problematic. It gives the FDA too much discretionary power against small food companies and dietary supplements and potentially allows the agency to detain food and supplements on even minor violations. Under the â€śadulteratedâ€ť or â€śmisbrandedâ€ť standard, a farmerâ€™s paperwork error could be treated just as harshly as a multinational corporation that knowingly sells tainted food.
As weâ€™ve reported previously, a food or supplement may be considered â€śadulteratedâ€ť under the Federal Food, Drug, and Cosmetic Act if some vaguely written FDA rule is deemed to have not been followed. â€śMisbrandedâ€ť can mean that the producer makes a completely true statement about the productÂ but without FDA permission. A cherry producer who cites peer-reviewed scientific research from prestigious universities on the health benefits of cherries would, in FDA-speak, have engaged in â€śfalseâ€ť and actionable â€śmisbrandingâ€ť which suddenly turns the cherries into drugs. Producers, of course, have the right to take cherries through the vastly expensive new drug approval process!
â€śAdministrative detentionâ€ť means that the FDA can now act without judicial oversight. It doesnâ€™t even have to be true, since the FDA merely needs â€śreason to believeâ€ť that the product is misbranded or adulterated. This makes it an extremely subjective process.Â By its own admission, the FDA estimates that up to 48% of food detained could prove not to have been adulterated.
The food or supplement can be held for up to twenty days, with a possible ten-day extension if FDA wishes to initiate legal action. Many food products are perishable in that amount of time, which would have a severe impact on business, especially small businesses that could not cope with the loss.
This new, broader FDA food detention authority opens the door for the FDA to abuse its power and hold any supplement they believe has not filed an NDI notification. If the proper notification paperwork has not been submitted and officially accepted by the FDA, the agency considers them â€śadulteratedâ€ť supplementsâ€”even though FDAâ€™s interpretation of what a New Dietary Ingredient actually is and what the NDI notification process is supposed to entail are clearlyÂ contrary to what Congress intended when they passed the law. It also flies in the face of common sense.
This makes it extremely important that the NDI guidance be revised. As it stands now, the rules ensure that most dietary supplements will be found in violation of the FDAâ€™s ludicrous interpretation of the NDI notification process.
This article is republished with permission from the Alliance for Natural Health USA, December Â 2, 2011.Â Go straight to the source.