The FDA New Dietary Ingredients Guidance

The Food and Drug Administration (FDA) has recently commenced a new assault against the dietary supplement industry – one that could threaten the availability of supplements currently on the market and that will discourage manufacturers from innovating new and more beneficial products in the future. In July the agency issued a draft Guidance document which sets forth its current thinking concerning provisions of the law that dictate what ingredients can be included in dietary supplement products, and what information companies must submit to the FDA if they desire to market a supplement that contains a new dietary ingredient (i.e., one that was not sold prior to October 15, 1994). The FDA’s draft Guidance ignores the intent of Congress by seeking to impose insurmountable obstacles to the introduction of new dietary ingredients and includes interpretations that will threaten the continued sale of supplements if even the most minute of changes are made. If the Guideline is finalized and enforced by the FDA it will go a long way towards establishing the agency’s long-standing goal of requiring pre-market approval for dietary supplements. The following are a few highlights of the Guidance document:

  • The FDA’s draft Guidance requires companies to possess exorbitant amounts of information concerning their existing dietary supplements to prove that New Dietary Ingredient (NDI) notifications are not required for the products they are currently marketing. In many cases, it will be impossible to gather such information, thereby threatening the future availability of numerous dietary supplement products on the market today.
  • In order to market a product that contains a new dietary ingredient, manufacturers will be required to submit a tremendous amount of information concerning historical use of the ingredient or conduct a multitude of animal and human studies which are overly burdensome and costly. Establishing such excessive requirements is both contrary to Congressional intent and unnecessary given the safety record of dietary supplements over the past few decades.
  • Any change in the manufacturing process of a dietary ingredient that results in chemical alteration of such ingredient or a change in specifications of the ingredient, regardless of how insignificant the alteration or change is, will require the submission of a NDI notification. This will discourage manufacturers from using the most advanced and efficient manufacturing technologies and pursuing methods that can improve the safety and effectiveness of dietary supplement products.
  • Any increase in the amount of a dietary ingredient in a dietary supplement or any change in the formula of a dietary supplement, regardless of how minute or insignificant, will require the submission of a NDI notification. This will discourage the innovation of new products.

FDA’s enforcement of its Guidance as currently drafted could have a devastating impact on the dietary supplement industry and significantly affect the availability of supplement products on the market today and in the future. We urge you to contact your representatives in Congress and express your concerns. While personal letters are always best, attached for your convenience is a form letter. Don’t just sit back while the FDA threatens your right to access cost-effective and beneficial dietary supplement products. The industry needs your help in fighting back against this bureaucratic power-grab. To find government contact information including mailing addresses for your Senators and US Congressional Representative, please visit www.usa.gov/Contact/Elected.shtml These letters are samples, please feel free to personalize them. Biotics Research will continue to post updates on activity related to FDA’s NDI guidance.

Yours in health,
Denis DeLuca
President of Biotics Research Corporation

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