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 In July the agency issued a draft Guidance document which sets forth its current thinking concerning provisions of the law that dictate what ingredients can be included in dietary supplement products,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The FDA’s draft Guidance ignores the intent of Congress by seeking to impose insurmountable obstacles to the introduction of new dietary ingredients and includes interpretations that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: