What type of safety concerns should be factored into FDA decision making?
Safety is an issue only if the product is not lawfully saleable as a dietary supplement under the Food Drug and Cosmetic Act (due to adulteration). If a petitioner were to seek agency health claim approval for a dietary supplement that contained ingredients that were adulterated, then the FDA would fulfill its statutory duty without offense to the First Amendment by denying the petition. That is because the denial would be based on the unlawful status of the product, a statutory determination that can be rendered without regard to the content of what is communicated. If, however, the dietary supplement contained ingredients lawfully saleable but known to cause adverse effects in a subset of the American population or to cause adverse effects at some level of ingestion, then the FDA would act properly by requiring an appropriate disclaimer but improperly by denying the petition. That is because use of a disclaimer in such a circumstance is an obvious, less speech restrictive alternative
