1. William Shakespeare, Sonnet LXVI.
2. The FDA is an agency within the US Department of Health and Human Services.
3. 21 U.S.C. section 301 et seq.
4. 15 U.S.C. 1451 et seq.
5. This is a distinctive feature of the legal system in the United States. Under other systems a product is regulated usually as either a cosmetic or a drug, although most regulators do acknowledge the existence of “borderline” products, that is, products that do not belong to a single category.