Final answer:
FDA guidance documents are not legally binding but provide the FDA's current thinking and help companies comply with regulations. The FDA has authority to enforce numerous laws, including the power to regulate tobacco products following the Family Smoking Prevention and Tobacco Control Act.
Step-by-step explanation:
The FDA guidance documents are not legally binding or enforceable in the same way as laws or regulations. These documents provide the FDA's current thinking on a topic and are intended to assist companies in complying with federal regulations. While they do not have the force of law, adherence to guidance documents can demonstrate a company's commitment to compliance and may help avoid enforcement actions by indicating that the company is making an effort to meet regulatory expectations.
The FDA is empowered by Congress to enforce various laws, including the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. This includes regulations on a wide array of products ranging from drugs and cosmetics to cellular phones and tobacco products. After the enactment of the Family Smoking Prevention and Tobacco Control Act in 2009, the FDA was granted the authority to regulate tobacco products.