It’s a question lawyers practicing in the products liability field–especially in the food and drug arena–often get asked by family and friends: What exactly does the U.S. Food and Drug Administration (“FDA”) approve (and not approve)? The answer is usually a bit complicated and long-winded. But now, the FDA has given all consumers a handy guide that explains how the FDA regulates products — and what the agency does (and does not) approve. In this post, I will distill the FDA’s guidance to its essentials in the form of a handy check list.
First, what does the FDA regulate?
Human drugs and biologics
Food (including animal food)
Electronic products that emit radiation
Note, however, that FDA regulation in these areas does not necessarily mean that the product undergoes a premarket approval (i.e., agency review for “safety and effectiveness”), as described below.
What does the FDA approve?
New drugs and biologics. These must be proven “safe and effective,” that is, “the benefits of the product outweigh the known risks for the intended use.”
Medical devices, depending on the risk of the device. Class III (highest-risk) devices, such as mechanical heart valves, generally require FDA approval. Class II (moderate risk) devices, such as dialysis equipment and catheters, must be “cleared” by the FDA for marketing–which requires a showing that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval. Class I (low risk) devices, such as elastic bandages, tongue depressors, and examination gloves, are typically exempt from premarket notification requirements.
Human cells and tissues intended for use in humans, depending on risk. For example, bone, skin, corneas, ligaments, and tendons, are regulated to prevent the transmission of infectious diseases. If they pose an additional risk, they must be FDA approved before marketing.
Certain food ingredients, such as color additives. The manufacturer must demonstrate that a new food additive is safe. Additives include “food contact substances” such as the plastic, paper, or adhesive in the food’s packaging, since these substances make contact with the food itself. The review process for these “contact substances” is specific to the identified manufacturer or supplier. A notable exception to premarket approval of food additives is for “GRAS” ingredients, i.e., those “generally recognized as safe.”
Color additives used in FDA-regulated products, including food, dietary supplements, drugs, cosmetics, and some medical devices.
Animal drugs and food additives used in animal food. This includes pets, livestock, and poultry.
What does FDA not approve?
Companies, including health care facilities, laboratories, or manufacturers (though they must register with the FDA and are subject to FDA inspection).
Compounded drugs (where a pharmacist combines ingredients to create medications for individual patients).
Tobacco products. The FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population as a whole. Manufacturers of new tobacco products must receive a written order from the FDA before they may sell the product; the order does not state that the tobacco product is “safe” or “approved” but, rather, the manufacturer has complied with the requirements to sell the product.
Cosmetics, including perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers.
Medical foods (which are used for dietary management of a disease or health condition, such as phenylketonuria), as these are intended for use under the supervision of a physician. “Medical foods” does not include meal replacements or diet shakes, or products for the management of diseases like diabetes.
Infant formula, though manufacturers must register with the FDA, comply with federal nutrient requirements, and notify FDA before marketing a new formula.
Dietary supplements, though manufacturers must notify the FDA before marketing the product in some cases (e.g., it contains a new dietary ingredient that was not marketed in the United States before October 15, 1994).
Food labels (including the “Nutrition Facts” panel). While certain nutrition information must be included on the Nutrition Facts panel, the FDA does not approve food labels before the products are marketed.
“Structure-function” claims on dietary supplements and other foods. The FDA provides, as an example, “calcium builds strong bones.” The FDA does not “approve” such claims; supplement manufacturers, however, must notify the FDA of the claims and the label must include a disclaimer stating that the FDA has not reviewed the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.