The Food Drug and Cosmetic Act of 1938
The Food Drug and Cosmetic Act of 1938 (FDCA) required medications be proven safe when used according to the directions on the label prior to marketing. It also required that labels include adequate directions for use. The Food Drug and Cosmetic Act of 1938 also requires habit-forming drugs to include a warning of the habit forming risk. Drugs already marketed prior to 1938 were exempt or “grandfathered” and did not require a change to their labeling or safety studies under this law. This was the first law that included cosmetics and medical devices into medication and food legislation. The FDCA also defined a dietary ingredient as “a vitamin, mineral, herb, or other botanical, amino acid, a dietary substance to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients”. The FDCA also established the Homeopathic Pharmacopoeia of the United States (HPUS) as an official compendium, requiring drug products using an official listed name to meet all of its standards (otherwise would be considered misbranded or adulterated). This Act became the groundwork for further amendments and subsequent laws regarding drug legislation in the United States. Other specifications in the FDCA include the medications below.
Ipecac Syrup
Reminder: Ipecac Fluid Extract is not the same as Ipecac Syrup. Ipecac Fluid Extract is 14 times as potent as Ipecac Syrup!
Must have a statement boxed and in red text that states “For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room immediately for advice.”
Must carry the statement “Warning: Keep out of reach of children. Do not use in unconcious persons or for poisoning involving corrosives (lye, strong acids), petroleum distillates such as kerosine, gasoline, cleaning fluids, or for strychnine”.
The usual dosage is 1 Tbsp or 15mL in patients over one year of age.
Ipecac syrup is only able to be sold in 1 oz or 30mL containers.
The FDCA also requires that certain drugs and adjuvants carry special warning labels. Examples are:
FD&C Yellow No. 5 (tartrazine)
Labeling must list in the precautions and specify that it may cause allergic reactions in some individuals
Aspartame
Labeling must carry a warning of “Phenylketonurics: Contains phenylalanine _x_ mg per _x_ (dosage unit)”
Sulfites
Labeling must contain an allergy warning in the labeling of prescription drugs and wines
Mineral Oil
Labeling must contain a warning that it should be used at bedtime, warn that it not be used in infants unless under the direction of a physician and should discourage use in pregnant women
Wintergreen oil (methyl salicylate) in amounts > 5%
Labeling should warn to keep out of the reach of children and also warn that using other than how directed may be dangerous
Sodium phosphate (saline laxative)
Packaging is limited to no more than 90mL per OTC container
Isoproterenol Inhalation Products
Labeling should warn not to exceed the dose prescribed and also warn to get medical assistance and/or contact physician if user continues to have breathing difficulty
Acetophenetidin (Phenacetin)
Labeling must carry a warning about possible kidney damage when taken in large amounts or for long periods of time
Salicylates (includes aspirin)
Labeling must include a warning about Reye’s Syndrome
Alcohol warning
Labeling for analgesics and antipyretics (acetaminophen, aspirin, ibuprofen, naproxen, etc.) are required to warn patients to consult with their physician before taking these medications if they consume ≥ 3 alcoholic beverages per day
