How Much Do You Know About Fda

The Food and Drug Administration regulates a large number of consumer products–but not everything! How good are you at distinguishing which products FDA regulates from those it doesn’t? Take this quiz–put together by Bernie Janiger of FDA’s New York district office–and see.

Circle the one item in each of the following groups that is not under the jurisdiction of the Food and Drug Administration. Answers follow.

Question l:
a. Spam
b. puppy food
c. chocolate-covered cherries
d. frozen spinach
e. imported caviar

Question 2:
a. aspirin
b. anti-lice shampoo
c. insect repellent
d. eye shadow
e. lipstick

Question 3:
a. pesticide residues in lettuce
b. canned tomatoes
c. oven cleaner
d. spaghetti
e. pet turtles

Question 4:
a. airport security x-ray machines
b. laser products used in lumber mills
c. magnetic resonance imaging (MRI) diagnostic equipment
d. smoke detectors
e. microwave ovens

Question 5:
a. TV sets
b. over-the-counter antacid
c. TV ads for aspirin
d. diphtheria, pertussis and tetanus vaccine
e. human plasma

Question 6:
a. baby pacifiers
b. baby bottle nipples
c. ceramic ware for food use
d. coffee mugs
e. eye chart

Question 7:
a. illegal heroin use
b. veterinary tetracycline
c. barbiturates
d. medicinal oxygen
e. methadone

Question 8:
a. kidney dialysis machine
b. tongue depressor
c. toothpaste
d. fluoridated toothpaste
e. hair dryer

Question 9:
. a. label on beer
b. ground coffee
c. coffee beans
d. rabbit meat
e. canned tuna

Question 10:
a. home canning equipment
b. food warehouse
c. drug warehouse
d. hearing aid dispenser (retailer)
e. exporting of drugs

Question 11:
a. Halloween make-up
b. theatrical make-up
c. soap
d. eye mascara
e. nail polish

Question 12:
a. vaccine for horses
b. penicillin for horses
c. medicated feed for hogs
d. pet parrots
e. bird feed

Question 13:
a. tap water
b. club soda
c. bottled mineral water
d. ginger ale
e. bottled water for water cooler

Question 14:
a. tamper-resistant packaging for over-the-counter (OTC) drugs
b. child-proof packaging for OTC drugs
c. plastic containers for soft drinks
d. valentine heart containing chocolates
e. a tube containing medical ointment

Question 15:
a. grooming cream for dogs
b. artificial limb for dogs
c. laser scanner at supermarket checkout
d. mercury vapor lamps
e. vitamin C tablets

Quiz Answers and Explanations
1. Answer a: Spam is a meat product. The U.S. Department of Agriculture is responsible for regulating meat (and poultry) products.

Caviar, and all seafood and seafood products, whether imported or domestically produced, are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as a food. So, too, are the other choices.

2. Answer c: Insect repellents are regulated as pesticides by the Environmental Protection Agency.

Both aspirin and shampoos that get rid of lice are drugs; eye shadow and lipstick are cosmetics; all are regulated by FDA.

3. Answer c: Oven cleaners are regulated by the Consumer Product Safety Commission.

Canned tomatoes and spaghetti are regulated as foods by FDA. Tolerances for pesticide residues in foods are established by EPA, but FDA is responsible for ensuring that these tolerances are not exceeded on foods (except for meat, poultry and certain egg products, which are under USDA’s jurisdiction). A tolerance level is the maximum amount of a pesticide residue permitted in or on a food. FDA enforces a ban on the sale and distribution of turtles less than 4 inches long, the size most often sold as pets. Pet turtles frequently carry Salmonella bacteria, which may cause severe diarrhea in children and adults. Baby turtles were sold as pets in the United States until 1975, when the national Centers for Disease Control and Prevention determined that the bacterial contamination could not be prevented by any known treatment.

4. Answer d: Smoke detectors–both photoelectric and ionization chamber types–are regulated by the Consumer Product Safety Commission. The radioactive source used in the ionization chamber detector is naturally occurring, not electronic and, therefore, is not a substance that would be regulated by FDA. (The level of radiation exposure to home occupants from ionization chamber detectors is much less than that received from the low level of natural background radiation.)

Under the FD&C Act, FDA is responsible for protecting consumers from unnecessary exposure to radiation emitted from electronic products. (These provisions were originally separate from the FD&C Act and were referred to as the Radiation Control for Health and Safety Act. They were later incorporated into the FD&C Act when the Safe Medical Devices Act of 1990 was enacted). Airport security x-ray machines and microwave ovens must be properly shielded so that the radiation generated by these products (x-radiation and microwave radiation, respectively) does not harm anyone. MRI diagnostic equipment is regulated as a medical device under the FD&C Act. It is also subject to enforcement as an electronic product emitting radiation because it uses radio waves and a strong magnetic field to produce its images. Laser products used in lumber mills must conform to an FDA standard that ensures their safety. This standard applies to all laser products, whether medical, industrial or consumer.

5. Answer c: The only advertisements over which FDA has direct jurisdiction are those for prescription drugs. FTC oversees advertising for other FDA-regulated products.

TV sets are regulated under the radiological health provisions of the FD&C Act. All televisions must comply with a performance standard that ensures their safety. This standard also applies to video display terminals used with computers. Over-the-counter and prescription drugs, as well as human biological products (such as vaccines and blood products), are regulated by FDA.

6. Answer a: Baby pacifiers are regulated by CPSC unless they are marketed with health claims, in which case they are under FDA’s jurisdiction.

Food-contact articles, including baby bottle nipples, ceramic ware intended for food use, and coffee mugs, are regulated by FDA. So are eye charts, which, as diagnostic products, are considered to be medical devices.

7. Answer a: Illegal use of heroin is the responsibility of the Drug Enforcement Administration, the key federal agency that polices illicit, or “street,” drugs. (If heroin were being studied for medical uses, FDA would regulate it as an investigational drug.)

Barbiturates are subject to abuse and thus may, potentially, wind up on the “street,” bringing them under DEA’s purview. However, barbiturates have legitimate medical uses, and FDA is responsible for ensuring they are properly manufactured and labeled. FDA regulates methadone as a drug, and methadone maintenance treatment programs are monitored under regulations promulgated by both FDA and the National Institute on Drug Abuse (NIDA). Medicinal oxygen is regulated by FDA as a drug. Animal drugs, including veterinary tetracycline, are regulated by FDA.

8. Answer e: Hair dryers are regulated by CPSC.

Kidney dialysis machines and tongue depressors, as different as they are in complexity, are both considered to be medical devices. FDA regulates non-fluoridated toothpastes as cosmetics, and fluoridated toothpastes as drugs.

9. Answer a: Labels on beer and other malt beverages, distilled spirits (liquors), and wines are regulated by the Bureau of Alcohol, Tobacco, and Firearms under the Federal Alcohol Administration Act.

Ground coffee, coffee beans, rabbit meat, and canned tuna are all regulated by FDA as foods. (The Federal Meat Inspection Act, which gives USDA authority over meat products, covers cattle, sheep, swine, goats, and horses. Other meat products, including game meats such as rabbit, are regulated by FDA.)

10. Answer a: Home canning equipment, under a memorandum of understanding between FDA and CPSC, is regulated by CPSC.

FDA’s jurisdiction includes the facilities where the products it regulates are stored, such as food and drug warehouses. Hearing aid dispensing establishments are bound by specific FDA regulations that impose conditions for the sale of hearing aids. The regulations attempt to prevent misrepresentation and ensure adherence to proper medical standards. Regarding exporting drugs, FDA continues to have authority over its regulated products even when they are exported.

11. Answer c: The FD&C Act specifically excludes soap from its definition of cosmetics. CPSC regulates this product.

All of the other choices are defined as cosmetics and, therefore, are regulated by FDA.

12. Answer a: A vaccine for horses is a veterinary biological product. FDA does not have jurisdiction over veterinary biologics. The Virus, Serum, and Toxin Act gives this responsibility to USDA.

The FD&C Act gives FDA authority over pet foods and drugs, which would include veterinary penicillin, medicated feeds, and bird feed. The Public Health Service Act confers on FDA the authority to regulate the interstate movement of psittacine birds (parrots, cockatoos, macaws, parakeets, and other birds in the psittacine family). These birds are potential carriers of psittacosis, a disease that can be transmitted to people. Psittacosis, which is also known as parrot fever, can range in severity from a mild respiratory infection to a protracted illness.

13. Answer a: The safety of public drinking water (tap water) is protected by EPA, as decided in an agreement between that agency and FDA.

FDA has jurisdiction over bottled water, which is considered a food under the FD&C Act. The remaining choices are also defined as foods.

14. Answer b: Child-proof packaging authority, addressed under the Poison Prevention Packaging Act, was delegated to CPSC.

Tamper-resistant packaging, which is required for certain OTC drugs, cosmetics, and medical devices, is FDA’s responsibility. Food packaging materials, such as plastic containers and candy boxes, are subject to regulation as food additives under the FD&C Act because of the possibility that they may leach their chemical constituents into the food product. These potential additives are referred to as indirect food additives. A container bearing a drug product is considered to be a component of that drug, and FDA, therefore, requires that it be appropriate for that drug.

15. Answer a: The animal counterpart of a cosmetic is commonly referred to as a “grooming aid.” Cosmetics, as defined in the FD&C Act, apply only to human use. Therefore, products intended for cleansing or promoting attractiveness of animals are not subject to FDA control.

An artificial limb for dogs is regulated as a veterinary medical device. While such products do not require FDA approval, they do come under the purview of the FD&C Act. They may not bear labeling that is false or misleading, nor may they be otherwise misbranded or adulterated. The laser scanner must comply with the standard. Mercury vapor lamps, most often used to light streets, gymnasiums, sports arenas, banks, and stores, must be maintained properly to be safe. With some types of mercury vapor lamps, if the outer envelope is broken and the lamp continues to operate, intense, harmful ultraviolet radiation is emitted. An FDA standard ensures that this lighting is safe. Finally, FDA regulates vitamin C tablets as food supplements.