History of the FDA

1. History of the FDA

2. Objectives • Describe the need for the FDA • What is the Food Safety Modernization Act (FSMA)?

3. Early Laws • The Vaccine Act of 1813 • Bad Smallpox Vaccine • First Federal Law Dealing with Consumer Protection and Drugs • Short-lived • Biologics Act of 1902 • Passed after Deaths Due to Bad Diphtheria Antitoxin

4. Harvey Wiley • Chemist for the Agriculture Dept - 1867 • Gathered men that were concerned with chemical preservatives/ additives “poison squad” – they consumed varying amounts of questionable food additives to determine if they were safe

5. History • June 1906 President Roosevelt signed the Food and Drugs Act (Wiley Act) • Law prohibited ‘the addition of any ingredients that would substitute for the food, conceal damage, pose a health hazard, or constitute a filthy or decomposed substance’. • If manufacturer opted to list weight, must be accurate. • Label could not be false or misleading and the presence and amount of 11 dangerous ingredients, including alcohol, heroin, and cocaine had to be listed.

6. Laird’s Bloom of Youth – 1860s- contained dangerous amounts of lead

7. 1938 – Food, Drug, and cosmetic Act • Was inacted as a result of products that maimed or killed • Sulfanilamide ( toxic chemical found in antifreeze) – was used in a “wonder” drug that appealed to parents for their children – killed 100

8. Cosmetics and Drug Definition • Cosmetics are: • “Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering appearance” • Drugs are: • “Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and articles is defined as – intended to affect the structure and function of the body of man or other animals.

9. Banbar – worthless cure for Diabetes • Lash Lure – dye that blinded women

10. Cosmetics and Medical Devices • Regulated by the post office department and Federal Trade commision prior to 1938 • 10 Day Press on Nails – caused nails to split down to quick or break off - 1957 • Orgone accumulators to collect ethereal substance 1960s • Use of poisonous additives – lead, arsenic, mercury

11. The Crystaldyne Pain Reliever, 1996Similar to The Stimulator The Stimulator is essentially an electric gas barbecue grill igniter outfitted with finger grips. When pressed against the skin, the devices sparks and causes a small electric shock. Makers of the device claim it can relieve headaches, back pain, arthritis, stress, menstrual cramps, earaches, sinus, nosebleeds, flu and other ailments. Because of its medical claims, the Stimulator is considered a medical device. The manufacturers, however, have not complied with any FDA regulations that govern the marketing of medical devices. The companies have submitted no information to FDA showing that the device is either safe or effective...

12. FDA Regulates • Biologics – blood supply, licensing, research for product standards • Cosmetics – safety, labeling • Drugs – labeling, OTC and prescription, manufacturing • Foods – labeling, safety(except meat and poultry), bottled water • Medical Devices – (implants) • Radiation Emitting Electronic Products – microwave, X-ray machines, sunlamps • Veterinary products – food, drugs

13. Amendments to FDA • 1954 –pesticide residue • 1958 – food additives • 1958 – Delaney Clause – banned any carcingoenic additive • 1960 – color additives • 1973 – regulations for vitamins and minerals/ fortified foods

14. Tatoo Inks and permanent Makeup • Inks are considered cosmetics. Pigments in inks considered color additives. • No color additives are approved for use in tattoo inks or permanent make-up. ( All are illegal under the FD&C Act) • Changes in patterns of use: • About 24% of population has had tattoos. For 18-29 year olds – 36%. • New pigments have no research for safe use as inks – especially colored inks.

15. Recent Enforcement actions • Seizures – Tanning pills • Rio – “natural” hair color straightner- contains lead • Eyelash enhancers • Kohl, color additive violations, microbial contamination, drug claims – contains lead • Colored contacts

16. FSMA • Food Safety Modernization Act was signed into law by President Obama January 4, 2011. • - Shifts the focus of federal regulators from responding to contamination to preventing it.