Color Additives Amendment, New Drug Act and Cosmetic Regulation
Color Additives Amendment 1960
Colorant means a dye, pigment or other substance that is used to impart color or
or alter the color of a food-contact material, but that does not migr
Tamper-Evident Packaging Regulations
Product placed randomly on shelves at 6 locations, mostly drug and grocery
Cyanide was 90% pure, probably the type u
Hazardous Materials Packaging
1866 - Sen. Chandler
Coast Guard -
Federal Aviation Administration -
Interstate Commerce Commission -
Dec. 1990 -
Title 49 CFR part 100-199
A good place to go for help:
Occupational Safety & Health Administration (OSHA) Regulations
Established with Occupational Safety and Health Act of 1970.
In 1974 -
Nov. 23 1983 - OSHA issued
Extends to all places of work
Ex. - Clemson compliance.
Alcoholic Beverage Laws
Label requirements for Wine:
States can also have their own requirements.
How many of you have noticed the warning that is printed on the plastic bags?
Where do you think spec
1938 FOOD, DRUG & COSMETIC ACT AND
THE 1958 FOOD ADDITIVES AMENDMENT
The 1938 Food, Drug & Cosmetic Act
(A) General Regulations
(B) Food and Drug Products
(C) Animal Drugs
(D) Human Drugs
Food Additives Amendment 1958 (Continued)
Role of Extraction Studies
Developed as result of Ramsey proposal and Monsanto precedent
FDA specifies food simulating solutions to be used in testing:
Disagreement between EU and US FDA rega
Trade Dress and Patents
or may use Registered in U.S. Patent and Trademark Office or Reg. U.S. Pat. &
Tm Off. to indicate registration.
Four basic elements:
Your competitors trade dress is so substantially
Early Packaging Laws
The Pure Food and Drug Law of 1906-enforcement: the Bureau of Chemistry
The Meat Inspection Act of 1906-enforcement: USDA
The Sherely Amendment (1912) to the
In 1914 the Federal Trade Commission was given r
PKGSC 368 Review Questions for Midterm Exam
1. What are ethics? What do they represent?
2. If you are interested in protecting and advancing human rights globally, what will you
3. What is antitrust?
4. Legal ethics with respect to gi
Please write a thorough, detailed, and specific response for each of the following items.
Research beyond the lecture notes is required, advised, and will help adequately address
each issue. You must use at least two
PKGSC 368 - PACKAGING & SOCIETY
Early Packaging Laws
The laws and regulations are designed to
Three ways to classify laws
Federal vs. State and Local Laws
State and local laws in the health area will p