Ch. 6 (FOOD & DRUG ADMINISTRATION)

Food Regulation by FDA

-Originally only had control over canned goods --FDA established standards --Quality --Fill of the container -Stated adding nutrients to products -Leads to controls

Enforcement by the FDA

-Recalls: product removed from mkt -Injunction issued -Seizure of the subject product -Fines -Consent Decree -Criminal Investigation

Events lead to Major Change

-Spanish-American War -Publication of The Jungle by Upton Sinclair Change was the Pure Food and Drug Act (1906)

Structure of the FDA

-Under the Dept. of Health & Human Services -Organization: ---Office of Commissioner ---4 subparts: (medical products and tobacco, foods, global regulatory operations, operations) -FDA Regulates many things, not just food and drugs

Food, Drug and Cosmetic Act of 1938

-Manufacturer's had to prove that drug was safe before it could be used and required FDA approval -Required doctor's prescription of drugs, prescription v. over the counter drugs -Greatly expanded the power of the FDA -Extended power of FDA to ---Cosmetics ---Therapeutic Devices -Gave new enforcement powers -Meat still exempt under the USDA

Reporting Violations to the FDA

CAN BE DONE BY: -Individuals/Consumers -Health Professionals -Industry Members themselves PROCESS -File complaint -FDA investigates and then creates a report REPORT RESULTS -No Action (no violation of comp. found) -Objectionable conditions found (voluntary changes usually made by comp.) -Serious Objectionable Conditions (Most serious) Warning Letter sent with FDA's positions/reasons Warning of enforcement to come

Food Additives

any ingredient added to a food that was not naturally occurring in food -prevents any additives known to be cancer causing --manufacturers have burden of proof to show that additive is not carcinogenic

FDA

-Administrative Agency for the Federal Government -Started as Bureau of Chemistry...which became the Food, Drug and Insecticide Administration before... being called the FDA -Now, under the Department of Health, Education and Welfare (HEW)

Kefauver-Harris Amendments 1962

-Another tragedy: Thalidomide (Europe not US) -Led to Kefauver-Harris (greater control by FDA) -Drug had to be ruled safe by FDA to be sold -Also had to be effective (maximum response achievable) -Also gave FDA control over drug advertising

Delaney Clause in 1958

-FDA assumed control over food additives -Banned carcinogenic, (cancer causing) additives -Zero risk standard meant ANY showing of cancer meant the additive could NOT be used (will be changed)

Areas of FDA Regulation

-Foods -Dietary Supplements -Human Drugs -Vaccines, blood products and other biologics -Medical devices including electronic products -Cosmetics -Veterinary Products -Tobacco Products -Shares in regulation of several other products such as ---Pesticides ---Drinking Water

Change was the Pure Food and Drug Act/Wiley Act (1906)

-Forbids interstate and foreign commerce in adulterated and misbranded, making false or misleading label claims, in food & drugs -Drugs had to abide by standards of purity and quality -Any variations from standards had to be disclosed on the label