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Food and Drug Law
Seton Hall Unversity School of Law
Paradise, Jordan


Class 1 Slides

· FDA Mission Statement

o Protect public health

§ Assure safety, efficacy, security

o Advance public health by helping speed innovations

§ Made medicines & foods more

· Effective, safe and affordable

o Help public get accurate science-based information

· FDA Duties

o 1. Product review & approval / clearance

o 2. Rulemaking

o 3. Standard setting

o 4. Public education & communication

o 5. Enforcement

· FDA is super important because it regulates 25% of the dollars of consumer spending & regulates 1/3 of all imports

o Food, drugs, cosmetics, vitamins

· Political and policy debates that the FDA finds itself in

o Life style & personal choice issues

§ Tobacco, obesity

o 1st amendment rights

§ Promotion restrictions

o Abortion rights

§ Plan B, Ella

o Right to treatment

§ Access to unapproved products

o Health care costs

§ Drug importation, generics

o Economic fraud

§ Quack cures, inaccurate claims

o Safety

§ Avandia

o Product liability

§ Vioxx

· FDA Organization

o Part of DHHS (FDA Commissioner serves under DHHS Secretary)

o Commissioner appointed by President w/ advice and consent of Senate

o 6 centers: CDER, CDRH, CBER, CFSAN, CTP, CVM

o 5 regional field offices (pacific, SW, central, SE, NE)

· Legal Hierarchy

o Constitution >

§ Commerce clause & 1st amendment

o Statutes >

§ FDCA, etc.

§ 21 U.S.C. 301 et. seq.

o Regulations >

§ Notice and comment rulemaking

o Guidance Docs >

o Informal statements & advice

§ Warning letters and opinion letters

· FD&C Act

o 1906 Pure Food & Drugs Act

§ Mfr, labeling requirements for food & drugs

§ No S&E requirements

§ Mfrs must knowingly fraudulently represent products on market to violate

o 1938 FDCA

§ Expanded federal authority to regulate therapeutic devices and cosmetics along with drugs

§ Provisions for drug approval on basis of safety, IND approval process, factory inspections, remedy of ct injunctions and seizures

§ Regulation of devices still limited to adulteration and misbranding provisions

o 1962 Kefauver-Harris Amendments

§ Efficacy requirement added for drugs: S&E required

§ AER’s GMP’s & risk/benefit disclosure b4 ads

§ Devices still subject only to adulteration and misbranding

o Post 1962 K-H A’s

§ Ad hoc actions in approval process

§ Courts upheld FDA actions in mandating safety data and approval for particular medical devices that they classified as new drugs in order to require S&E

· U.S. v. Bacto-Unidisk

· AMP, Inc. v. Gardner

o 1976 Medical Device Amendments

§ Tiered regulatory system for medical devices

· 1. Inventory and classification of marketed devices for regulatory purposes

· 2. 3 levels of oversight

· 3. Regulation of “substantially equivalent” devices via PMN (510k process)

· 4. Drug-like clinical trial and approval process for high risk devices (PMA process)

o 2007 FDAAA (food and drug administration amendments act)

Class 2 Slides

· Chevron: FDA interpretations have been given much deference by the courts particularly involving technical or scientific matters

· FDCA § 701(a) authorizes rulemaking

o Rulemaking = adoption or regulations to carry out statute

§ Process:

· Notice of proposed rulemaking in Fed. Reg.

· Public comment period (60 days)

· Final rule published in Fed. Reg.; codified in CFR

· Final Agency Rule

o Sets forth substantive and binding requirements and may be challenged in court as final agency action on a topic

· Citizen Petition

o Submitted to FDA by anyone under established regulations in CFR to challenge Final Rule

o FDA has 180 days to respond

§ If it doesn’t à petitioner can sue (standing created)

· Judicial Review under APA (administrative procedure act) is that agency action is unlawful if:

o Contrary to law; arbitrary and capricious; abuse of discretion; unreasonable withheld

· What does a Federal Register notice do?

o Policy announcements; interpretive rules; notice of public hearing; call for data

· What do Advisory Opinions do?

o Set forth matters of general applicability, not product specific

o Don’t go thru notice and comment rule-making

o Bind agency; if the FDA changes its mind it must state so and issue revised Advisory Opinion

o Compliance Policy Guide Manual is another type of advisory opinion

§ Binding

§ Advice to inspection and compliance staff in the field regarding FDA’s standards and procedures

§ Lays out how the standards should be applied to determine regulatory compliance by industry members

§ FDA can be challenged on enforcement of this

· What are Good Guidance Practices?

o They set forth FDA’s current view of a regulatory issue (addressing scientific questions a lot)

o Not legally binding however on the FDA or industry

o Not considered a final agency action that is challengeable in court

· What are Staff Manuals & Guides?

o For FDA employees explaining their r

form unless bears label containing

· (1) name and place of business of the MFR / packer / distributor; &

· (2) accurate statement of quantity, (reasonable variations permitted) & exemptions for certain small packages

§ (g) if it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations under § 341 unless

· (1) conforms to definition and standard; &

· (2) label bears name of food specified in definition & standard, & if required by regulations, common names of optimal ingredients present in the food

§ (i) unless label bears

· (1) common or usual name of food; &

· (2) common or usual name of each ingredient

§ (q) misbranded unless label/labeling has nutrition information

· (a) serving size / common household unit measure

· (b) # of servings

· (c) # of calories

· (d) fat, sat. fat, chol., sodium, carbs, complex carbs, sugar, fiber, protein

· (e) vitamins and minerals

o Food Label to contain:

§ Identity statement

§ Net quality of contents statement

§ Responsibility statement

§ Ingredient statement

§ Flavor labeling

§ Nutrition facts

§ Nutrient content claims

§ If import; country of origin

Class 4 Slides

· Standard of Identity:

o “recipe” for foods to protect consumers from deception 21 U.S.C. § 343(g)

§ “enriched farina” v. “farina” Federal Security Administrator v. Quaker Oats

§ “cream cheese” v. “Neufchatel” Columbia Cheese v. McNutt


o Inferior product that tastes, smells like product

o 21 CFR 101.3(e): nutritionally inferior to food for which it is a substitute

§ For protein or essential nutrient ≠ fat, calories

· Nutrition Labels

o 1990 Nutrition Labeling and Education Act (NLEA) added 21 U.S.C. § 343(q) to require uniform nutrition labeling for most food products

o (a) & (b) Serving size & number of servings

o (c) calaories

o (d) fat, sat. fat, chol., sodium, carbs, complex carbs, sugar, fiber, protein

o (e) vitamins and minerals