1) Introduction
a) 1906 – first Act adopted
b) 1938 – re-enacted FD&C Act
i) Notes –
(1) Increasingly complicated and detailed
(2) Renewed every 5 years
c) FDA’s Structure & Organization
i) Commissioner
(1) Appointed by the President w/ the advice and consent of the Senate. Political impact of this appointment process.
(2) Moderated by:
(a) High visibility of the agency
(b) Scientific decision making
(c) Lower level policy making
(d) Reports directly to the Secretary of Health and Human Services but often has a direct line to the White House/Prez.
(e) No longer has weekly staff meetings.
ii) Eight/Nine Offices:
(1)
PROHIBITED ACTS & PENALTIES
§ 301 – prohibited acts defined (derivations of introduction/delivery into interstate of adulterated/misbranded food, drug, device, or cosmetic)
§ 302 – injunction proceedings
§ 303 – penalties
§ 304 – seizure
Commissioner’s office and central administrative staff
(2) Field operations (5 regional, 24 district, 144 residential posts)
(3) National Center for Toxicological Research
(4) CDER (for Drug Evaluation and Research)
(5) CBER (for Biologics Evaluation and Research)
(6) CFSAN (for Food Safety and Applied Nutrition)
(7) CDRH (for Devices and Radiological Health)
(8) CVM (for Veterinary Medicine)
I. Foods: Deceptive Labeling
a. Background
i. Section 403 – every food must bear: name of food; statement of ingredients; net quantity of contents; name and address of manu.
ii. 403(j) – requires label information concerning the vitamin, mineral, and other dietary properties of food represented for special dietary uses. See S.411
iii. 403(a) – prohibits any false or misleading statement in food labeling.
1. Product composition info lawful, but specific claims that composition of food would help prevent particular disease unlawful.
b. Scope of labeling
i. 201(m) – labeling is “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.”
ii. 201(k) label – “a display of written, printed, or graphic matter upon the immediate container of any article…”
c. Labeling Requirements of Section 403
i. S.403 (misbranded food) contains two provisions: (1) prohibits certain types of representations and (2) requires disclosure of specified information
ii. United States v. Ninety-Five Barrels of . . . Apple Cider Vinegar (prohibited representations under 403(a)
1. Facts: FDA goes after Apple Cider Vinegar because the label on the bottle said it was “made from selected apples” and the words are misleading because the apples were from dehydrated apples and not from fresh apples. Apple cider comes from fresh apples. Apple cider vinegar is made from apple cider.
2. Rule: § 8 of the Food and Drugs Act, 34 Stat. 768 – prohibited every statement, design or device which could mislead or deceive
3. How do cts know what apple cider vinegar is? From what the general population would understand. There is a popular meaning of apple cider vinegar.
4. Company argument: The method of production is not material. Is doesn’t matter that the vinegar was made from dried apples or if it is inferior to apple cider. The Act does not require you to disclose the method of production.
5. Holding: Label was misleading as to the vinegar and therefore misbranding.
a. 403(b) – prohibition against offering food for sale “under the name of another food.”
b. Standard: need to seize the imitated product and “other food” for comparison.
6. What if they put pesticides on the apples? Do they have to disclose that on the label? No. could be part of the method of production.
iii. United States v 432 Cartons…Candy Lollipops
1. Facts: Food was 432 cartons of lollipops with legend in the inside of box “liquor flavored lollipops” but there was no alcohol in them. FDA said violation of 403(a) – false and misleading because implied that candy filled with alcohol and it’s not.
2. Holding: District ct judge decides that you have to read the labeling as a whole, cannot read in isolation. Read as a whole, it would convince a jury that it is not misleading.
3. Seizure actions usually decided by juries.
d. Labeling standard to assess whether food is misleading
i. “reasonable consumer standard”
e. Ingredient Labeling under 403(g)
i. Rule for listing: all of the ingredients of a food must be listed in descending order of predominance.
1. list by chemical name (not sweetener, etc)
2. spices, faloring, can be listed generically
3. chemical preservatives – must list fx and chemical name
4. 403(i) – amended 403(g) to require all ingredients in standardized food
i
trilab says because it’s derived from food. Ct says no, food that is something that is used for food.
ii. Holding: decided it was a drug because it was a drug because it affects the body and wasn’t used in a way food normally affects the body. This was blocking nutrition. Things used for food primarily for “taste, aroma, or nutritive value.” Used word “primarily” because stuff like coffee is used for something else.
iii. 201(f) food definition –
1. articles used for food and drink for man or other animals,
2. chewing gum, and
3. articles used for components of such article
iv. 201(g) drug definition covers articles “intended to affect the structure or any function of the body of man or animals”.
v. Fda wanted to make sure that drug definition was broad enough to cover things other than foods.
vi. Why are foods exempted? By their nature, they affect the structure and function of the body, eg calories.
vii. Congress passed the Dietary Supplement Act that made products like supplements food and let them make certain structure/function claims. This was an old case and back then this was a drug.
V. Food Santiation and Court Enforcement Model
a. Sanitation and Aesthetic Adulteration 403(a)(3) and (a)(4)
i. US v 484 Bags
1. Facts: coffee in a warehouse in New Orleans, hurricane damages the coffee and gets mold. Company puts it though the drier to dry it out. The FDA seizes the product under 21 USC 342(a)(3) – adulteration defitniion.
2. Rule 342(a)(3), adulteration – “if it consists in whole or part of any filthy, putrid or decomposed substance, or if it is otherwise unfit for food.”
3. FDA lost in the district court on two grounds:
a. It has to be otherwise unfit for food phrase. Appeals ct said that’s not true, that even if it could be fit for food, it cannot be moldy. Hinged on the fact that reasonable people cannot accept mold.
b. Insurance – keeping tough standards, creating assurance that even if something slips through, it is okay,
