FOS4731 Exam 2 Study Guide
Food Definition Under FDCA
(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
Alcoholic beverage labeling regulation - under what act? By which agency?
Alcohol and Tobacco TTB of US Dept of Treasury has jurisdiction over the labeling of alcoholic beverages under the Federal Alcohol Administration Act. • Certificates of label approval or Certificates of exemption are required • FDA regulates wine products containing less than 7% alcohol (e.g. wine coolers) • Voluntary allergen declaration (ANPRM published in 2006)
What would make food deemed "misbranded"?
Food, Drug, and Cosmetic Act (21 USC §301) Sec. 403. A food shall be deemed to be misbranded : (a) If its labeling is false or misleading in any particular,... (b) If it is offered for sale under the name of another food. (c) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated. (d) If its container is so made, formed, or filled as to be misleading... Misbranding Sec. 403. A food shall be deemed to be misbranded : (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 as provided by section 401, unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard, and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food. Misbranding Sec. 403. A food shall be deemed to be misbranded : (h) If it purports to be or is represented as - (1) a food for which a standard of quality has been prescribed by regulations a provided by section 401, and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or (2) a food for which a standard or standards of fill of container have been prescribed by regulations as provided by section 401, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard...
What is serving size? How is it established (i.e. based on what?)
How much the average person typically consumes in one sitting, based on what perople are actually eating
Acts/Regulations related to food/nutrition labeling
Kordel v. United States: • Drugs and the literature had a common origin and common destination • Literature was used in the sale of the drugs, and the use of the drugs was explained in nowhere else → essential supplement • Drugs and the literature are therefore interdependent. • "Accompanying such article" is not restricted to labels that are on or in the article on package United States v. 24 Bottles "Sterling Vinegar & Honey": • When activities are not integrated, the courts are less likely to find that literature is labeling. • The court found that the books were not for the purpose of increasing the sales of the product.
What is MOU? What can be an example?
Memorandum of understanding can be established between agencies
Definition of principal display panel (PDP)
Portion of the package label that is most likely to be seen by the consumer at the time of purchase Alternate PDP Required info that should appear on the PDP: − Statement of Identity (product name) − Net quantity (metric and in-lb units)
Primary intent of Food, Drug and Cosmetic Act (FDCA)
Prohibition in interstate commerce of foods, drugs, devices or cosmetics that are ADULTERATED OR MISBRANDED
Definition of "interstate commerce"
Prohibits the introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded. • Both elements (i.e. interstate and commerce) of the definition must be fulfilled. • Interstate means across a state line, or into a state from anywhere out of state • Commerce means commercial activity with respect to goods.
Food, Drug and Cosmetic Act (FDCA) Intro
Regulates food, drungs, medical devices, & cosmetics. Depending on the classification of the product, regulation can be quite different. DEFINITION IS KEY
Definition of label/ labeling
Required information must be conspicuously displayed − Principal Display Panel (PDP) − Information Panel
Importance of nutrition
lol....
Definition of information panel
Area contiguous to and immediately to the right of the PDP Required info that should appear on the Information Panel: − Ingredient list − Nutrition labeling − Responsible party (name and address of the manufacturer, packer, or distributor)
What is the primary intents for the revised nutrition labeling requirements?
Refreshed Design • Increasing type size for Calories, Servings per container, and Serving size • Require to declare the amount of potassium, Vitamin D, calcium and iron (Vitamins A, C for voluntary declaration) • Change in footnote - *The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice. FDA Revision of the Nutrition Labeling Final rule published in May 2016. Reflecting updated information • Added sugars • Removed "Calories from Fat" • Disclose Vitamin D, potassium, calcium and iron (required) • Updated daily values for sodium, fiber, and vitamin D
cosmetic Definition Under FDCA
(1) Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) Articles intended for use as a component of any such articles; except that such term shall not include soap.
Dietary Supplement Definition Under FDCA
(1) Means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), OR (E); ......
Drug Definition Under FDCA
(A) articles recognized in the official United States Pharmacopoeia...; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) .....A food or dietary supplement for which a claim.... is made...is not a drug solely because the label or the labeling contains such a claim...
Medical Devices Definition Under FDCA
(h) The term "device" ... means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is - (1) recognized in ...; (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or (3) Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Importance of definition in enacting FDCA (why is the statutory definition important?)
Clear and concise definitions of terms are important as they can provide the scope and boundaries by the legal document.
Jurisdictional authority of other agencies (which agencies do what?)
Congress delegates power and authority to federal regulatory agencies. Must stay within scope or boundaries (aka jurisdictional limits) FDA gets its power to regulate food, drug, and cosmetic industries from the FDCA
Food allergens - what are major allergens?
Food Allergen Labeling & Consumer Protection Act of 2004 • Require a food that contains or derives from a major food allergen to specifically indicate the information on the label • Major food allergens - Milk, eggs, fish, crustacean, tree nuts, wheat, peanuts, soybeans • Allergens in flavoring, coloring or incidental additives should be labeled. • Gluten-free: 20 ppm or less
Which food requires warning statement? About what?
Food products that require warning statements: • Self-pressurized containers • Certain protein dietary supplements • Iron dietary supplements • Shell eggs • Aspartame (PKU warning) • Unpasteurized fruit and vegetable juices • Foods containing dry or incompletely hydrated psyllium seed husk • https://www.govinfo.gov/content/pkg/CFR-2010-title21- vol2/pdf/CFR-2010-title21-vol2-sec101-17.pdf
What information should be included in simplified label format?
When the food contains insignificant amounts of seven or more of the mandatory nutrients and total calories Must list total calories, total fat, total carbohydrates, protein, and sodium
Food Additive Definition Under FDCA
any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), ... as having been adequately shown through scientific procedures to be safe under the conditions of its intended use; except that such term does not include - (1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or (2) a pesticide chemical; or (3) a color additive; or .....
What is dual declaration? How is it used?
for products that are larger than a single serving but that could be consumed in one sitting or multiple sittings
What information is required for small-sized package?
s (less than 12 sq.in) • No nutrition information (required if claims are made) • Must provide contact information • For voluntary provision: - Small type size - Tabular or linear format
How would food allergen be declared? (there were two different ways - refer to PPT slide)
• By stating the common or usual name of the food allergen in the list of ingredients followed in parentheses by the name of the food source from which the major food allergen is derived • By stating "contains" followed by the name of food source from which the major food allergen is derived is printed immediately after or is adjacent to the list of ingredients
Fair Packaging and Labeling Act (FPLA) - primary intention, administrative agency/agencies
• Enacted in 1966 (15 USC 1451) • Prevent unfair and deceptive trade practices • Provide consumers with accurate information on the product • Administered by FDA and Federal Trade Commissions (FTC) • FDA labeling regulations on 21 CFR §101, covering both FDCA and FPLA
Labeling requirements under the USDA - what should be on the label and how is it different from the FDA requirements?
•Regulations specify where on the label some of the features must be located Principal Display Panel (PDP)•9 CFR 317.2(c) and (d), 9 CFR 381.116 Information Panel (IP)•9 CFR 317.2 (m), 9 CFR 381.116(c) 1.Product name 2.Inspection legend and establishment number 3.Handling statement 4.Net weight statement 5.Ingredient statement 6.Address line 7.Nutrition facts 8.Safe handling instructions
Differences between inspection and grading
•USDA grading -Marketing tool -Agricultural Marketing Service (AMS) -Optional -Paid for by the packer •USDA inspection -Food safety assessment -Food Safety Inspection Service (FSIS) -Mandatory -Paid for by tax dollars
What information is required to be on PDP and Informational panel? (should understand specific requirement for each information required on PDP and informational panel)
− Statement of Identity (product name) − Net quantity (metric and in-lb units)