Food Regulation and Policy
What are the two main aspects of DSHEA?
1)Excludes DS ingredients from the legal definition of "food additive" −No premarket approval (items before 1994); Presumption of safety 2)Categorizes all DS as "food" and excludes supplements that make S/F claims from drug definition S/F = general non-specific health claims
To be considered a Dietary Supplement what criteria must be met?
1. Intended use- 2. Ingredients 3. Form: 4. Label:Must be labeled as a DS 5. Exclusions: Not be a new drug- unless sold as a dietary supplement before 1994- or tobacco.
Name four of the 8 foods known to account for over 90% of food allergies.
1. Milk 2. Eggs 3. Fish 4. Shellfish (except mollusks) 5. Tree Nuts 6. Wheat 7. Peanuts 8. Soybeans
What are the four requirements from DSHEA for something to be labeled as a dietary supplement?
1. Products are taken by the mouth and contain dietary ingredients. 2. Must be categorized as food, not drugs or food additives. 3. Can not be represented as conventional food or a meal. 4. Must be labeled as a "dietary supplement".
Which organic labeling terms can use the USDA organic seal?
100% organic and Organic
How many days does the FDA have to review and rule on a proposed new health claim on a label?
540 days
Test market menu items can be on the market for a maximum of this many days
90
What is a credence claim?
A claim that a consumer will pay more for due to a higher quality product or a healthy food. Ex: organic, local, made in USA
What is the vending machine label requirement?
A sign close to each article of food or selection button disclosing the amount of calories.
"three grams of soluble fiber daily from whole grain foods, like honey nut cheerios, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Honey nut cheerios provides .75 grams per serving" is what type of health claim A. Authorized health claim B. Qualified claim C. Nutrient claim D. None of the above
A. Authorized health claim
What is the difference between a prebiotic and a probiotic?
A: Prebiotic is a non-digestible carbohydrate broken down by colon bacteria. Prebiotics are food for the bacteria. Probiotics are live, beneficial bacteria found in fermented foods that are used up in the digestive tract.
Q: What does the Principal Display Panel have to provide?
A: Portion of the package that is most likely to be displayed, presented, shown, oe examined; Common or usual name specified by standard of identity; Net quantity If it doesn't have a specified standard of identity use the descriptive and must not be misleading Ex) sandwich cookie
Who regulates the sell by and use by dates for milk and eggs?
Answer: Regulated by state governments, NOT the FDA
FDA requires premarket label approval, whereas FSIS does not require label pre-approval. True or False?
Answer: False! FDA does not require premarket approval; however, if an issue of non-compliance is found, they will issue a Letter of Warning, advising they change the label FSIS requires pre-approval
True or False: In order for a product to be labeled "organic," all ingredients in the product must be certified as organic and the processor must also be a certified organic handler.
Answer: False. Those are the guidelines for a product to be labeled "100 percent organic." A product may be labeled "organic" if 95% or more ingredients are certified organic, any nonorganic ingredients are allowed per the National List, and the processor is a certified organic handler.
The DSHEA has defined dietary supplements as drugs; true or false?
Answer: False; the DSHEA actually defines dietary supplements as a food.
Food Trucks are affected by the restaurant provision of law, meaning that they need to provide calories for their menu options. A. True B. False
B. False
Question: Which of the following does NOT need to be provided to the customer on a standard menu item? A: Total Calories B: Trans Fat C: Calcium D: Sodium
C Calcium
dietary supplements must be in one of these forms
Capsule Tablet Liquid Powder Softgel Gelcap OR - into products thatare in conventional food form and must not be represented as conventional form NOR as a sole item of a meal or diet.
two things the principal display panel must contain
Common or Usual Name specified by Std of Identity (if doesn't have a specified standard of identity use descriptive and must not be misleading ( ex. sandwich cookie) net quantity
Which of the following places is excluded from menu nutrition labeling laws? a. grocery stores b. trains c. cafeterias d. establishments within larger establishments
Correct Answer: B
What type of claim is the following statement: "high in fiber" A) Authorized Health Claim B) Qualified Health Claim C) Nutrient Content Claim D) Structure and Function Claim
Correct Answer: C
Compliance Dates for Menu and Vending Machines fall under this act
Creating Healthier Communities" Sect 4205 under the Patient Protection & Affordable Care Act
Which of the following is NOT a form of dietary supplement? A. Green Tea B. Aveeno Daily Moisturizing Lotion C. Vita fusion Omega-3 Gummies D. Prenatal Pills E. None of the following
E
Which of the following below is not one of the "labeling claims"? A. Qualified Health B. Authorized Health C. Nutrient Content D. Structure/Function E. All of the above are "labeling crimes"
E all of the above
compliance dates for vending machine labeling and menu labeling
FDA extended the compliance date to July 26, 2018. However, in July 2018, FDA proposed to amend the front-of-pack calorie labeling requirements for foods sold in glass front vending machines and proposed a compliance date of January 1, 2020.
What is FDA's role in Dietary Supplements? What are the three hurdles they have when they want to take enforcement?
FDA is responsible for taking action against any unsafe dietary supplement after it reaches market. 1.Burden of proof of adulteration- The FDA bears the burden of proof on each element in proving that dietary supplement is adulterated or misbranded. 2.Advanced notice of prosecution- FDA must provide manufacturer with the opportunity to present its side to the FDA BEFORE FDA proceeds with a case. 3.De Novo-Review- DSHEA eliminates deference to the viewpoint of the FDA when an adulteration case is brought to court.
True or False? -- The FDA preapproves dietary supplements prior to reaching the market
False! The FDA is responsible for taking action against dietary supplements after they reach the market and can take action against misbranding and adulteration. DS manufacturers are not required to register the supplement, and it can only be removed from market if determined poisonous/deleterious.
true or false The ingredients of a product can be listed in any order.
False. The ingredients should be listed in descending order by weight, where the heaviest ingredient is listed first.
What is DSHEA, whats so unique about this act?
It is the Dietary Supplement Health & Ed Act. It is unique because it is the first time that an act or amendment DID NOT expand FDA authority and rather de-regulated it.
Authorized health claims- what are they, examples?
Labeling statement that describes a relationship between a food or food component and its relationship to a disease or health-related problem Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life. Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis..
what allergens must be on the nutrition label
Milk•Egg•Fish •Crustacean Shellfish•Tree Nuts•Wheat•Peanuts •Soybeans
Nutrient Content Claims- what are they; examples?
Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite. "low sodium" or "contains 100 calories" "high in oat bran" "healthy, contains 3 grams of fat"
Menu labeling requirements:
On menus, menu boards (including drive-through menus) or on signs for foods on display •Number of calories listed as "calories" or "cal "•Adjacent to the name on the menu or to self-service food and foods on display •"Clearly associated with the item" •Can be a range for variable menu items
Difference in processed foods labeling of COOL?
Processed foods are excluded because they are Combined With Another Food Component like becoming a mixed food cup or experienced a Change of Character such as cooking or drying.
Qualified health claimes- what are they examples?
Qualified health claims (QHCs) are supported by scientific evidence, but do not meet the more rigorous "significant scientific agreement" standard required for an authorized health claim. "Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2."
What are S/F claims?
S/F = general non-specific health claims
WHO IS EXEMPT FROM NLEA REGULATION
Small Businesses (Two Exemptions Exists)1. Direct sales to consumers total annual sales of $500,000 or less. Low-Volume - number of employees (less than 10 full time) and number of units sold (less than 10,000)
True of False Under the Dietary Supplement Health and Ed Act (1994), dietary supplements were categorized as foods, not drugs.
True! Under this act, dietary supplements were considered to be a subcategory of food, but not regulated the same as food.
Are there times when menus/vending machines cannot have required information?
YES EXEMPTIONS INCLUDE: Food Trucks•School Menus if school participates with USDA nutrition program •Airplanes•Trains
Role of Intended Use- why is it important?
be intended to supplement the diet (that is, not intended to be a drug or a conventional food)
definition of intended use for dietary supplements
be intended to supplement the diet (that is, not intended to be a drug or a conventional food)
There are three main agencies involved in enforcing food related labeling laws. Pick which of the following answers lists the correct angencies a) FSIS, CDC, FDA b) FPLA, FDA, FPLA c) FDA, FSIS, FTC d) FDA, FSIS, USDA
c) FDA, FSIS, FTC
What year was the Proxmire Vitamin and Mineral Amendment added to the FD&C Act? a.) 1996 b.) 1984 c.) 1976 d.) 1963 e.) this amendment doesn't exist
c.) 1976
the ingredients in a dietary supplements must contain one of the following
contain one or more of: A vitamin A mineral An herb or other botanica lAn amino acid or A dietary substance for use by humans to supplement the diet by increasing the total dietary intake
what is the informational panel and what is in it
immediately to the right of PDP, the following must be placed if not already placed in the PDP •Ingredient List •Nutrition Labeling •Responsible Party- name and address of the manufacturer, packer, or distributer.
the words above the nutrition label on the box
information panel
this is below the nutrition label and is a list of everything in the food
ingredient list
NDI- What does it stand for and what is the definition?
it stands for New Dietary Ingredient. the definition is "a dietary ingredient that was not on the market in the United States before October 15, 1994."
this is the term for the mass of the food on the bottom right of the package
net weight
this label is the big black and white label that describes the nutrient and calorie content. of a food
nutrition facts panel
what is the principal display panel?
portion of the package that is most likely to be displayed, presented, shown, or examined.
the name for the big icon on the front of a food box such as the Kraft logo on a box of Mac and cheese
principal display brand
this is the term for the name of a general product like elbow macaroni
standard of identity
True or False. Both the FSIS and FDA require label approval. Answer: False. Only FSIS requires label approval. The FDA does not, but they issue a warning advising they change the labels.
true
True or False: Under the Tarriff Act of 1930, all foreign articles imported into the US must be marked with the country of origin for the ultimate purchaser.
true
True/ False The statement: "2,000 calories a days is used for general nutrition advice, but individual calorie needs may vary." is required on a menu.
true
