1 legal and regulatory aspects moving forward presented by: zackler & associates (510) 834-4400
TRANSCRIPT
![Page 1: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/1.jpg)
1
Legal and Regulatory Aspects Moving
Forward
Presented by:
Zackler & Associates
www.foodlaw.com
(510) 834-4400
![Page 2: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/2.jpg)
2
Overview of Regulatory Sources and Methods
Regulatory Sources
Methods of Regulation
Zackler & Associates
![Page 3: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/3.jpg)
3
Regulatory Sources Federal Government/Executive
Branch Agencies State Government Local Government Private Legal Actions Industry Standards
Zackler & Associates
![Page 4: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/4.jpg)
4
Federal Government / Executive Branch Agencies
USDA Regulates the Farm
FDA Regulates the Processing, Distribution and Labeling of Food and Dietary Supplements
FTC regulates advertising
Zackler & Associates
![Page 5: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/5.jpg)
5
State Government(“Federalism”)
On-site food preparers (cafeterias, restaurants) and retailers
Who will regulate restaurants? Tougher state regulations Will restaurants seek federal
protection? Can ban food items or ingredients
(ephedrine) Off-label regulation
WebsitesZackler & Associates
![Page 6: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/6.jpg)
6
Local Government(“Localism”)
Zoning—(GMO farming bans in California counties)
Bans, labeling requirements?
Zackler & Associates
![Page 7: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/7.jpg)
7
Private Legal Actions Obesity Litigation
Pelman v. McDonald’s under N.Y. Unfair Practices Act
California Unfair Practices Act Hardee suit against makers of reduced
sugar cereals
Zackler & Associates
![Page 8: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/8.jpg)
8
Industry Standards
Trade Associations Unilateral Actions by Food
Processors McDonald’s eliminates supersizing;
and promotes exercise Kraft voluntarily limits advertising to
children Increased Regulatory Pressure
Zackler & Associates
![Page 9: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/9.jpg)
9
Means of Regulation Prohibition Remediation Warning labels
Zackler & Associates
![Page 10: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/10.jpg)
10
Prohibition Food Ingredients
Not practical No public acceptance Backdoor prohibition by warning label
(trans fat) Advertising Restrictions
Children• Legal Restraints (COPPA)• Voluntary Restraints (Kraft)
Zackler & Associates
![Page 11: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/11.jpg)
11
Remediation
McDonald’s approach End supersizing Put “healthy” alternatives on menu Encourage exercise
No voluntary change in product formulation or promotional activities
Not a viable alternative to warning labels and advertising restrictions
Zackler & Associates
![Page 12: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/12.jpg)
12
Warnings on Food Labels and Restaurant Menus
“Caution: this food contains excessive amounts of fat and may be hazardous to your health.”
Zackler & Associates
![Page 13: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/13.jpg)
13
Legal and Regulatory Aspects Moving Forward—Overview of Current Federal Regulation
Claims that can be made by foods and dietary supplements
Nutrient Content Claims vs. Health Claims (Statutory and Qualified)
Statutory vs. Qualified Health Claims Structure/Function: Food vs. Dietary
Supplement FDA vs. FTC Enforcement
Zackler & Associates
![Page 14: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/14.jpg)
14
Claims That Can Be Made By Food & Dietary Supplements
Claim Type FoodsDietary
Supplements
Nutritional Content YES YES
Health
Statutory YES YES
Qualified YES YES
Structure/Function
Nutritive YES YES
Non-nutritive NO YES
Zackler & Associates
![Page 15: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/15.jpg)
15
Statutory vs. Qualified Health Claims Procedure Standard of Approval Approved Claims
Zackler & Associates
![Page 16: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/16.jpg)
16
Statutory Health Claims—Standard of Approval
Significant Scientific Agreement (“SSA”) “There is significant scientific agreement
among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by the totality of the publicly available scientific evidence including evidence from well-designed studies conducted in a manner that is consistent with generally recognized scientific procedures and principles.”1
1 Source: Guidance for Industry, Qualified Health Claims in the labeling of Conventional Foods and Dietary Supplements, 12/28/2002)Zackler & Associates
![Page 17: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/17.jpg)
17
Statutory Health Claims—Approved Claims
21 CFR 101.72 to 101.83. Total 12 and include claims such as:
calcium and osteoporosis fiber and cancer fiber and heart disease (five of these
claims pertain to heart disease) folate and neural tube birth defects.
Zackler & Associates
![Page 18: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/18.jpg)
18
Qualified Health Claims—Legal Source
Decision of the U.S. Court of Appeals for the District of Columbia in Pearson v. Shalala which held that it is a violation of the First Amendment to prohibit food manufacturers from making scientifically based health claims that have not been approved by the FDA.
Zackler & Associates
![Page 19: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/19.jpg)
19
Qualified Health Claims—Procedure
File petition for review by FDA Response within 270 days
Zackler & Associates
![Page 20: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/20.jpg)
20
Qualified Health Claims—Standard of Approval
Totality of publicly available evidence supports the claim.
Uses a “B, C, D” grading system. B = evidence is not conclusive C = evidence is limited and not conclusive D = little scientific evidence
Source: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements, (07/10/2003)
Zackler & Associates
![Page 21: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/21.jpg)
21
Qualified Health Claims—Approved Claims
Qualified Claims About: Cancer Risk Cardiovascular Disease Cognitive Function Neural Tube Birth Defects
Zackler & Associates
![Page 22: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/22.jpg)
22
Qualified Health Claims—Approved Claims
Qualified Claims About Cancer Risk: Selenium & Cancer Antioxidant Vitamins & Cancer
Zackler & Associates
![Page 23: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/23.jpg)
23
Qualified Health Claims—Approved Claims
Qualified Claims About Cardiovascular Disease: Nuts & Heart Disease Walnuts & Heart Disease Omega-3 Fatty Acids & Coronary Heart
Disease B Vitamins & Vascular Disease Monounsaturated Fatty Acids From
Olive Oil and Coronary Heart Disease
Zackler & Associates
![Page 24: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/24.jpg)
24
Qualified Health Claims—Approved Claims
Qualified Claims About Cognitive Function: Phosphatidylserine & Cognitive
Dysfunction and Dementia
Zackler & Associates
![Page 25: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/25.jpg)
25
Qualified Health Claims—Approved Claims
Qualified Claims About Neural Tube Birth Defects and 0.8 mg Folic Acid & Neural Tube Birth Defects
Zackler & Associates
![Page 26: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/26.jpg)
26
Structure/Function Claims
Food vs. Dietary Supplements
Types of Claims Permitted Procedure Labels
Zackler & Associates
![Page 27: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/27.jpg)
27
Structure/Function—Food
Types of Claims Permitted: Nutritive Structure/Function (“S/F”)
claims (e.g. claims based on GRAS ingredients)
Procedure: No FDA approval or notice required
Labels: No FDA disclaimer required
Zackler & Associates
![Page 28: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/28.jpg)
28
Structure/Function—Dietary Supplements Types of Claims Permitted:
Nutritive S/F claims Non-nutritive S/F claims (e.g. antioxidants)
Procedure: Manufacturers must notify FDA of the claim
within 30 days after putting the supplement in retail distribution
Labels: “This statement has not been evaluated by
the Food and Drug administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
Zackler & Associates
![Page 29: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/29.jpg)
29
FDA vs. FTC Enforcement FDA
Public health, welfare—foods, drugs, cosmetics, dietary supplements
Prohibits adulteration/mislabeling FTC
Economic regulation Prohibits unfair methods of competition
or deceptive acts or practices affecting commerce
Zackler & Associates
![Page 30: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/30.jpg)
30
Legal and Regulatory Aspects Moving Forward Current Regulatory Topics
Low Carb Glycemic Index USDA Food Pyramid Obesity
Zackler & Associates
![Page 31: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/31.jpg)
31
Current Regulatory Topics—Low Carb
Claim was never approved by FDA as a nutrition or health claim (statutory or qualified)
“Industry civil disobedience”
Zackler & Associates
![Page 32: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/32.jpg)
32
Current Regulatory Topics—Low Carb
Why no FDA Action? Deregulatory mindset? Indecision? Low Carb is scientifically sound?
• FDA Working Group On Obesity recommended approval of low carb type nutrient content claims
Zackler & Associates
![Page 33: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/33.jpg)
33
Current Regulatory Topics—Low Carb
Why no FDA Action? (cont’d) Glacial responsiveness Inside the beltway politics Too many other things on FDA’s plate (e.g.
bioterrorism) PR problem with general public clamoring for
Low Carb food
Zackler & Associates
![Page 34: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/34.jpg)
34
Current Regulatory Topics—Glycemic Index
Which road will be taken? Formal approval by FDA as a
nutritional claim Low Carb (non-approval) model
Zackler & Associates
![Page 35: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/35.jpg)
35
Current Regulatory Topics—Obesity
FDA Working Group on Obesity “Calories Count”
Calories & Nutritional Labeling
Calories & Serving Size Regulations
Zackler & Associates
![Page 36: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/36.jpg)
36
Current Regulatory Topics—Proposed New Serving Sizes Effect on Nutritional Claims
Negative claims—“low in”
Positive claims—“high in”
![Page 37: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/37.jpg)
37
Current Regulatory Topics—USDA’s New “MyPyramid”Everyone’s Confused…
Zackler & Associates
![Page 38: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/38.jpg)
38
Current Regulatory Topics—USDA’s New “MyPyramid”
Based on the principles of the USDA’s 2005 Dietary Guidelines for Americans
Customized guidelines depending on age, sex and physical activity
Zackler & Associates
![Page 39: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/39.jpg)
39
Current Regulatory Topics—New USDA Food Pyramid 2005
![Page 40: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/40.jpg)
40
Current Regulatory Topics—New USDA Food Pyramid 2005
Primary challenge in using the new pyramid is how to formulate and market products that accurately reflect all of the variations among the various types of pyramids.
Zackler & Associates
![Page 41: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/41.jpg)
41
Current Regulatory Topics—New USDA Food Pyramid 2005
18 Year Old Male>60 min. of phys. act.
18 Year Old Female <30 min. of phys. act.
Calorie Pattern 3200 1800
Grains 10 ounces 6 ounces
Vegetables 4 cups 2.5 cups
Fruits 2.5 cups 1.5 cups
Milk 3 cups 3 cups
Meats & Beans 7 ounces 5 ounces
Oils 11 teaspoons 5 teaspoons
Extras--Sugars & Extra Fats
Limit to 650 Calories Limit to 195 Calories
![Page 42: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/42.jpg)
42
Legal and Regulatory Aspects Moving Forward—Conclusions More state and local regulation of
processed food industry More regulatory flexibility at federal
level More willingness by industry to
assert nutritional claims and health claims without explicit FDA approval
Zackler & Associates
![Page 43: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/43.jpg)
43
Zackler & Associates
www.foodlaw.com3824 Grand AvenueOakland, CA 94610(510) [email protected]@foodlaw.com
![Page 44: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/44.jpg)
44
Appendix
Zackler & Associates
![Page 45: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/45.jpg)
45
Nutrient Content
Legal Source§406(q) of the FDCA (21 U.S.C. 343(r)(1)(a))
ProcedurePetition process under §101.69 See Sample Petition
Definition
Characterizes the amount of nutrient or dietary substances in a food which has been scientifically proven to be either good (e.g. “high in Vitamin C”) or bad (e.g., “low fat”) for the human diet
Approved Claims
21 CFR Part 101, Subpart D (§101.54 - §101.69)
Zackler & Associates
![Page 46: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/46.jpg)
46
Health Claims
Legal Source
Statutory: §403(r) of the FDCA (21 U.S.C. 343(r)(1)(b)
Qualified: Pearson v. Shalala
ProcedureStatutory: Petition/Rule Making
Qualified: Petition/”Enforcement Discretion”
Definition
Characterizes the relationship between a food, or a food component, and a disease or health-related condition. Unlike a nutrient content claim, it is specific to a recognized medical condition.
Approved Claims
Statutory: 21 C.F.R. Part 101, Subpart E (§101.72 -§101.83)
Qualified: FDA website (not CFR published)
![Page 47: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/47.jpg)
47
Statutory Health Claims—Legal Source
§403(r) of the FDCA authorizes the Secretary of Health and Welfare to approve health claims
Zackler & Associates
![Page 48: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/48.jpg)
48
Statutory Health Claims—Procedure
Claims approved through a petition process involving public rule making under the Administrative Procedure Act (“APA”). Approved claims are published as regulations in the CFR.
See Sample Petition
Zackler & Associates
![Page 49: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/49.jpg)
49
Current Regulatory Topics—USDA Dietary Guidelines 2005 Food Groups to Encourage
Fruits, vegetables, whole grain, fat-free/ low fat dairy
Nutrients Fats Carbohydrates Sodium and Potassium
Zackler & Associates
![Page 50: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/50.jpg)
50
Current Regulatory Topics—USDA Dietary Guidelines 2005
Key Food Groups to Encourage Two cups of fruit and 2 1/2 cups of
vegetables per day for a reference 2,000-calorie intake
Choose a variety of fruits and vegetables each day (select from all five vegetable subgroups
Zackler & Associates
![Page 51: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/51.jpg)
51
Current Regulatory Topics—USDA Dietary Guidelines 2005
Key Food Groups to Encourage (cont’d) Consume 3 or more ounce-equivalents
of whole-grain products per day Consume 3 cups per day of fat-free or
low-fat milk or equivalent milk products
Zackler & Associates
![Page 52: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/52.jpg)
52
Current Regulatory Topics—USDA Dietary Guidelines 2005
Fats Consume less than 10% of calories from
saturated fatty acids and keep trans fatty acid consumption as low as possible
Keep total fat intake between 20-35% of calories
Select lean, low-fat, or fat-free meat, poultry, dry beans, & milk or milk products
Zackler & Associates
![Page 53: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/53.jpg)
53
Current Regulatory Topics—USDA Dietary Guidelines 2005
Carbohydrates Choose fiber-rich fruits, vegetables, and
whole grains often Choose and prepare foods & beverages
with little added sugars or caloric sweeteners
Reduce the incidence of dental caries by practicing good oral hygiene and consuming less sugar and starch containing foods and beverages
Zackler & Associates
![Page 54: 1 Legal and Regulatory Aspects Moving Forward Presented by: Zackler & Associates (510) 834-4400](https://reader036.vdocuments.us/reader036/viewer/2022070407/56649e315503460f94b223c6/html5/thumbnails/54.jpg)
54
Current Regulatory Topics—USDA Food Recommendations
Sodium & Potassium Consume less than 2,300 mg
(approximately 1 tsp of salt) of sodium per day
Choose and prepare foods with little salt.
Consume potassium-rich foods, such as fruits and vegetables
Zackler & Associates