Food Label/Dietary Supplement Regulations

NLEA Nutrition Labeling and Education Act passed by congress in 1990  Regulations written 1993  Manufacturer compliance Spring 1994

Exceptions Small business Foods for immediate consumption, deli and bakery items Foods of no nutritional consequence (spices/coffee/tea) Infant formula/medical food Small packages (require 1-800#)

Required Elements Serving size (common and g) -standard reference sizes for 139 products Servings/container Total calories/calories from fat Total fat (g) Saturated fat (g)

Cholesterol (mg) Sodium (mg) Total carbohydrate (g) (includes starch, sugar, and fiber) Dietary Fiber (g) Sugars (g) (includes simple sugars from natural and added sources)

Trans Fats (g) Will be listed after saturated fat Will not have a %DV Manufacturers must comply by Jan. 2006

Reference Values Generic Term = Daily Values (DVs) 2 sets of Daily Values 1. RDIs (Reference Daily Intakes) – label standards for micronutrients Required: Vitamin A and C, iron, calcium

2. DRVs (Daily Reference Values) – label standards for macronutrients, fiber, sodium, cholesterol Based on a 2,000 kcal diet 30% of kcals fat 10% of kcals – saturated fat 60% of kcals carbo.

11-12 g fiber/1,000 kcals 2,400 mg sodium 300 mg cholesterol

Activity Estimate calorie needs Healthy body weight (lb) X 10 = baseline calories Baseline calories X 1.3 – sedentary 1.4 – light activity 1.5 – moderate activity 1.6 or more - active

Ingredients Still listed by weight (descending order) Changes: FDA-certified colors additives – use name Sources of protein hydrolysates revealed Caseinate identified as a milk derivative % real juice

2 Types of Claims 1) Nutrient-Content Claims 2) Health Claims

Nutrient-Content Claims Highlighting and emphasizing something about the nutritional content of the food (fat, cholesterol, fiber, micronutrient, etc.) Statements are well-defined.

Health Claims Approved statements that describe a relationship between a food or substance in food and a disease or condition 14 approved health claims FDA requires SSA (significant scientific agreement) in approving claims Food must also have at least 10% of DV for A, C, iron, Ca, protein, fiber and no more than 20% of DV fat, sat’d fat, cholestol, sodium

In 1998 – President Clinton approved use of “Authoritative Health Claim Statements” for food labels May use health claims from groups like NIH, CDC, NAS

Raw Foods? Voluntary program for markets to provide information if form of poster/brochures for 20 most commonly consumed fruits/veges 20 most commonly consumed fish categories of beef/poultry

July 1994 – added safe handling of meat instructions

How accurate are labels? Review results from 1996 study

Restaurants Are exempt from NLEA unless they make claims about 1) Nutrient-content 2) Health claim If customer inquires – they must provide nutritional information

Other actions Slight changes in labeling of Olestra products – no more warning label about GI problems (pg reader) Look for a grading system for health claims (pg reader)

Qualified Health Claims B-D Review some examples

Dietary Supplements

Dietary Supplement Health and Education Act DSHEA (1994) Congress passed law  Regulations written (1997)  Spring 1999 (new labels)

Provisions of Bill 1) Defined what a dietary supplement is “is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients”

2) Provides framework for assuring safety

Safety DSHEA does not require that supplements are shown to be safe or effective before they are marketed. Manufacturers must notify FDA of intent to market 75 days prior and submit info. that supports their conclusion that a new supplement can reasonably be expected to be safe.

True safety burden falls on FDA FDA is only allowed to restrict a supplement if it poses a “significant and unreasonable risk” under the conditions of use as stated on the label. FDA must have substantial reports of adverse effects before they may take any action.

Oct Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) added an amendment (#2013) DSHEA providing $1 million to FDA for safety enforcement Sales: $17 billion in 2000

3) Provides for Good Manufacturing Practices

Quality DSHEA gives FDA authority to establish good manufacturing practices (GMPs) In review - none currently exist March 2003 – proposed new regulations for the establishment of current good manufacturing practices (CGMPs)

Does supplement contain what label claims it has??? - What is appropriate dose for active ingredient? (unclear) -adulteration, substitution, contamination and additives may be present but not listed on the label -have been some reports of outright fraud

Quality? Consumer lab provides independent testing of quality US Pharmocopeia – standards that over- the-counter drug companies use

National Nutritional Foods Association (NNFA) -- a trade organization encompassing about 1000 producers as well as retailers NFA-GMP-seal.html

4) Established the Office of Dietary Supplements and Alternative Medicine of NIH

5) Regulates Label Information

Required Elements 1) Product Name Must identify that product is a dietary supplement 2) Serving size and daily dose 3) Ingredients List – in supplements fact box and “other ingredients”

4) Percent Daily Value For nutrients with a DV – must show mg/  g amount and %DV

5) Claims

Claims 1. Nutrient - content claims must follow regulations as stated in NLEA “High in calcium” mg or more/serving “Excellent source of C” - 25 mg or more “High potency” - 100% of DV for nutrients

2. Health Claims May use any of the 14 approved Health Claims as stated in NLEA FDA required SSA (significant scientific agreement) in approving claims

“Calcium reduces the risk of osteoporosis” “Soluble fibers may reduce the risk of CHD” “Plant sterols reduce the risk of heart disease” “Folic acid reduces the risk of having a child with a brain or spinal birth defect”

The Gray Zone 3. Structure/Function Claims Allowed to make claims about how the supplement supports or promotes healthy functioning of the body Claim must not suggest that the supplement treats, prevents, or mitigates a disease

Exemptions: common conditions associated with natural states or processes that do not cause significant or permanent harm e.g., hot flashes, mild memory problems, hair loss associated with aging, acne

Must carry disclaimer statement “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”

May sell a product with a claim as long as FDA is notified within 30 days of market Manufacturer determines if claim is scientifically substantiated Burden of proving inadequate substantiation of claim in responsibility of FDA.

Helps maintain cardiovascular function Protects against heart disease Promotes healthy cholesterol level Lowers cholesterol level Promotes healthy joints Reduces pain of arthritis Supports regularity, healthy intestinal flora Alleviates chronic constipation; laxative

Promotes urinary tract health Prevents urinary tract infections; improves urine flow in men over the age of 50; diuretic Reduces stress and frustration Herbal prozac Improves memory Treats dementia

Center for Science in the Public Interest (CSPI) “this proposal was merely a futile bureaucratic exercise in hairsplitting that did little to protect the consumer.”

Recent Action December 2003 – Immediate consumer safety alert on ephedra and rule to come on banning the sale of ephedra-containing products

Suggestions for the practitioners Direct link to FDA Reliable sources on supplements