labeling hot topics - naturally boulder · 2017-04-11 · labeling hot topics naturally boulder...
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Labeling Hot Topics
Naturally Boulder March 29, 2017FDA Compliance Simplified
Sponsored by All Packaging Company
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Labeling Basics
• All labels must include 3 basic elements:– Statement of identity– Net quantity of contents – Signature line
• Labels for FDA regulated products must also have – Ingredient lists– Directions for safe use or safe handling statements– Warnings are often required
• Labels for foods must also have Nutrition Facts Panels– Dietary supplements need Supplement Facts Panels
• Note that the placement and font sizes are dictated by regulation.
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FDA Regulations can feel like a restrictive box but think of them more
like scaffolding on which you build your label.
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Anything you put on your label is subject to regulation.
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Any text can be viewed as a claim.
• All claims must be truthful, not misleading, supported by data and fair.
• The Federal Trade Commission monitors marketing claims. They are an independent agency and their requirements often go beyond what is required by FDA and USDA regulation.
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FDA does not recognize “Functional Foods” as a product category
Products are regulated based on Intended use and Perceived Risk
FDA draws bright lines between foods, dietary supplements and drugs.
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FDA’s Labeling and Nutrition Page
• * Terms such as "functional foods" or "nutraceuticals" are widely used in the marketplace. Such foods are regulated by FDA under the authority of the Federal Food, Drug, and Cosmetic Act, even though they are not specifically defined by law.
• https://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm2006860.htm
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Pitfalls to Avoid
• Ingredients that are not permitted
• GRAS (Generally Recognized as Safe) applies only to the exact preparation, product use and levels of use delineated in the notification
• Even phytonutrients naturally occurring in foodstuffs require safety review when the are purified or concentrated.
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Pitfalls to Avoid
• Statements that are therapeutic in nature or that mention abnormal health conditions are only permitted on products that have undergone FDA pre‐approval such as drugs and devices.
• If your label makes drug‐like claims FDA will expect you to follow the drug regulations.
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Pitfalls to Avoid
• Alteration of required label elements.
• Changes to required language• Creative placement• Beautification of the nutrition facts box
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Pitfalls to Avoid
• Claims about recycling, carbon footprint, sustainability, etc.
• See FTC’s “Green Guides” on how to make compliant environmental claims
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Pitfalls to Avoid
Improper “Made in the USA” statements
• “All or virtually all” of the ingredients must be made in the United States.
• “Made in the USA” claims are considered true only if the majority of the ingredients, based on their percentage in the product, their cost and their importance to the function of the product are also made in the USA.
• See FTC’s “Complying with the Made in the USA Standard”
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New Nutrition Facts Box
• Regulations published May 27, 2016.• Became effective July 26, 2016• Companies with sales > $10 Million must comply by July 26, 2018
• Smaller companies must comply by July 26, 2019.
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FDASimplified.com
New Nutrition Facts Box
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New Nutrition Facts Box
All packages that contain 2 to 3 servings must declare the nutrition information for a single serving and for the entire package.
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New Nutrition Facts Box
Change in order and prominence of serving size informationSome serving sizes were changed as well
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New Nutrition Facts Box
Calorie declaration much more prominentFat Calories no longer declared
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New Nutrition Facts Box
Lower Daily Value for Sodium
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New Nutrition Facts Box
New definition of dietary fiberIncludes fibers in the fruits & vegetables as well as beta‐glucan, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose.
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New Nutrition Facts Box
Total sugarsAdded sugars
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New Nutrition Facts Box
Vitamin D & Potassium now listedThe mg/mcg amounts declared
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New Nutrition Facts Box
Shortened footnote
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Tips for converting to the new facts box
• Take time to review your ingredients, formulations & processes.
• Have your recipes in weight rather than volume measures.
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Tips for converting to the new facts box
• New data is required for Vitamin D, Potassium and Added Sugars
• New units to declare the fat soluble vitamins.
• Ask your suppliers for new data on any characterizing / unique ingredients
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Tips for converting to the new facts box
• Check for new serving size; report in household & metric units.
• Pack size in standard and metric units
• Package/label size
• Review the rest of the layout and claims for compliance with FDA regulations.
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What would you like to know?
Evelyn CadmanFDA Compliance Simplified [email protected] 303‐432‐1605
Thanks All Packaging!