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Frequently Asked Regulatory Questions


Adulteration, Sanitation, and Filth
Advertising
Alcohol in Candy
Fortification, Dietary Supplements, and 'Nutraceuticals'
General
Good Manufacturing Practices and HACCP
Imports and Exports
Inspections
Labeling
Recalls/Market Withdrawals

Have a question not addressed here? Contact Alison Bodor.


Adulteration, Sanitation, and Filth

  • Are Defect Action Levels legally binding? - Access Restricted

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  • What is the best way to ensure that we comply with Defect Action Levels? - Access Restricted

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  • What are Defect Action levels for some of the most common confectionery product ingredients? - Access Restricted

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  • What does it mean for a product to be “adulterated”? - Access Restricted

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  • What is “economic adulteration”? - Access Restricted

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  • How does the FDA regulate the purity of food ingredients? - Access Restricted

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Advertising

  • Do the FDA rules on nutrient content claims and health claims in labeling also apply to nutrient content claims and health claims made in advertising? - Access Restricted

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  • How does the NAD process work? - Access Restricted

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  • Is a company’s website advertising or labeling? - Access Restricted

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  • Do the FDA rules on nutrient content claims and health claims in labeling also apply to nutrient content claims and health claims made in advertising? - Access Restricted

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  • How can I challenge a competitor’s advertising claims? - Access Restricted

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  • What government agencies regulate advertising? - Access Restricted

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  • What are the general requirements for advertising? - Access Restricted

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  • What is “puffery”? - Access Restricted

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Alcohol in Candy

  • May candy contain alcohol? If so, are there restrictions as to how much? Are there additional labeling requirements for candy containing alcohol? - Access Restricted

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  • What are the state regulations regarding alcohol in confectionery - Access Restricted
    Chart of state-by-state regulations for alcohol in confectionery and candy.

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Fortification, Dietary Supplements, and 'Nutraceuticals'

  • Does FDA permit fortification of candy with nutrients (e.g., chocolate chews with added calcium)? - Access Restricted

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  • How are dietary supplements regulated? - Access Restricted

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  • What are “nutraceuticals”? - Access Restricted

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  • How does FDA determine whether a product is a conventional food or a dietary supplement? - Access Restricted

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  • May a botanical or other “novel” ingredient be added to a confectionery product (e.g., gingko biloba added to a jelly bean)? - Access Restricted

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  • What is a “dietary supplement”? - Access Restricted

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General

  • What U.S. government agencies have responsibility for regulating the confectionery industry? - Access Restricted

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  • What are FDA’s inspection and compliance priorities insofar as they affect the confectionery industry? - Access Restricted

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  • In general, how likely is it that our firm will be subject to action by FDA? - Access Restricted

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  • What are FDA’s general regulatory and enforcement powers? - Access Restricted

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  • How to submit a question - Access Restricted

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  • My firm has some candy products that do not meet our usual quality standards or that are not correctly labeled. Can we give these products away to charity? - Access Restricted

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  • Sometimes I see my competitor’s products on retail shelves that do not follow all FDA labeling requirements, what can I do? - Access Restricted

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Good Manufacturing Practices and HACCP

  • What is HACCP (Hazard Analysis and Critical Control Points)? - Access Restricted

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  • Does FDA require HACCP for the confectionery industry? - Access Restricted

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  • Should we consider instituting HACCP in our plant? - Access Restricted

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  • What are FDA’s Good Manufacturing Practices (GMPs)? Do they apply to the confectionery industry? - Access Restricted

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  • FDA’s GMP regulations are very general and include terms like “suitable” and “adequate.” How do we know if our firm is in compliance with non-specific language like this? - Access Restricted

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Imports and Exports

  • Are there specific requirements for exported products? - Access Restricted

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  • Does FDA require all imported products to be labeled with their country of origin? - Access Restricted

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  • What specific rules apply to imported products? - Access Restricted

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  • If my confectionery plant or supplier is in another country (e.g., Canada or Mexico), can FDA inspect the plant? - Access Restricted

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  • Is a product that is sold in Western Europe automatically okay to be sold in the U.S.? - Access Restricted

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  • How can I find the quotas/tariffs applicable to specific products (sugar, cocoa, nuts, guar gum, etc.)? - Access Restricted

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  • Where can I get additional information about exporting, and about the requirements of customer countries? - Access Restricted

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Inspections

  • What powers do state/local governments have regarding food? - Access Restricted

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  • What are some of FDA’s inspection priorities specific to confectionery plants? - Access Restricted

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  • What is FDA’s inspection authority? - Access Restricted

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  • What typically happens at the beginning of a routine FDA inspection? - Access Restricted

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  • What are my rights and responsibilities in the event of an inspection? - Access Restricted

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  • At the end of an inspection, if FDA asks the plant manager to sign an affidavit, is he required to? - Access Restricted

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  • Can FDA make tape recordings inside our plant? - Access Restricted

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  • FDA inspected my plant and left us with a “Form 483" expressing concerns. What is this? What should we do about it? - Access Restricted

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  • Following an inspection, we received a Warning Letter. What do we do? - Access Restricted

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  • During FDA inspections, our firm is sometimes asked for documents, like product recipes, SOPs, customer lists, and complaint files. Do we have to provide this information to FDA? - Access Restricted

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  • If FDA comes to conduct an inspection, can we ask the inspector to come back on a day when the plant manager (who usually accompanies the FDA inspectors) is available? - Access Restricted

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  • Do we have to allow FDA to take photographs inside our plant? - Access Restricted

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Labeling

Claims

  • What are the requirements for sugar content claims? - Access Restricted

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  • What are the requirements for fat content claims? - Access Restricted

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  • What is a health claim? - Access Restricted

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  • When may a candy be labeled as having all “natural” ingredients? - Access Restricted

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  • What is a nutrient content claim? - Access Restricted

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  • Is eligibility for a nutrient content claim based on the level of the nutrient per RACC or per serving size? - Access Restricted

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  • Can confectionery products make health claims? - Access Restricted

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  • May a product label make a statement about the level of a nutrient that does not have a Daily Value (e.g., omega-3 fatty acids, polyphenols)? - Access Restricted

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  • May a product label make a claim about a value-added ingredient? - Access Restricted

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  • Is "sugar free chocolate" a permissible term to use? - Access Restricted

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  • May a product be labeled “GMO-free,” “non-GMO,” or “contains no genetically modified ingredients”? - Access Restricted

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  • What ingredients must be listed on the label? - Access Restricted

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  • Is there a time limit for “new” claims? - Access Restricted

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Country-of-origin Marking

  • How should country-of-origin marking appear on the label? - Access Restricted

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  • What requirements have to be met to label a product “Made in the U.S.A.”? - Access Restricted

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  • When are disclosure statements required to accompany nutrient content claims? - Access Restricted

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  • For imported products, must the label indicate the country of origin? - Access Restricted

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Exemptions

  • Are any confectionery products exempt from labeling requirements? If so, which ones? - Access Restricted

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General

  • If a U.S. consumer purchases a foreign product via the Internet/fax/mail, does that product have to comply with U.S. labeling requirements? - Access Restricted

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  • Are foreign language words permitted on the label? - Access Restricted

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  • May label information be placed on the bottom of a candy box, so as not to detract from the product’s appearance on retail shelves? - Access Restricted

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  • If a manufacturer changes its product so that the label is no longer accurate, is there a “grace period” during which the manufacturer may still use the old labeling? Do you need permission from FDA? - Access Restricted

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  • If a food label statement does not violate the FDA regulations, does that always mean it is permissible? - Access Restricted

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  • My firm distributes candy that is made for us by a different firm. Are we responsible for the proper labeling and composition of this candy? - Access Restricted

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  • Where on the label must “mandatory information” be presented? - Access Restricted

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  • What label information is optional? - Access Restricted

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  • What information must be presented on the food label? - Access Restricted

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  • May required label information be placed on a “hang tag”? - Access Restricted

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  • What is the “information panel”? - Access Restricted

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  • What is the “principal display panel”? - Access Restricted

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Ingredient Declaration

  • Do certified color additive lakes have to be declared separately from certified color additives? - Access Restricted

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  • How should color additives be declared? - Access Restricted

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  • What ingredients must be listed on the label? - Access Restricted

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  • Is “and/or” labeling, or similar labeling, permitted in the ingredients declaration? - Access Restricted

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  • How should evaporated cane syrup be labeled? - Access Restricted

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  • If a product contains genetically modified ingredients (e.g., corn starch from genetically modified corn), does the ingredients declaration have to state this fact? - Access Restricted

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Net Content Declaration

  • Does the net contents declaration have to be stated in both pounds/ounces AND metric measures? - Access Restricted

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Nutritional Facts

  • What are the “rounding” rules for Daily Value percentages? - Access Restricted

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  • What rules govern “rounding” of nutrient amounts? - Access Restricted

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  • How do I choose the appropriate display option for the Nutrition Facts panel? - Access Restricted

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  • Under what circumstances are “Polyunsaturated fat” and “Monounsaturated fat” required to be declared in Nutrition Facts? - Access Restricted

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  • How do you know whether to round up or down? - Access Restricted

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  • Under what circumstances are “Sugar alcohols” required to be declared in Nutrition Facts? - Access Restricted

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  • How should a candy manufacturer obtain the information it needs to provide nutrition labeling? - Access Restricted

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  • When may abbreviations for nutrients be used? - Access Restricted

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  • The Nutrition Facts panel may have different layouts. How does a manufacturer determine the appropriate layout for its product? - Access Restricted

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  • How do I choose the appropriate format for the Nutrition Facts panel? - Access Restricted

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Product Name

  • When is it necessary to provide flavor labeling in connection with the product name? - Access Restricted

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  • When can a product that contains cocoa, but no chocolate, have a product name that uses the word “chocolate” (e.g., “chocolate milk”)? - Access Restricted

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  • What rules govern flavor labeling? - Access Restricted

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  • What are permissible statements of identity? When are qualifying terms required with a statement of identity? - Access Restricted

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  • What confectionery products and ingredients have names prescribed by FDA regulation (i.e., standards of identity, “common or usual name” regulations)? - Access Restricted

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  • If the product name indicates geographic origin (e.g., “Turkish taffy”), must the product be made in that place? - Access Restricted

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  • How should the product name appear? - Access Restricted

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Serving Size

  • Is the FDA going to change the RACC’s and serving sizes for candy products? - Access Restricted

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  • How much leeway does a firm have to determine whether a confectionery product is a “single serving” (e.g., a large candy bar)? - Access Restricted

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  • What are the RACC’s for confectionery products? - Access Restricted

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  • How do we determine a confectionery product’s serving size? - Access Restricted

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  • What is the difference between “reference amount customarily consumed” and “serving size”? - Access Restricted

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Special Product Categories

  • What labeling requirements apply to candy sold in bulk containers at retail? - Access Restricted

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  • Are mail order sales of candy covered by the food labeling laws? - Access Restricted

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  • What are the labeling requirements for gift assortments? What if the gift assortment is custom-made in the retail establishment? - Access Restricted

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  • Is less label information permitted for packaged products that are not sold to consumers, such as packaged candies (e.g., dinner mints, hard candies, chocolates) served in restaurants or on airlines? - Access Restricted

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  • Is less label information permitted for confectionery products sold in vending machines? - Access Restricted

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  • What labeling requirements apply to shipping containers or cartons? - Access Restricted

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Warnings

  • What warning statement is required for products containing mannitol? - Access Restricted

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  • What ingredients trigger warning or notice statements? - Access Restricted

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  • What warning statement is required for products containing sorbitol? - Access Restricted

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  • Is a warning statement required for products containing saccharin? - Access Restricted

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  • What warning statement is required for products containing aspartame? - Access Restricted

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  • What warning statement is required for products containing psyllium husk? - Access Restricted

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Recalls/Market Withdrawals

  • Why designate a recall contact person at each supplier and customer? - Access Restricted

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  • What is the difference between a “recall” and a “market withdrawal”? - Access Restricted

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  • What are the Recall Coordinator and Recall Team and what do they do? - Access Restricted

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  • What procedures should be established for investigating product complaints? - Access Restricted

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  • What procedures should be established to capture recall requests? - Access Restricted

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  • Why and how should I select a reputable outside laboratory? - Access Restricted

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  • Why select experienced legal or regulatory counsel? - Access Restricted

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  • When notifying FDA of a voluntary recall, what information should be provided? - Access Restricted

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  • If a candy manufacturer or distributor decides to conduct a “voluntary” recall, should it seek FDA’s advice and concurrence on how to proceed? - Access Restricted

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  • Why should a company comply with an FDA “request” for a recall? - Access Restricted

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  • If a candy manufacturer or distributor decides to conduct a “voluntary” recall, should it notify the FDA? - Access Restricted

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  • What are some ways to prepare for the possibility of a recall? - Access Restricted

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  • Why designate a recall contact person at each supplier and customer? - Access Restricted

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  • Why is it a good idea to obtain FDA’s concurrence on how to recall a product that poses a health hazard? - Access Restricted

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  • What is meant by “recall classification” and “recall depth”? - Access Restricted

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  • Why conduct practice recalls? - Access Restricted

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  • What is adequate insurance coverage for a recall? - Access Restricted

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  • Why establish a coding system to identify products by production lot? - Access Restricted

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  • What is meant by “knowing your operations”? - Access Restricted

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  • What are the most likely reasons that confectionery products need to be recalled? - Access Restricted

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  • Is there such a thing as a mandatory recall of a confectionery product? - Access Restricted

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  • If my company recalls a product, what are our responsibilities? - Access Restricted

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  • Under what circumstances is a recall necessary? - Access Restricted

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