Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans How can companies prepare for the unannounced audits that the MDR will require notified bodies to conduct? 1.65K viewsMedical Device 0 Votes 1 Ans What do you think companies can expect during audits from a risk management perspective? 1.63K viewsMedical Device 0 Votes 1 Ans We know the big companies have a lot of money and resources to throw into the transition. How will MDR affect smaller companies? 1.48K viewsMedical Device 0 Votes 1 Ans From a practical perspective, what do those companies need to be doing? 1.29K viewsMedical Device 0 Votes 1 Ans How does Brexit play into the MDR changes? 1.54K viewsMedical Device 0 Votes 1 Ans What are the PDP and the alternate PDP? 1.72K viewsFood Safety 0 Votes 1 Ans Must the updated Nutrition or Supplement Facts label appear on all foods sold by July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales)? 1.43K viewsFood Safety 0 Votes 1 Ans When determining whether labels need to be in compliance with the new requirements, should the determination as to whether my company has $10 million or more in annual food sales be based on domestic food sales or total food sales, including international sales, and how many years of sales should I consider? 1.62K viewsFood Safety 0 Votes 1 Ans Are there certain approved companies or nutrition databases manufacturers can use to get their nutrition values for their products? 1.42K viewsFood Safety 0 Votes 1 Ans Who is responsible for the accuracy of the Nutrition Facts label on a food product’s label? Who is responsible for maintaining the records needed to verify the accuracy of certain nutrient declarations? 1.44K viewsFood Safety 0 Votes 1 Ans How will FDA exercise enforcement discretion with respect to mandatory and dual column nutrition labeling for bottled water products and coffee beans (whole or ground), tea leaves, plain unsweetened coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors that would have been exempt under § 101.9(j)(4) prior to the effective date of the Nutrition Facts label final rule? 1.56K viewsFood Safety 0 Votes 1 Ans Do sugars found in fruits and vegetables that have been processed to change the form of the fruit or vegetable (e.g., concentrated fruit and vegetable purees, fruit and vegetable pastes, and fruit and vegetable powders) need to be declared as added sugars on the label? 1.30K viewsFood Safety 0 Votes 1 Ans How should I calculate the amount of added sugars in a fruit juice blend containing the juices of multiple fruits that have not been reconstituted to 100 percent (full-strength)? 1.54K viewsFood Safety 0 Votes 1 Ans Can I use Brix values to calculate the added sugars declaration for a product containing fruit juice concentrates? 1.62K viewsFood Safety 0 Votes 1 Ans I add 100% fruit juice to my product, but water is removed from the product during processing. Therefore, the fruit juice is concentrated during processing of my product. How do I determine the amount of added sugars in the finished product? 1.61K viewsFood Safety 0 Votes 1 Ans The definition of added sugars excludes the “fruit component of fruit spreads.” What constitutes the “fruit component” of a non-standardized fruit spread? 1.48K viewsFood Safety 0 Votes 1 Ans The regulation says in 21 CFR 101.9(c)(6)(iii) that added sugars are a “statement of the number of grams of added sugars in a serving, except that label declaration of added sugars content is not required for products that contain less than 1 gram of added sugars in a serving if no claims are made about sweeteners, sugars, added sugars, or sugar alcohol content.” What does FDA consider to be a “sweetener?” Do sweeteners include sugar alcohols and other low-calorie sweeteners? 1.69K viewsFood Safety 0 Votes 1 Ans Some ingredients contain mono- and disaccharides (DP1 and DP2 (one and two degrees of polymerization)) that are created through processes such as hydrolysis. Do the mono and disaccharide portions of ingredients that are created through hydrolysis need to be declared as added sugars on the label? 1.38K viewsFood Safety 0 Votes 1 Ans If sugars are added to a food that already contains inherent sugars (e.g. to cranberries, tart cherries, or yogurt), does that make “added sugars” a Class I nutrient for purposes of compliance under 21 CFR 101.9(g)? If so, does that mean that the composite must be formulated to be at least equal to the value for the added nutrient (added sugars) declared on the label per 21 CFR 101.9(g)(4)(i), or is 21 CFR 101.9(g)(5) allowing up to 20% in excess of the value declared applicable? 1.55K viewsFood Safety 0 Votes 1 Ans What is the New FDA Rule? 1.18K viewsFDA « Previous 1 2 … 204 205 206 207 208 … 283 284 Next » Question and answer is powered by anspress.net
