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66 FR 65978 Draft Guidance for Industry Exemptions Gpo Form
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People also ask
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Can you sell food products without FDA approval?
Manufacturer of Food, Drug, and Medical device requires US FDA registration for their facilities. US FDA Registration is only needed if you are planning to market your products in the USA.
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Does juice have to be FDA approved?
Retail establishments or businesses that make and sell juice directly to consumers and do not sell or distribute juice to other businesses are exempt from the juice HACCP regulation, but must comply with FDA's food labeling regulation in 21 CFR 101.17(g) that requires a warning statement on packaged fruit and vegetable ...
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What foods need FDA approval?
Foods regulated by the Food and Drug Administration (FDA) generally include: Food products (other than meat, poultry, and egg products as regulated by the United States Department of Agriculture), such as: Dairy, produce, spices, nuts, cereals, flour, legumes, fruit & vegetable juices, vegetarian entrees, etc.
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What is the FDA limit for patulin?
Exposure over time to high levels of patulin may pose a health hazard. FDA has established an action level(4) for patulin in apple juice of 50 micrograms per kilogram (50 parts per billion) as determined on single strength apple juice or reconstituted single strength apple juice.
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Do I need FDA approval to sell juice?
All Juice processors in California must obtain a Processed Food Registration (PFR) from California Department of Public Health, Food and Drug Branch.
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What are the requirements for a juice label?
Beverages made from 100 percent fruit juice can say juice. However, if it has less than 100 percent, the label must include a qualifying term, such as a drink, cocktail, or beverage. If it's made from concentrate it must state that or include the word reconstituted.
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What is a 5 log pathogen reduction?
A 5-log reduction means inactivating 99.999% of a microbe or colony forming units (which is a measure of viable bacterial or fungal numbers or counts, also known as CFUs). This is calculated using a logarithmic scale, which stands for a 10-fold (or one decimal place) reduction in CFUs.
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What are the requirements for a juice label?
Beverages made from 100 percent fruit juice can say juice. However, if it has less than 100 percent, the label must include a qualifying term, such as a drink, cocktail, or beverage. If it's made from concentrate it must state that or include the word reconstituted.
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