Download
1 / 135
1.63k likes | 2.23k Vues
FDA Regulatory Requirements & The Food Safety Modernization Act. Presented by Anna Benevente , Senior Regulatory Specialist Registrar Corp October 2012. Seminar Overview. FDA: Background & Jurisdiction U.S. Agencies Regulating Food Products Key Food Regulations
E N D
FDA Regulatory Requirements &The Food Safety Modernization Act Presented by Anna Benevente, Senior Regulatory Specialist Registrar Corp October 2012
Seminar Overview • FDA: Background & Jurisdiction • U.S. Agencies Regulating Food Products • Key Food Regulations • FDA Food Safety Modernization Act (FSMA) • FSMA Requirements Currently in Effect • FSMA and Inspections • Detentions
U.S. Regulation Overview • The Constitution authorizes Congress to pass laws, which are then signed by the President. • Acts of Congress, e.g. Food, Drug and Cosmetic Act, are codified in the “United States Code,” which is cited as “U.S.C.” • The executive departments and agencies like FDA may promulgate “regulations.” • Regulations are promulgated through a lengthy process called "Notice and Commentary," to satisfy the requirements of the Due Process Clause of the U.S. Constitution.
U.S. Regulation Overview • Proposed regulations, notices, public commentaries, agency responses to the commentaries, and eventually the final regulations are published in the “Federal Register” as they occur. • Final regulations are codified in the “Code of Federal Regulations” (C.F.R.). • Guidance Documents are non-binding recommendations that contain U.S. FDA’s current thinking about a subject.
Code of Federal Regulations • The Food, Drug, and Cosmetic Act is detailed in what we call the “CFR” or Code of Federal Regulations. • The CFR is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. • Title 21 of the CFR is reserved for rules of the Food and Drug Administration.
Food, Drug, and Cosmetic Act (FDCA) • President Franklin Delano Roosevelt signed into law the Food, Drug, Cosmetic Act in 1938. • That law remains today the principal law regulating all food, beverages, drugs, cosmetics and medical devices in the USA.
FDA Regulates: • Food, Beverages, Health Supplements • Cosmetics • Veterinary Drugs • Medical Devices • Radiation-Emitting Products • Drugs: OTC, API, Prescription • Biologics: blood, tissues, vaccines • Tobacco
Dual Role of FDA FDA really plays two roles: • Gatekeeper: licensing body that decides what drugs, medical devices, food additives, etc, are appropriate for the marketplace. They set product standards, often with public & industry input. • Police: enforcer of regulations. They issue “Warning Letters,” work with CBP on seizures, and with the DOJ on criminal prosecutions.
Food, Beverages, & Supplements Center for Food Safety and Applied Nutrition (FDA) • Jurisdiction encompasses most food products (other than meat and poultry) • Agricultural products, processed food, canned foods, seafood, alcoholic and non-alcoholic beverages (including bottled water), seafood, etc
Other Agencies Regulating Food • U.S. Department of Agriculture • Food Safety and Inspection Service (FSIS) • Animal and Plant Health Inspection Service (APHIS) • National Organic Program • Department of Justice • Alcohol and Tobacco Tax and Trade Bureau (TTB) • Department of Homeland Security • U.S. Customs and Border Protection (CBP)
USDA/FDA Overlap USDA and FDA often both regulate a product: • If you grow and pack fresh fruit and vegetables for export, you fall under FDA and USDA; • USDA, along with FDA, controls for pesticide residues. • If you produce canned juice from the fruit, you fall under FDA alone; • Facility Registration, LACF regulations, etc. • Products with 3% or more raw meat or 2% or more cooked meat or 30% or more fat, tallow or meat extract regulated by USDA • Products containing 2% or more cooked poultry; more than 10% cooked poultry skins, giblets, fat and poultry meat in combination regulated by USDA
Department of Homeland Security: Customs and Border Patrol (CBP) CBP is responsible for enforcing import and export laws in our approximately 317 official ports of entry.
What is FDA’s Entry Role? • If FDA-regulated product, FDA is notified via the entry system. • U.S. FDA will then: 1. Release the product for entry 2. Further review the entry 3. Physically inspect the shipment 4. Refuse entry of the shipment
FDA Review of Entry What U.S. FDA does depends largely on: • The history of the country, the manufacturer, and the importer (have they had other violations?) • The product category: drug, food, medical device, or cosmetic? (risk level) • Nature of the product: fresh juice, fresh seafood, canned fruit? (risk level)
PREDICT • PREDICT = Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting • Risk-based screening system that quantifies the risk of imported food shipments • First tested for seafood products in the port of Los Angeles in 2007 • Pilot program was generally considered a success • Since been expanded
PREDICT • PREDICT establishes a risk score by analyzing importer’s shipment information using sets of FDA-developed risk criteria. • Risk criteria include: • Violative histories of the product, importer, manufacturer, consignee, and country of origin; • Results of laboratory analysis and foreign facility inspections; and • General intelligence on recent world events that may affect the quality of a particular food.
A Complex Web • The U.S. food agencies have over the years become a complex web, making it very confusing for foreign exporters, and even for U.S. companies. • Each agency has their own jurisdiction, and their own set of regulations to enforce. • And in the end, a balance between industry self-regulating (if you sell me bad product…) and government enforcement.
Requirements • Food, Drug, and Cosmetic Act • Bioterrorism Act • Registration, U.S. Agent, Prior Notice • Labeling • Formats, language • LACF – Low Acid Canned Food • HACCP – Hazard Analysis and Critical Control Point • GMP – Good Manufacturing Practices
Bioterrorism Act of 2002 • The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 • Effective starting in October 2003 • Who, What, Where, When, and How • Requires companies to register • Requires designation of a U.S. Agent for foreign companies for FDA communications • Require companies to file Prior Notice
United States Agent • Foreign Establishments must notify FDA of the name, business name, address, phone number, and email address of their United States Agent. The US Agent must reside or maintain a place of business in the US.
United States Agent • U.S. Agents have been designated since 2003, and foreign companies have not had to update that information since the initial designation • Since 2003, many customs brokers and importers have allowed foreign companies to designate them as the required “U.S. Agent”
Registration (Section 305) • Can’t register suppliers…they need to register on their own • Can’t “share” numbers… each factory or storage location has its’ own number • Technically the law does not require exporters, brokers, traders, or transporters to register, but many do simply to have their own number
Prior Notice (Section 307) • Must notify FDA before shipments arrive in U.S. instead of after arrival • Allows FDA to better target imports before they arrive in a U.S. port
Food Labeling & Ingredients Strict regulations concerning: • Formatting (font size, etc.) • Specific Required Declarations (Manufacturer, Net Quantity, Statement of Identity, Ingredients) • Nutrition Fact Charts • Supplement Facts Charts • Permitted Ingredients • Health Claims Standardization = Comparison
Principal Display Panel (PDP) • The Principal Display Panel (PDP) is the primary side of the label that the consumer will view --- this is usually the front of the package • Two required elements • Statement of Identity (common or usual name of food) • Net Quantity Declaration
Information Panel (IP) • The Information Panel (IP) is the label panel immediately to the right of the PDP • Three required elements • Nutrition Facts/Supplement Facts Chart • Ingredients List • Manufacturer Identity • Must be presented with no intervening information
Examples of Other Formats STRICT rules govern when each can be used
Examples of Other Formats Use dictated by the package configuration and type of dietary ingredients found in the product
Serving Sizes • The serving sizes that appear on food labels are based on FDA-established lists of "Reference Amounts Customarily Consumed Per Eating Occasion." • The reference amounts, which are part of FDA regulations, are broken down into 139 FDA-regulated food product categories (e.g., “cookies 30g”) • Dietary supplements must use the “the maximum amount recommended… per eating occasion.”
Ingredients List • Must appear with the Nutrition Facts or Supplement Facts Chart, no intervening information • Ingredients must be listed in descending order of predominance by weight by common/usual name(no “E” designations or trade names) • Must be at least 1/16 of an inch • Specific requirements for the listing of colors
Manufacturer/Distributor/Packer Identity • Must give actual corporate name • Must appear with Chart and Ingredients, no intervening information • If not the actual manufacturer, company name must have a qualifying phrase that states the relation to the product, e.g., "manufactured for" or “distributed by”. • Must be at least 1/16 of an inch • Requires the firm name, street address, city or town, country, and a postal code • Street address not required if found in a local directory
Country of Origin • The Tariff Act of 1930 requires that the country of origin statement be placed on the label in a conspicuous location. • If a domestic firm's name and address is declared as the firm responsible for distributing the product, then the country of origin statement must appear in close proximity to the name and address and be at least comparable in size of lettering. • “Product of Mexico” or “Made in Mexico”
Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) • FDA estimates that: • Approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies; and • Each year, roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food; • Eight major foods or food groups--milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans-- account for 90 percent of food allergies
FALCPA • If your product contains ingredients that are any of the allergens specified by FALCPA, they must be declared either immediately after the ingredients list in a statement that reads, “Contains Wheat, Eggs…” or in the ingredients list by listing the source allergen of the ingredient in its common name, e.g. “Flour (from wheat).” • FDA is currently considering comments related to “advisory labeling” such as “produced on machinery that also processes [allergen]”
Bilingual Labeling • All labels must be in English • Common reason for detention • If the label, boxes, or inserts contain any representations or declarations in a foreign language, then all required statements must also appear in that language on that particular label (excluding mottos) • You may choose to include: • Two Nutrition Facts charts, or • A bilingual Nutrition Facts chart.
Product Claims • Nutrient Content Claims • “high in calcium,” “good source of vitamin C” • Relative Claims • “light sour cream,” “reduced sodium potato chips” • Structure/Function Claims • “calcium supports bone strength,” “fiber maintains regularity” • Health Claims • Specifically reference disease, must be approved by FDA: • Ex. “Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.” Must meet FDA definition for “low fat”
Product Claims • Unapproved new drug or dietary supplement? • Exporters of dietary supplements often encounter claim-related detentions • Does it “cure cancer” or • Does it “support immunity”
Correcting Existing Labels • Correcting label mistakes in any manner may be acceptable if the final label is correct and complies with all regulations at the time of retail sale. • Stickers should not cover other mandatory labeling, and should adhere tightly. • Be sure to follow stringent Nutrition Facts Chart/ Supplement Facts Chart formatting guidelines.
Common Misconceptions • There is no “licensing” or “approval” process for labels (except for meat & poultry and alcoholic beverages) • Common mistake – copying other wrong labels • Just because it is approved for use in the EU does not mean that it is permitted in the US • Bar codes, lot numbers, and expiration dates on food are not regulated by FDA • Labeling compliance does not mean just the label affixed to product – applies to websites, brochures, advertising, etc.
Common Misconceptions • Use of the “®” for a Trademark • In order to use the registered trademark symbol “®”on your labeling, your product must be a registered trademark in the U.S. U.S. Customs and Border Protectiono may seize any goods which violate this rule and subject the violator to penalties. • "TM" is used for marks that are not yet registered in the U.S. Patent and Trademark office and puts the public on notice of your claim of ownership.
