Companies in the food and beverage industry work in an environment of complex regulation, thin margins and low barriers to entry for competitors. In addition, more consumers are paying closer attention to what they eat and how it is produced and prepared. In light of increased food recalls, there are rising concerns about food allergens and other food safety issues, which have increased regulation and regulatory enforcement. Many competitors respond by developing more highly value-added production lines, increasing capital demands, and requiring greater manufacturing sophistication for all companies. To succeed, companies need to execute efficiently, maintain careful and thorough regulatory compliance programs, and constantly innovate to maintain their position in the market.
Our firm provides a broad range of international legal and regulatory services related to the production and marketing of finished food, food ingredients, and food contact materials (including packaging materials).
Labeling Review:FDA regulations require that certain information appear on food and dietary supplement labels, such as statement of identity, net quantity of contents, and ingredient information. The information must also be formatted in accordance with the regulations. By law, companies may make three types of claims on their products: health claims,structure/function claims, and nutrient content claims. Different requirements generally apply to each type of claim. Unless specifically allowed by regulation, a company is prohibited from making labeling claims that imply its food products diagnose, cure, mitigate or prevent disease.
Our firm conducts label and ingredient reviews for all functional foods and dietary supplements in accordance with FDA regulations. This includes review of structure/function claim, health claims, and nutrient content claims, as well as the formatting of the labeling.
The firm also can help you file a 30-Day Structure/Function Claim Notification with the FDA for your dietary supplements.
Advertising Review: Our firm provides advertising counseling for your functional foods and dietary supplements to ensure conformance with regards to third-party testimonials and websites, social media, claim substantiation (amount of scientific support) and various other Federal Trade Commission (FTC) regulations.
Facility Registration and Prior Import Notice: The FDA requires facilities that manufacture, process, pack or store foods and dietary supplements marketed in the U.S. file registrations with FDA. Under theBioterrorism Act, foreign food and dietary supplement manufacturers must also register with the FDA and provide prior notice of import before their products arrive in the U.S. We can assist you with registration and filing Prior Import Notices and will work closely with your Customs broker to ensure compliance with the Bioterrorism Act and Prior Import Notice requirements.
Adverse Event Reporting & Record Keeping: Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a dietary supplement company whose name appears on the product label must report to the FDA certain adverse events associated with the product and maintain reports of adverse events. Our firm helps clients develop process and standard operating procedures (SOPs) for identifying and reporting adverse events, train monitoring staff on the process, and conduct audits to assess compliance.
Export Certificates: Struggling to determine whether you need a n Export Certificate to Foreign Governments, Certificate of Exportability, or Certificate of a Pharmaceutical Product? Not sure whether to use Form 3613a or 3613b? We can help you apply for the right export certificate for your device. Our firm offers the experience to make the process simple and straightforward, eliminating confusion on what forms and attachments to include. Whether your already selling the product in the US or only looking to export we can help.
Import Alerts: If the FDA customs detained your product an immediate response is required to avoid listing on an Import Alerts. Import Alerts are publicly published notices of violations that also allow the FDA to detain every shipment that enters the country. If you’ve already received an Import Alert, such as Import Alert 89-08, we can help petition the Agency for removal. Our firm offers experience working with clients from South Korea to Canada and Europe to petition the FDA for removal from an Import Alert.
Warning Letter & Border Detention Assistance: If you received a warning letter from the FDA, or if your products were detained at the border, you may be able to ask the FDA to allow you to “fix” a deficiency so that you wouldn’t have to destroy the products or ship them out of the country. However, you only have a short period of time to make the request, and you need to act fast. We can help you respond and take appropriate actions so you can get back to business. Contact the firm as soon as possible for a free initial consultation.
Our firm provide clients with a unified, one-stop solution to their legal needs. We advise clients regarding compliance with a variety of statutory and regulatory requirements, guidance documents, and informal policies, including those governing:
- Labeling and advertising claims, including triggered disclaimers
- Nutrient content claims
- Structure/function claims
- Health claims and qualified health claims
- Statements of nutritional support
- Third-party literature
- Cosmetics claims
- Miscellaneous descriptive claims (e.g., “organic,” “natural,” “fresh,” “pasteurized”)
- Labeling representations
- Statements of identity, including names specified by a statute, standard of identity, or established common or usual name
- Net contents declarations
- Nutrition information (e.g., Nutrition Facts, Supplement Facts), including format, display, and exemptions
- Ingredients listings, including incidental additives
- Major food allergen labeling
- Names and places of business of manufacturers, packers or distributors (a/k/a “signature line”)
- Country of origin markings and “Made in USA” representations
- Spices, natural and artificial flavors, colorings, and chemical preservatives
- Percent-juice declarations
- Warning, notice, and safe handling statements
- Irradiation disclosures
- Voluntary nutrition labeling at retail of raw fruit, vegetables, and fish
- Product formulation, manufacturing, and packaging
- GRAS (generally recognized as safe) ingredients, including GRAS self-affirmation
- Color additives and food additives, both direct and indirect
- Dietary ingredients, including new dietary ingredients
- Cosmetics ingredients
- Fortification policy
- Current good manufacturing practices (CGMPs)
- Hazard analysis and critical control point (HACCP) systems
- Tamper-resistant packaging
- Mandatory and voluntary submissions
- Nutrient content claim, health claim, and qualified health claim petitions
- FDAMA notifications for nutrient content claims and health claims
- Statement of nutritional support (structure/function claim) notifications and new dietary ingredient notifications for dietary supplements
- “Pasteurized” notifications
- Citizen petitions
- Temporary marketing permit applications
- New infant formula notifications and infant formula recall notifications
- Establishment registrations and process filings for acidified food and low-acid food in hermetically sealed containers
- GRAS notifications
- Food additive and color additive petitions
- Food contact substance notifications
- Notices for biotechnology products and bioengineered foods
- Bioterrorism Act
- Food facility registration, including acting as U.S. agent for foreign facilities
- Prior notice of food imports
- Recordkeeping and records access
- Administrative detention