Label Compliance
Labels and labeling are crucial for product marketing as well as compliance with government regulations. In addition to FDA labeling regulations, foods, drugs and consumer health products are also subject to Federal Trade Commission (FTC) and Consumer Product Safety Commission (CPSC) labeling regulations. Some may even be affected by Environmental Protection Agency (EPA) regulations. Four basic elements are required on all consumer product labels:
- Statement of identity
- Net quantity of contents statement
- Ingredient or contents statement
- Signature line listing name and physical address of the US manufacturer, packer or distributor
Food, supplement, cosmetic, homeopathic and drug labels have a number of other required elements that must appear on the label so that the product may be lawfully distributed. Some marketing claims are permitted, others are not. Improperly labeled products may be deemed misbranded or adulterated and subject to regulatory agency action. Avoid receiving an FDA warning letter or cyber letter and other costly labeling errors by ensuring that your labels are compliant with FDA & FTC regulations. Let Bioscience Translation & Application™ help you with all your labeling needs.
Commonly requested services include:
Label Evaluations for FDA (or USDA) and FTC Compliance
We will review dietary supplement, food (including FDA-regulated alcoholic beverages), cosmetic, homeopathic or over-the-counter drug product label prototypes for compliance with FDA or USDA and FTC regulations.
This service includes a detailed report providing guidelines for any needed changes and a preprint review of the revised label. Regulatory compliance is guaranteed.
Fee is $700 for most labels. Additional charges apply to products with extensive facts box listings or marketing text. [Client provides a copy of the prototype label for review along with dimensions of actual label.]
Supplement Facts or Nutrition Facts Boxes
Send us your formulation and we will provide you with an electronic image you can put into your food, supplement or menu layout. Multiple facts box formats are available to ensure compliance for small and intermediate size packaging. English, Spanish and bilingual formats are also available.
You may also have your existing facts box checked for accuracy. Facts box services start at $150. [Client provides formulation as well as certificates of analysis in addition to submitting prototype label and dimensions. All information is kept strictly confidential.]
Label Mock-up (Sketch) and FDA/FTC Compliance Evaluation
If you are unsure how a product label should be laid out, let us prepare a label mock-up (sketch) including Facts box, ingredient statement and FDA- or USDA-required label components. The sketch will be based on your formulation and proposed label claims for dietary supplement, food, homeopathic, cosmetic or over-the-counter drug products. This service also includes review of claims for FTC compliance as well as comprehensive preprint check of finalized label. Regulatory compliance is guaranteed.
Fees for this service vary depending upon the type of product and the number of ingredients. Send us your product information including name and ingredient list and we will provide a quotation. [Client provides a complete formulation, specification sheets, certificates of analysis, intended dosage, any label text or marketing information and proposed label dimensions.]
FDA & FTC Compliance Reviews for Promotional Copy
Are your label claims allowable? Do you have adequate substantiation for your claims? Let Bioscience Translation & Application™ review your promotion materials, including catalogs, brochures, websites, third-party literature, advertisements, audiotape scripts, etc. for compliance with applicable regulations. A report outlining any needed changed will be provided. Prices quoted per project. [Client provides copy of the intended promotional copy.]
Other labeling and regulatory affairs services are available contact us regarding your project needs.
Advanced payment is required. Projects are completed within 10 business days of receipt of payment and information required for project completion. Five day service is available for a 50% premium on the fee. Completion within 72 hours is provided for a 100% premium on the fee as our schedule permits.
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