Regulatory Guidance

Bioterrorism Preparedness Assistance

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires registration for all foreign and domestic facilities which provide the service of manufacturing, packing, and/or storing of food products for the consumption of both human and animal in the United States. R. Donnelly and Associates, Inc. has thoroughly reviewed all the requirements and can assist you in the registration process, as well as the requirement for all foreign establishments to have a U.S. Agent.

Label Claim Reviews

	Structure Function Claims
	Packaging Requirements
	Mandatory Disclaimer Statements
	Implied Claims

Advertising Guidance for Dietary Supplements

	Consumer Testimonials
	DSHEA Disclaimer
	Amount of Evidence Required for Support of Claims
	FTC Regulations
	Clear and Prominent Disclaimer

Nutritional Labeling of Food and Supplements

	Information Required
	Determine RDI (Reference Daily Intake)
	“Nutritional Facts” Requirements
	“Supplement Facts” Requirements

GMP Consulting Services

RDA’s consulting services can provide assistance in complying with the FDA’s new proposed Good Manufacturing Practices that will be finalized in the near future. These new regulations will govern the operations, controls, and labeling utilized in the manufacture of dietary supplements and dietary ingredients. We are currently in the process of assisting firms in determining the best way to comply with the new regulations affecting the dietary supplement industry. The best plan for your future is to develop a road map to guide you to compliance. The path chosen in the early stages of this journey will determine your destiny when the FDA eventually knocks on your door for an inspection. The process usually begins with an assessment of the firms operations with regards to the new proposed GMP’s. A detailed report is generated, which also includes recommendations toward achieving compliance. 

RDA can assist in Determining the GMP Requirements for Your:
 

Facility Sanitation Design Construction Equipment Mechanical Automatic Electronic Qualification Holding and Distribution In-process Materials Reserve Samples Returned Goods Distributing Dietary Supplements or Dietary Ingredients Consumer Complaints Qualified Reviews Investigations Written Records Follow-Up Actions

Production and Process Master Batch Record Development Specification Development  (Raw Materials and Finished Products) In-Process Testing Packaging and Labeling Quality Control Batch Production Records Laboratory Operations Rejected Components, Ingredients, and Supplements Calibration Cleaning Record Keeping SOP Development Training Records Certificate of Analysis Maintenance Logs Batch Records QC Testing Support Documents Electronic Records

Labeling and Promotional Material Reviews

RDA performs reviews of labeling and promotional materials against the current regulations to determine if any of the content may put products in jeopardy with the FDA. Applicable regulations are cited to provide a basis of support should the FDA ever challenge your labeling.

Dietary supplements are permitted to make structure function claims, but not disease claims. Any claims must be truthful, not misleading and substantiated.