Imagine living in the 19th century. It was an age of industry, experimentation, and scientific discovery. Some advancements, however, were not always in the best interests of public health and safety. According to a federal government history site, the United States government began using chemical analysis to monitor the safety of food products as early as 1848.
The passing of the Pure Food and Drugs Act in 1906, gave the federal government regulatory power to protect the public from misbranded or adulterated food and drugs. The regulatory body in charge became officially known as the US Food and Drug Administration in 1930.
Who or What Establishment Requires Registration with the FDA?
As time, technology, and situations have evolved, so have the responsibilities of the FDA. The official FDA website contains a list of regulated products. If a facility or establishment is involved in any way, be it manufacturing, processing, packing, re-packing, labeling, storing, or distributing the following products, it must be registered with the FDA.
- Medical Devices
- Radiation Emitting Products
- Vaccines, Blood, and Biologics
- Animal and Veterinary (Food and Drugs)
- Tobacco Products
CTLA Meets FDA Regulatory Requirements
Detailed and rigorous testing requirements have been set by the FDA to protect public health. Food, animal food, drugs, animal drugs, dietary supplements, and cosmetics must be regularly tested to avoid harming individuals and animals from microorganisms, heavy metals, or allergens.
CTLA is an FDA-registered laboratory. We offer full-service safety and identity testing for food, dietary supplements, and cosmetic products. In addition, CTLA performs testing for manufacturers with third-party Good Manufacturing Practices (GMP) Certification.
ISO/IEC 17025:2017 Accreditation
You can trust our dedication to accurate and reliable laboratory testing. To prove our commitment to excellence, CTLA has obtained ISO/IEC 17025:2017 Accreditation.
With this accreditation, CTLA’s services can help you meet the new Amazon certificate of analysis (CoA) requirements for products requiring a supplement’s fact panel. We have in-house procedures streamlined to meet Amazon’s required testing and documentation processes. Put our experience to work for you to market your brand’s supplements on Amazon.
Regardless of the size of your company, CTLA is devoted to excellent customer service. We pride ourselves on clear, timely communication and quick turnaround times.
Register Your Facility with the FDA
Connecting to the official FDA website is the best way to start your regulated facility’s registration process. To facilitate sharing sensitive information electronically to the FDA and obtain electronic certificates, the FDA has established an Electronic Submission Gateway (ESG). The ESG http site is secure and ensures information is encrypted and transmitted securely.
For official US FDA regulatory updates and procedures, check the appropriate associated sites. Federal government websites often end in .gov. You can find information to contact the FDA on its website. Skip to the footer links listed at the bottom of any FDA page to find additional information pertinent to your facility and/or products.
You can use various social media outlets including Facebook to follow FDA announcements and actions. Or subscribe to FDA RSS feeds for FDA videos on YouTube or Twitter to view the latest public health concerns and FDA actions.
The content of CTLA’s website is for information only, not advice or guarantee of outcome. Information is gathered and shared from reputable sources; however, CTLA is not responsible for errors or omissions in reporting or explanation. CTLA gives no assurance or warranty regarding the accuracy, timeliness or applicability of the content.
Sources“Subscribe to Podcasts and News Feeds.” Food and Drug Administration. 2021. https://www.fda.gov/about-fda/contact-fda/subscribe-podcasts-and-news-feeds
“FDA History.” Food and Drug Administration. 2018. https://www.fda.gov/about-fda/fda-history
“ESG Appendix C: Digital Certificates.” Food and Drug Administration. 2020. https://www.fda.gov/industry/about-esg/esg-appendix-c-digital-certificates