Does my product require FDA approval? FDA Pre-Approval Requirements
How can you tell if your product needs pre-approval from the FDA before you can market it to the public?
This blog gives you a general idea of the types of products and additives that require pre-approval from the FDA prior to marketing (going to market). You’ll need to consult the FDA and visit the FDA’s website to confirm current information, as this blog is not intended nor should be construed as any form of FDA approval advice.
It may be helpful, however, in providing a brief and general overview in relation to which products require FDA pre-approval before marketing to the public (and which products fall under FDA’s regulatory authority and may be subject to GMP compliance audits).
NB: These lists are not fully inclusive but will give you a general overview of which products needs FDA pre-approval prior to marketing to the public. This should not be taken as advice and you need to consult the FDA’s websites for details and confirmation.
For details and updates on approvals from the FDA, visit the FDA website pages.
Be sure you have the appropriate understandings of GMP requirements (online GMP courses/GMP training requirements) as there are legal and criminal liabilities for selling certain products that either do not meet standards, are fraudulent or misrepresented, and/or cause public harms.
FDA Approvals and Product Safety including Recalls and Bans
As you go about your manufacturing investigations, recognise that you have liability as an individual and company/organisation for the products you are marketing to the public. Many products will fall under the FDA’s authority and regulatory powers, even if they are products that do not require pre-approval before marketing.
FDA GMP Audits
The FDA, like the TGA, has the primary aim of public safety and protection, ensuring certain foods, medicines and medical devices have demonstrated safety and efficacy, including being safe from contaminants and produced according to international quality standards (GMP and PICS being two examples).
Inspections that discover serious breaches in terms of GMP compliance, defects and/or false product labeling, can result in jail terms for pharmaceutical and medical device manufacturers and employees working in regulated industries having the potential to lead to health harms and/or fatalities.
Pre-Approval by FDA vs Approval Not Required | Regulatory Authority Powers in terms of GMP compliance failures (FDA Audits)
While not all products require pre-approval by the FDA, the FDA still has regulatory authority in the event of public safety concerns.
- The FDA has regulatory authority in the event of a public safety issue related to your product.
- This means they have the right to inspect your production facilities and processes including your quality management systems (QMS), source suppliers and distribution processes and vendors
- The FDA can demand a recall and/or other corrective actions as well as instigate criminal charges in the event of public harms, fraudulent product claims, fake pharmaceutical products and/or contaminated medications or tampered products.
If your product causes harm, you could face criminal charges and prison sentences (examples of criminal cases relating to FDA regulated products are listed below):
- producer of counterfeit medicine products sentenced to prison (USA)
- prison for CEO of a company producing misbranded pharmaceuticals/drugs
- printer/label maker of counterfeit animal medications/animal drug labels sentenced to prison
- FDA prosecution related to illegal silicone injections (illegal cosmetic injections)
- FDA prosecutions related to drug tampering
Does my product require FDA approval? Snapshot of products governed by the FDA (Food and Drug Administration).
Below is a non-inclusive list of types of products that are regulated by the FDA / USA federal government.
This means that the FDA has jurisdiction and power to inspect/audit and enforce safety measures for these products/goods; including enforcing recalls and — where harm, fraud and/or other misrepresentation has occurred — initiating criminal charges that could lead to jail time for involved parties.
- Pharmaceuticals (medications)
- Medical devices
- Medical biologics
- Human food
- Animal feed/animal food
- Products containing tobacco
- Electronic products that emit radiation (cellular phones, for example)
Products requiring FDA approval prior to being marketed (FDA’s premarket approval requirements):
- Drugs and biologics
- need to be tested/proven safe and effective
- product’s benefits must outweigh risks related to intended use
- New ADDITIVES to animal drugs and animal foods
- pet foods
- poultry feed
- livestock foods/feed
- Medical devices
- risk classifications can vary from Class I (least regulation) to Class II (requires clearance prior to marketing) to Class III devices (such as implants or life-sustaining devices, which requires pre-marketing approval by the FDA)
- Human tissues and cells (blood, bone and tissue products)
- examples: transplanted products
- corneas, skin, bone and tissue products that can transmit infectious diseases
- must be preapproved prior to marketing if blood, bone and tissue products pose risks other than disease transmission
- Food ingredients and additives
- preservatives, texturizes and additives must be safety tested
- includes packaging that can come into contact with the food (plastic wrap, etc)
- including new additives not yet approved (e.g. unapproved additives in supplements/vitamins or foods)
- Color additives and other additives
- such as added to drugs, foods and cosmetics
- new additives aimed to be used in dietary supplements, medications or foods
Notification to FDA in advance of production (special requirements/notifications/registrations) are also required before producing/marketing:
- Dietary supplements containing new dietary ingredients
- Infant formula
- Must be registered with FDA
- Must meet nutritional standards
- New Tobacco Products
- must comply with FDA requirements
- require a written order from the FDA that the product DOES comply with requirements
Products for which FDA pre-approval NOT required
Which products do not need FDA approval before marketing/distribution?
While these products fall under the FDA’s regulatory authority, and are subject to FDA inspections / GMP audits, they do not typically require pre-release approval by the FDA. However, you should verify this with current FDA information about FDA approvals.
All products that fall under the FDA’s jurisdiction, even if they do not need pre-approval before marketing, must meet specific GMP requirements and/or may need to be registered for tracking and recall purposes.
The FDA also has jurisdiction and authority over these products in the event of safety issues/complaints and adverse effects or other harms, or breaches of required GMP standards such as manufacturing sterility/product safety and testing/validation, secure packaging and more.
Subjected to audits and FDA regulations but not always needing pre-approval, so long as meets pre-designated safety standards/GMP:
- New food products which do not contain new additives / new food sources
- Compounded drugs
- Infant formulas (must meet nutritional requirements/be registered)
- Food labels (however, food labels must include the Nutrition Facts panel per FDA regulations).
You can visit the FDA website for a more in-depth guide to regulated products.
References / Sources and Further Information
Basic GMP information and Training
Help with FDA Audit Responses and/or other country GMP or EU GMP Audits
Contact PharmOut’s industry experts GMP Audit response consultants.