The U.S. Food and Drug Administration (FDA) regulates cosmetics under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The
FDA’s primary responsibility is to ensure that cosmetics are safe for use and properly labeled.
Cosmetic manufacturers are not required to obtain FDA approval before selling their products,
but they are responsible for ensuring that their products are safe for use and that their labels are
truthful and not misleading. The FDA can take action against cosmetic manufacturers if their
products are found to be unsafe or if their labeling is false or misleading.
The FDA has established guidelines for cosmetic labeling, including requirements for the
declaration of ingredients, warnings about potential allergic reactions, and other information.
The FDA also has the authority to inspect cosmetic manufacturing facilities to ensure
compliance with Good Manufacturing Practices (GMPs) and other regulations.
Cosmetics are not required by law to be approved by the FDA before they are sent to the
market but there are laws and regulations that apply to cosmetic products sold in the United
States and the FDA can perform inspections of cosmetic facilities and take action against those
facilities that do not comply with those outlined laws and regulations.
Overview of Cosmetic Services
· Cosmetic Labeling and Claims
· Cosmetic Good Manufacturing Practice Audits
· 483 Warning Letter and Remediation
· Recalls and Market Withdrawals
· Due Diligence Audits
Food and Dietary Supplements
The FDA is responsible for regulating and overseeing the safety and labeling of food products,
including dietary supplements, sold in the United States. Here is a summary of the FDA’s
oversight of food and dietary supplements:
1. Safety: The FDA has the authority to take action against any food or dietary
supplement that is deemed unsafe, including issuing recalls, seizing products, and
prosecuting companies that violate safety regulations.
2. Labeling: The FDA requires that all food and dietary supplement labels accurately
reflect the contents of the product, including its ingredients, nutrition information,
and any health claims. The FDA also prohibits false or misleading claims on
product labels.
3. New Dietary Ingredient Notification: Dietary supplements containing a new dietary
ingredient (an ingredient not previously used in dietary supplements) must undergo
a pre-market safety evaluation by the FDA, and the manufacturer must notify the
FDA of their intent to market the product.
4. Good Manufacturing Practices: The FDA enforces Good Manufacturing Practices
(GMPs) for dietary supplement manufacturers, which establish minimum standards
for the production, packaging, labeling, and storage of dietary supplements.
5. Adverse Event Reporting: The FDA requires dietary supplement manufacturers to
report any adverse events associated with their products, including serious
adverse events, to the FDA within 15 business days of becoming aware of the
event.
Overall, the FDA’s oversight of food and dietary supplements is intended to protect public health
by ensuring that these products are safe, accurately labeled, and manufactured in accordance
with established standards.
Overview of Food and Dietary Supplement Services
· Labeling and Claims Review/Guidance
· Good Manufacturing Practice Audits
· FDA Mock Audits
· New Ingredient Notification Support
· 483 Warning Letter and Remediation
· Recalls and Market Withdrawals
· Due Diligence Audits
· Adverse Event Reporting Program development
Drugs
The FDA is responsible for regulating the approval of drugs, including prescription medications
and over-the-counter (OTC) products. The FDA’s drug approval process involves several stages
of evaluation to ensure the safety, efficacy, and quality of drugs before they can be marketed
and sold to the public.
Clinical trials involve testing the drug on human subjects to determine its safety, efficacy, and
optimal dosage. Clinical trials are conducted in three phases, and each phase involves
progressively larger groups of human subjects. Phase 1 trials typically involve a small number of
healthy volunteers, while phase 2 trials involve a larger number of patients with the condition the
drug is intended to treat. Phase 3 trials involve an even larger group of patients and are
designed to confirm the drug’s efficacy and safety in a real-world setting.
Once a drug has successfully completed clinical trials, the drug manufacturer submits a New
Drug Application (NDA) to the FDA. The NDA contains all the data gathered during the drug
development process, including preclinical and clinical trial results. The FDA then reviews the
NDA and decides whether to approve the drug.
If the drug is approved, it can be marketed and sold in the United States. However, the FDA
continues to monitor the safety and effectiveness of drugs even after they have been approved
and can take action to remove drugs from the market if safety concerns arise.
Overview of Drug Services
• OTC Labeling and Claims
• Support for clinical trials, including Quality Oversight
• Support for filing NDA’s
• FDA Mock Audits/Pre-Approval Inspection (PAI) Readiness Audits
• 483 Warning Letter and Remediation
• Recalls and Market Withdrawals
• Data Integrity Audits
• Data Integrity Governance Program Development and Training
• Due Diligence Audits
• Post Marketing Surveillance Program Support
Medical Devices
The FDA is responsible for regulating the approval of medical devices, including diagnostic
tests, surgical instruments, implantable devices, and other medical technologies. The FDA’s
medical device approval process involves several stages of evaluation to ensure the safety and
efficacy of devices before they can be marketed and sold to the public.
The medical device approval process begins with the submission of a 510(k) or premarket
approval (PMA) application to the FDA. The 510(k) pathway is used for devices that are similar
to those already on the market, while the PMA pathway is used for more complex devices that
are higher risk.
Devices that go through the 510(k) pathway must demonstrate substantial equivalence to a
legally marketed device, while devices that go through the PMA pathway must undergo
extensive testing and clinical trials to demonstrate safety and effectiveness.
The FDA evaluates the device’s design, materials, intended use, and potential risks to
determine whether it meets regulatory standards. If the device meets these standards, it can be
cleared or approved for marketing in the United States.
Once a device has been approved, the manufacturer must continue to monitor its safety and
effectiveness through post-market surveillance and reporting of adverse events. The FDA can
take regulatory action to recall or remove devices from the market if safety concerns arise.
In addition, the FDA has established a new regulatory framework called the Breakthrough
Devices Program which is intended to provide a faster path to market for medical devices that
can provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating
diseases or conditions. This program offers additional support to medical device manufacturers
during the development and review process, with the goal of getting these devices to patients in
need more quickly.
Overview of Medical Device Services
• Support for filing 510(k) and/or PMA
• FDA Mock Audits/Pre-Approval Inspection (PAI) Readiness Audits
• 483 Warning Letter and Remediation
• Recalls and Market Withdrawals
• Data Integrity Audits
• Data Integrity Governance Program Development and Training
• Due Diligence Audits
With the passing of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the regulatory
environment for cosmetics in the US is quickly changing as GMPs regulations will be implemented along
with additional aspects such as product and facility registration, adverse event reporting, and
mandatory recall authority for FDA. Companies who export cosmetic products to China also have new
requirements to comply with given the Cosmetics Supervision and Administration Regulation (CSAR)
became effective in 2021. It has never been more important to have a knowledgeable and practical
partner to help guide your organization through these changes successfully.
News
- FDA Updates Its Classification of Certain Opthalmic Products: In March 2022, the FDA published
guidance on “Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4.”
This guidance was issued as a result of the court ruling in Genus Medical Technologies LLC v. U.S
Food and Drug Administration in April 2021, which focused on the FDA’s previous regulatory
authority as it relates to classifying products that meet both the definition of a drug and device
as a drug only, at the agency’s discretion. The FDA argued that the device definition was nested
within the more universal drug definition, but the court disagreed. The judge found that the
medical device definition was narrower, and therefore products that met the definition of a
device must be regulated as such even if they also met the definition of a drug. The court ruled
that any product that met the statutory definition of a device must be regulated as a device and
ordered the FDA to review and reclassify all products that met both definitions as devices
(where previously classified at the agency’s discretion).
Understanding the changes
Before this decision, ophthalmic dispensers packaged together with the associated ophthalmic
drug were regulated only as drugs, and not as a combination product as defined in the
regulations. These products were therefore not required to meet the requirements in 21 CFR
Part 4, which covers the “Regulation of Combination Products.” Though there are multiple
definitions for combination products used by the FDA, the one that applies to ophthalmic
dispensers would fall under the following: “Two or more separate products packaged together
in a single package or as a unit and comprised of drug and device products, device and biological
products, or biological and drug product.” In theory, ophthalmic dispensers packaged together
with the ophthalmic drug with which they were intended to be used have always met the
definition of a combination product, but the FDA is now classifying them as such because the
dispenser meets the definition of a device constituent part.
At this time, the FDA does not intend to take action on products that have previously not been
classified as a combination product until they have fully evaluated the application of 21 CFR Part
820 Quality System Regulations (Devices) on lower risk constituent parts. However, new product
applications will be expected to meet the requirements of 21 CFR Part 4. Dr. Jeffrey Shuren,
head of the FDA’s Center for Devices and Radiological Health (CDRH), was asked about the
impact of the Genus court decision on the FDA’s review of products and the associated
reclassification effort during his September 20, 2022 appearance at the Consumer Healthcare
Product Association’s Regulatory, Scientific and Quality Conference. He was also asked if
manufacturers would have any influence on whether or not their products are reclassified. Dr.
Shuren said that Congress is discussing this issue, and he hoped they would address it with
legislation changes. He also stated that manufacturers would not have any influence on their
product reclassification.
Who is impacted
Companies that have developed ophthalmic products under 21 CFR Part 211 Current Good
Manufacturing Practice for Finished Pharmaceuticals will now have to incorporate the required
elements of 21 CFR Part 820 to be compliant with regulations. This will require modifications to
the company’s overall quality management system.
What will this look like? Manufacturers who already meet all the cGMP requirements under 21
CFR Part 211 will now have to include the following elements from 21 CFR 820:
Section 820.20: Management Responsibility
Section 820.30: Design Controls
Section 820.50: Purchasing Controls
Section 820.100: Corrective and Preventive Action
Section 820.170: Installation
Section 820.200: Servicing
Implementation of these new requirements doesn’t have to be overly complex. For example:
A manufacturer using a streamlined approach following 21 CFR 211 with the required
additions of 21 CFR 820 will need to address Management Responsibility. Many drug
companies already use the Management Review process, which can be augmented to meet
the requirements of Management Responsibility.
A manufacturer using a streamlined approach following 21 CFR 211 with the required
additions of 21 CFR 820 will need to address Purchasing Controls. Supplier Qualification
processes can be augmented to add in the necessary provisions for Purchasing Control
rather than creating a completely separate SOP.
A manufacturer using a streamlined approach following 21 CFR 211 with the required
additions of 21 CFR 820 will need to address Corrective and Preventive Action (CAPA). Drug
investigation processes (21 CFR 211.192) can be augmented to add in the necessary
provisions for CAPA rather than creating a completely separate SOP. Keep in mind that
CAPAs for medical devices have a different approach than CAPAs for drugs, so create your
SOP accordingly.
Installation and Servicing would not typically need to be addressed for simple device
constituent parts such as manual dispensers used with ophthalmic products.
Drug companies may find themselves struggling with design controls and certain usability
factors such as the ability of the device to work under the defined drug delivery situation. Design
control processes for devices are a significant departure from drug development so drug
companies will need to have well-defined Combination Product Development and Combination
Product Risk Management procedures.
- Cosmetics Regulation Increasing: On December 29, 2022, President Biden signed into law the
“Modernization of Cosmetic Regulation Act of 2022” which requires increased FDA oversight of
cosmetics and the ingredients contained in cosmetic products. It is expected that changes to
how cosmetics are regulated will take place over the next year or more and the FDA will provide
guidance outlining the dates firms must show compliance to the new regulations. One
significant requirement in this act is that any firm that engage in the manufacturing or
processing of a cosmetic product for US distribution must register with the FDA and provide a
listing of each cosmetic product and the ingredients no later than December 29, 2023. In
addition to increased cGMP requirements that will be implemented, firms will be required to
maintain records to show adequate substantiation of safety of the cosmetic product.