Selling topicals?
THE NEW TIME-SENSITIVE REGULATORY
REQUIREMENTS YOU NEED TO KNOW
AND HOW TO GET HELP FAST

Maybe you're making and selling a new skin care or personal care line. Maybe you're selling a cannabis or CBD muscle rub. Regardless of what you're making or selling, you gotta get it registered with the FDA, under the new Modernization of Cosmetic Regulations Act (MoCRA).

FDA isn't just for OTC and pharmaceutical drugs anymore, they are now regulating cosmetics and other personal care items. If your company name or logo is on the products you are selling, you are required to comply, even if you're private labeling!

WHO SHOULD WATCH
  • Personal Care / Cosmetic Brands
  • Own Brand / Private Label Brands
  • Cannabis Brands
  • Product Lines with Structure / Function / Medical Claims (OTC)

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

"MoCRA is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily." - FDA
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Cosmetic Product Categories and Codes

MoCRA now requires product categories to be identified upon product registrations. See the list of cosmetic categories.
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Cosmetics Labeling Guide

"The Cosmetics Labeling Guide provides step-by-step help with cosmetic labeling, with examples and answers to questions manufacturers often ask about labeling requirements under U.S. laws and related regulations." - FDA
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Cosmetics Labeling (21 CFR Part 701)

FDA cosmetic labeling requirements.
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Cosmetic Product Warning Statements (21 CFR Part 740)

FDA cosmetic labeling requirements of warning statements.
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Structured Product Labeling Resources (SPL)

"The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information." - FDA
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Fact Sheet for Small & Home-Based Businesses

"Yes. FDA regulates cosmetics under the Federal Food, Drug and Cosmetic Act (FD&C Act). Under MoCRA, which expanded FDA’s authority under the FD&C Act law, cosmetics must not be adulterated or misbranded." - FDA
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Cosmetics Importers & Exporters: Fact Sheet

"Answers to common questions about FDA’s requirements for cosmetics. Notifications to FDA field staff, alerting them to imported products that may be refused admission without physically examining the products in a shipment." - FDA
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Color Additives and Cosmetics: Fact Sheet

"... They are intended for quick reference to help in determining which color additives may be used in different types of cosmetics, as provided for in Title 21 of the Code of Federal Regulations (CFR), Subpart C of Part 73 (Listing of Color Additives Exempt from Certification), Subpart C of Part 74 (Listing of Color Additives Subject to Certification), and Subparts B, C, and D of Part 82 (Listing of Certified Provisionally Listed Colors and Specifications)." - FDA
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Inspection of Cosmetics

"FDA has the legal authority to inspect cosmetic establishments as well as cosmetics offered for import. Here are resources to learn more about FDA inspection of cosmetics." - FDA
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Cosmetic Adverse Event Reporting Program - Mandatory (PDF)

"In November 2023, FDA updated the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) Web page to recommend that industry responsible persons submit serious adverse event reports for cosmetics by using the current MedWatch Form 3500A that is downloadable and fillable at MedWatch." -FDA
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Shelf Life and Expiration Dating of Cosmetics

"FDA sometimes receives questions from consumers and industry, asking about shelf life and expiration dates for cosmetics. A product’s “shelf life” generally means the length of time you can expect a product to look and act as expected and to stay safe for use. This length of time varies, depending on the type of product, how it is used, and how it is stored." -FDA
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Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

"Whether a product is a cosmetic or a drug under the law is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs." -FDA
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Prohibited & Restricted Ingredients in Cosmetics

"It’s against the law for a cosmetic to contain any ingredient that makes the product harmful when consumers use it according to directions on the label, or in the customary or expected way. This is true whether or not there is a regulation that specifically prohibits or restricts the use of the ingredient in cosmetics." - FDA
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Role & Requirements of U.S. Agent

"Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug imported into the United States (U.S.) must identify a U.S. agent for that establishment.
Outlined in 21 CFR § 207.69(b)" - FDA
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over-the-counter drugs (OTC)

OTC Monographs

A resource for the public to view Administrative Orders (Proposed, Final, and Interim Final Orders) for OTC Monograph Drugs and view OTC Monographs.
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Drug Application Process for Non-Prescription Drugs

"FDA reviews active ingredients and labeling of over 80 therapeutic classes of drugs. There are two regulatory pathways to bring a nonprescription drug to market in the U.S. -- the drug application process and Over-the-Counter (OTC) Drug Review (OTC monograph) process." - FDA
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OTC Drug Review Process | OTC Drug Monographs

"Three-phase public rule-making process resulting in the establishment of standards for an OTC therapeutic drug class. A resource for the public to view OTC Monographs and their Administrative Orders (Proposed, Final, and Interim Final). OTC Monographs@FDA also facilitates the ability for the public to submit, search, and view comments and data for Proposed and Interim Final Administrative Orders, except if otherwise specified." - FDA
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Small Business Assistance - Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) Drugs

"Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) Drugs. An OTC drug product is a drug product marketed for use by the consumer without the intervention of a health care professional in order to obtain the product. Two regulatory pathways exist for the legal marketing of such products ..." - FDA
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Regulatory Information for OTC Drugs - Federal Register Notices, Ingredient References

Federal Register Notices, Ingredient References, and other Regulatory Information.
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OTC Active Ingredients - Alphabetical by Category

A list of OTC active ingredients and their application for use.
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Percents of Actives (Code of Federal Regulations Title 21)

A list of OTC active ingredients and their application for use.
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National Drug Code Directory

FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products.
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OTC Warning Letters

Active warning letters by product category.
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Search for FDA Guidance Documents

This feature is provided to give a convenient way to search for all FDA guidance documents from a single location. It lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.
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Over-The-Counter Monograph Drug User Fee Program (OMUFA)

"The facility fee will be assessed for qualifying persons who own an OTC monograph drug facility, including contract manufacturing organization facilities.

The OTC Monograph Drug User Fee program does not assess a facility fee for human OTC drug products that are produced under an approved drug application. The Federal Register notice referenced above provides more information about FY 2024 facility fees." - FDA
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FDA User Fee Programs

"The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting the public health and accelerating innovation in the industry. The Office of Financial Management (OFM) is responsible for the financial management of the user fee programs. OFM maintains an accounts receivable system used for user fee invoicing, collections, reporting, and data maintenance." - FDA
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Electronic Drug Registration and Listing System (eDRLS)

"Owners or operators of drug manufacturing establishments are required to register their establishments with FDA. Registrants are also required to list each drug manufactured at their establishment(s) intended for commercial distribution and submit updated drug listing information to FDA twice each year, in June and December, notifying FDA if this information has changed." - FDA
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Electronic Drug Registration and Listing Instructions

"There are three steps, or submissions, that are needed to register an establishment and list a drug with FDA. Each of these steps requires an initial submission followed by periodic updates to maintain an accurate and current status. Any establishment, with certain exemptions, engaged in manufacturing, repacking, relabeling or salvaging drug products for U.S. distribution is required to register with FDA." - FDA
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Structured Product Labeling Resources

"The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. The FDA has adopted SPL to enhance patient/customer safety and product usability within its consumer base." - FDA
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MEDICAL DEVICE

Medical Devices

A comprehensive list of product categories that are considered a medical device.
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Medical Device Reporting (MDR): How to Report Medical Device Problems

"Each year, the FDA receives over two million medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products." - FDA
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Medical Device Requirements (21 CFR Chapter I Subchapter H)

FDA medical device requirements.
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DIETARY SUPPLEMENTS

FDA generally does not approve dietary supplement claims or other labeling before use. Under the FD&C Act, a firm is responsible for ensuring that the dietary supplements it manufactures or distributes are not adulterated, misbranded, or otherwise in violation of federal law. (FDA Feb 21, 2024)

Dietary Supplements Overview

"Dietary supplements are regulated by the FDA as food, not as drugs. However, many dietary supplements contain ingredients that have strong biological effects which may conflict with a medicine you are taking or a medical condition you may have. Products containing hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk." - FDA
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Information on Select Dietary Supplement Ingredients and Other Substances

Search FDA's ingredient directory.
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Dietary Supplement Label Database (NIH)

The National Institutes of Health's Dietary Supplement Label Database (DSLD) includes current and historical label information from products marketed in the U.S.
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Dietary Supplement Fact Sheets (NIH)

This collection of fact sheets and other resources from the NIH Office of Dietary Supplements (ODS) and other federal government sources provides information about dietary supplements and their ingredients. These include vitamins, minerals, herbs and botanicals, probiotics, and more.
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Dietary Supplements (USDA)

Find evidence-based information about dietary supplements. This collection of fact sheets presents information about dietary supplements and their ingredients. These include vitamins, minerals, herbs and botanicals, probiotics, and more.
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Dietary Supplements Guidance Documents & Regulatory Information

"To further support the public health goals of the Dietary Supplements Health and Education Act (DSHEA), FDA also issues guidance documents containing nonbinding recommendations to help industry understand and comply with all regulations and the law." - FDA
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Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act

"This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations." - FDA
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Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act

"This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.." - FDA
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Information for Industry on Dietary Supplements

Instructions and links for industry to submit specific notifications and applications for dietary supplements.
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New Dietary Ingredient (NDI) Notification

"If you plan to market a dietary supplement that contains a new dietary ingredient, you must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which you have concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe." - FDA
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New Dietary Ingredient Notification Procedures and Timeframes

"The manufacturer or distributor of a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or of a dietary supplement that contains the NDI, must submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce." - FDA
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Notifications for Structure/Function and Related Claims in Dietary Supplement Labeling

"The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires a person or firm that markets a dietary supplement with certain types of claims in the product labeling to notify FDA about the claim within 30 days after first marketing the dietary supplement with the claim." -FDA
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Small Business Nutrition Labeling Exemption

"The Federal Food, Drug, and Cosmetic Act requires packaged foods and dietary supplements to bear nutrition labeling unless they qualify for an exemption.One exemption, for low-volume products, applies if the person claiming the exemption employs fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a 12-month period. To qualify for this exemption the person must file a notice annually with FDA." - FDA
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How to Submit Label Claim Petitions & Notifications

"In accordance with FDA regulations, hard copy originals of petitions and notifications for food and dietary supplement claims are required to be submitted to the appropriate offices." - FDA
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Dietary Supplement Labeling Guide

"We have prepared this guide to help assure that the dietary supplements sold in the United Stated are properly labeled. This guide applies to dietary supplements produced domestically as well as those produced in foreign countries. Under our regulations, label approval is not required to import or distribute a dietary supplement." - FDA
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Dietary Supplements: An Advertising Guide for Industry (FTC)

"This document provides guidance from FTC staff on how to ensure that claims about the benefits and safety of health-related products are truthful, not misleading, and supported by science. This guidance is intended to help manufacturers and distributors of NDIs and dietary supplements (you) prepare and submit such premarket safety notifications, commonly referred to as New Dietary Ingredient Notifications (NDINs)." - FTC
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FOOD & BEVERAGE

Food Overview

FDA works to assure that the U.S. food supply is safe, sanitary, wholesome, and honestly labeled. This provides a list of consumer updates.
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Questions and Answers on Health Claims in Food Labeling

"Health claims in food labeling are claims that have been reviewed by FDA and are allowed on food products to show that a food or food component may reduce the risk of a disease or a health-related condition. Such claims are supported by scientific evidence and may be used on conventional foods and on dietary supplements to characterize a relationship between a substance (a specific food component or a specific food) and a disease or health-related condition (e.g., high blood pressure)." -FDA
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