FDA ACNE REGULATIONS

USFDA regulates acne products and treatments under drugs, cosmetics, and medical devices.

Acne Drug Products

  • OTC Monograph Compliance: OTC acne treatments products must comply with the FDA’s ” Topical Acne Drug Products for Over-the-Counter Human Use ” (Monograph ID:  M006). This monograph specifies the active ingredients, dosage forms, labeling, and conditions under which these products can be marketed without a prescription.
  • Active Ingredients: Commonly used active ingredients in OTC acne products include benzoyl peroxide, salicylic acid, and sulfur. Each active ingredient has specified concentration ranges and usage guidelines.
  • Labeling Requirements: The FDA mandates specific labeling for OTC acne products, including indications for use (e.g., “for the “management/treatment of acne”), directions, warnings, and any potential adverse effects.
  • New Ingredients: If an acne product contains an active ingredient which is not FDA’s OTC monograph, then it must go through the New Drug Application (NDA) process to be approved.
  • cGMP compliance: All acne products must be manufactured in compliance with cGMP regulations.

Acne Treatment Medical devices

  • Device Classification: Acne treatment devices (e.g., light therapy devices) are classified into Class I, Class II or PMA devices based on their risk to patients. Most acne devices fall under Class II, which requires 510K clearance by proving that the device is substantially equivalent to a legally marketed device.

Cosmetic Acne Products

  • Definition: If a product is marketed as a cosmetic (e.g., cleansers, toners, or non-active ingredient-based products claiming to “reduce the appearance of acne”), it is not subject to the same requirements as drugs or devices. However, it must still be safe to use and properly labeled.
  • Label Claims: Cosmetic products must not make drug claims on the labels.

Liberty Management Group, as a leading FDA regulatory consulting firm, can guide the companies to determine how the products are regulated and help them with the registration process.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

LABEL COMPLIANCE

FDA labeling compliance requirements vary for each product. In general, information on the label must be truthful and not misleading, labels should include all the required information for the product category, wording and formatting should be easy for consumers to understand.

Below are basic requirements for each product category.

Food

  • Ingredient list
  • Nutrition information panel
  • Allergen warnings
  • Name and address of the manufacturer.
  • Net quantity of contents

Medical Devices

  • Intended use of the device
  • Directions for use
  • Warnings and precautions
  • Sterilization information (if applicable)
  • Manufacturer information

Drugs

  • Drug facts table.
  • Intended use of the drug with active ingredients concentration.
  • Warnings and precautions.
  • Directions of use
  • Inactive ingredients
  • Manufacturer information
  • Expiration date

Cosmetics

  • Principal Display Panel (PDP)
  • Product Name
  • Identity Statement
  • Net quantity and Ingredient list
  • Warning and Precautions

The FDA provides comprehensive guidance documents to help navigate the complexities of labeling compliance.

The FDA does not pre-approve labels, so manufacturers are responsible for ensuring compliance.

Liberty management Group, LTD as a leading FDA consulting firm provides assistance with Food, Drug, Medical devices and Cosmetics labeling compliance.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

U.S AGENT

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a food, drug, medical device, and cosmetics imported into the United States must identify a U.S. agent for that establishment.

Information about a foreign establishment’s U.S. Agent must be electronically using the FDA FURLS system or CDER/ESG and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment should provide the name, address, telephone, and e-mail address of the U.S. agent.

Responsibilities of a U.S. agent

The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S and they cannot use P.O. BOX as the address. U.S agents must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include:

  • Assisting FDA in communications with the foreign establishment, meaning that function as a mediator between the client and the FDA.
  • Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States,
  • Assisting FDA in scheduling inspections of the foreign establishment and
  • If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

Liberty Management Group, a leading FDA consulting firm provides assistance with US agent services all foreign food, drug, medical devices and cosmetics establishments.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

WHO NEEDS TO REGISTER WITH FDA?

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of human and animal drugs, biological products, medical devices, food (including animal food), cosmetics, and tobacco products. It also regulates electronic products that emit radiation.

Foods:

The FDA regulates the safety, labeling, and quality of all other food products except for meat, poultry, and egg products, which are regulated by the US Department of Agriculture (USDA).

In general, it includes Fresh and processed foods, Dietary supplements, Bottled water, Food additives, Infant formulas, fruits, and vegetables.

Drugs:

The FDA regulates the safety, effectiveness, and quality of all human and animal drugs, which includes prescription and over-the-counter drugs, homeopathic drugs, active pharmaceutical ingredients and vaccines and other biological products.

Medical Devices:

The FDA regulates the safety, effectiveness, and quality of all medical devices used in humans which includes a wide range of devices, from simple bandages to complex surgical implants.

Cosmetics:

The FDA regulates the safety of all cosmetics, including makeup, skincare products, and hair care products, Hair care products, lotions, and moisturizers.

Products are categorized based on the label claims and regulated according to intended use.

Liberty Management Group Ltd, as a leading FDA consulting firm providing assistance with FDA registration of food, drug, medical devices and cosmetic products.

Liberty Management Group Ltd, as a leading FDA consulting firm will provide assistance with above all regulatory requirements.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.ushttp://www.fdahelp.us

COSMETIC OR DRUG

The classification of a product as a cosmetic or a drug by the U.S. FDA depends on its intended use of the product and how it is marketed. The products are regulated differently based on the classification.

Cosmetic:

As per FDA, a cosmetic is defined as a product “intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body’s structure or functions.” Examples include skin moisturizers, perfumes, body cleansers, haircare products, moisturizers, and other skincare products.

FDA has introduced a new regulation under Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for registering the manufacturing facility with FDA and doing product listings.

Drug:

A drug is defined as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body.” This includes over the counter (OTC) medications, prescription drugs, and even some products marketed as dietary supplements.

Drugs are subject to more stringent regulatory requirements, including pre-market approval processes. They must demonstrate safety and efficacy before being allowed on the market.

It’s important to note that the intended use of a product, as determined by its marketing claims, is a key factor in determining its regulatory classification. If a product is intended to cleanse, beautify, or enhance appearance without making drug claims, it is likely to be classified as a cosmetic. If the product claims to treat or prevent a specific condition or disease, it may be classified as a drug.

However, some products, known as “cosmeceuticals,” may have characteristics of both cosmetics and drugs. These products claim to have therapeutic benefits but are often marketed as cosmetics. The classification can sometimes be nuanced, and companies must carefully consider their product claims and formulations to ensure compliance with FDA regulations.

If a product is classified as drug, then it must comply with all applicable drug regulations including establishment registration, cGMP and drug listing.

Liberty Management Group, as a leading FDA regulatory consulting firm, can guide the companies to determine how the products are regulated and help them with the registration process.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us