Cosmetics Regulations – Page 2

Lead Acetate in Cosmetics

Since 1980 lead acetate has been considered a safe color additive for use in cosmetics for hair coloring. In 2017, a color additive petition requesting repeal of regulation that allows for the use of lead acetate in cosmetics was submitted. After carefully reviewing the submission and other relevant information, FDA concluded that there is no reasonable certainty of no harm from this use of lead acetate. On October 30, 2018, FDA published a final rule banning the use of Lead Acetate in cosmetic products intended for hair coloring. The rule is effective from December 03, 2018 and the industry has 12 months to make the transition and reformulate their products. Such products must comply with the requirements of 21 CFR 73.2396, including the specifications, uses and restrictions, and labeling requirements.

Hair dye products containing Lead Acetate are required to bear such a warning statement:

CAUTION: Contains lead acetate. For external use only. Keep this product out of children’s reach. Do not use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after each use.

Manufacturers and labelers of cosmetic products must comply with FDA labeling requirements otherwise their products are considered misbranded and are subject to detention.

Liberty Management Group Ltd. can help companies with labeling compliance. Our label experts check your labels against current labeling regulations and help you avoid detention and import refusals.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 25, 2019

ALPHA HYDROXY ACIDS

AHA are used in some cosmetics and drug products applied to the skin. Cosmetic products containing AHAs are marketed for a variety of purposes, such as smoothing fine lines, improving skin texture and tone, unblocking pores etc. AHA containing products cause exfoliation or shedding of the surface skin. The extent of exfoliation depends on the concentration of AHA and other ingredients in the product.

Some products that contain high concentration of AHAs or other acids act as skin peelers. Such products are regulated as drugs by FDA. For example, acne treatment products or skin lighteners are considered drugs. FDA has received many adverse reports for AHA containing products listing adverse reactions such as skin burning, peeling, rash, swelling, blisters, increased sunburn etc. FDA has found that applying AHAs to skin results in increased UV sensitivity.

FDA recommends using AHA containing products strictly according to the label directions. It is advisable to use skin protection. FDA also recommends that the labeling of a cosmetic product bear a statement that conveys the following information:

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Liberty Management Group Ltd can help you make sure all elements of your product label are compliant to FDA regulations. LMG provides a wide range of services assisting companies with label compliance, ingredient compliance, FDA registration etc.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: August 29, 2019

Cosmetics vs Drugs

Cosmetics are defined by FD&C Act as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. For example, skin moisturizers, perfumes, lipsticks, fingernail polishes, cleansing shampoos, hair colors, and deodorants etc.

Drugs, on the other hand, are defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals.

Some products meet the definition of both cosmetic and drugs. For example, a cleansing shampoo is a cosmetic as its intended use is to cleanse the hair. An antidandruff treatment is a drug as its intended use is to treat dandruff. As a result, an antidandruff shampoo would fall under both cosmetic as well as drug. Another example is that of a toothpaste with fluoride, anti-perspirant deodorants, moisturizer with sun protection claims.

A product’s intended use is determined based on either the claims made on the label, advertisements, company website, general perception about the product in consumers mind or by the ingredients present in the product.

The FDA requirements of cosmetics and drugs are different. Below is an outline of the key differences:

FDA approval – FDA does not approve cosmetics except for color additives. On the other hand, every new drug needs an approval or conformity to FDA’s OTC monograph.
GMP – FDA has no set regulations for cosmetic GMP. There are only guidelines that cosmetic companies need to refer to. But for drug companies, FDA has laid clear regulations that drug companies need to comply with.
FDA registration – Cosmetic registrations are voluntary. Drug Registrations and listings are mandatory.
Labels – Cosmetic labels need to comply with cosmetic labeling regulations while OTC Drug labels require compliance to OTC drug labeling regulations and combination drugs requires compliance to regulations specific to combination product labeling.
NDC number: Drug products are required to have a labeller code while cosmetics are exempt from the requirement

Liberty Management Group Ltd provides assistance with FDA Registration for Drugs and Cosmetic Establishments, Label compliance, US Agent service and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 31, 2019

Color Additives in Cosmetics

FDA regulates cosmetic products and its ingredients. Color additives are added to cosmetic products to improve their appearance. Color additives are subject to strict system of approval under the FD&C Act. Failure to meet US color additive requirements may cause a cosmetic to be adulterated and make it subject to detention at the port of entry.

The FDA requirements for color additives that are added to cosmetics are as follows:

All Color additives must be approved by FDA. There must be a regulation specifically addressing a substance use as a color additive, specifications and restrictions.
Along with approval, many color additives are also required to be batch certified by FDA if they are to be used in cosmetics marketed in the US. This means that FDA chemists have analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation—called a “listing regulation”—for that color additive. FDA determines the need for batch certification based on whether the color additive needs this level of control to protect the public health. Some color additives, in their uncertified forms, might contain impurities at levels that pose a health concern.
Color additives may only be used as stated in the regulations pertaining them including maximum permissible concentration in the finished product.

FD&C Act categorizes color additives into two main types:

Those subject to certification – Petroleum based color additives aka coal tar dyes or synthetic organic colors. Such colors usually have 3-part names e.g.; FD&C Yellow No. 5
Those exempt from certification – Obtained primarily from mineral, plant or animal sources.

A list of color additives approved for use in cosmetics can be found here https://www.fda.gov/industry/color-additives-cosmetics/color-additives-listed-use-cosmetics-code-federal-regulations

Some color additives are approved for use for one use and excluded for use in another.

To ensure that the cosmetic products do not contain any unapproved color additive or other unapproved ingredients, a manufacturer can avail LMG’s label and ingredient review service.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 03, 2019

FDA policy on Cosmetic recalls

What is a recall?

A recall is when a company withdraws its defective or contaminated products, from the market, that FDA considers to be in violation of laws, and that are likely to invoke a legal action such as seizure.

Role of FDA

Under FD&C Act, FDA does not have the authority to order a recall of cosmetic, but it may request a firm to do so. FDA is actively involved in:

Monitoring the progress of a recall by conducting own audit checks at wholesale or retail customers to verify the recall’s effectiveness.
Evaluating the product under recall and assigning a classification to indicate degree of hazard posed by the product.
Ensure a public notification is issued either by itself or by the firm.
Develop recall strategy or review one developed by the firm.
Ensure that the recalled products are destroyed or reconditioned suitably.

FDA classifies recalls under three categories:

Class I: for situations where products may cause serious health hazards or death
Class II: for situations where the product may cause temporary or medically reversible health consequence
Class III: for situations where product is not likely to cause adverse health consequences

Role of a Cosmetic Firm

When a product is found to be in violation, a cosmetic firm must:

Notify its customer
Notify FDA
Submit periodic recall status reports to appropriate FDA district office
Issue a public notification, if necessary
Destroy the products or act to bring them into compliance.

To minimize the damage caused by a product recall, a cosmetic firm must:

Prevent product adulteration and misbranding
Maintain a contingency plan in case a recall does happen
Assign production lot numbers to track the possible affected products
maintain adequate records to determine the location of products.

FDA has detailed regulatory procedures regarding what to expect if an FDA investigator conducts an inspection related to a recall. The objective of such inspection is to identify the root cause for the recall and to ensure that the firm has taken measures to prevent the reoccurrence of such problems and their cause. FDA takes the following steps:

Issue Notice of Inspection
Discuss problem with management
Investigate all circumstances which may affect products deficiency
Review records, logs for violative lots
Review firm’s quality control data
Determine if any actions are taken or planned to prevent similar occurrences.
Determine what actions are taken or planned for products still in commerce.

Liberty Management Group LTD is one of the leading FDA consulting groups in the USA. LMG provides assistance registrations, labels, and many more FDA regulations.

Namrata Gusain

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on March 20, 2019

PROHIBITED AND RESTRICTED INGREDIENTS IN COSMETICS

FDA Registration for Cosmetic Products and Cosmetic Establishments is voluntary and FDA does not approve cosmetic products or ingredients before they go on the market. It is the responsibility of cosmetic manufacturer to ensure the safety of its products.

As per FD&C, it is prohibited by law to distribute any cosmetic containing an ingredient that makes the product harmful when used exactly as per label directions or as per the customary use. The only exception to this rule is for coal tar hair dyes for which FDA cannot take action against as long as the product label contains a special warning statement and also contains directions for a skin test.

Color additives are permitted in cosmetics only if FDA has pre-approved them for the intended use.

FDA specifically prohibits or restricts following ingredients in cosmetics:

Bithionol – Prohibited as it may cause photo contact sensitization
Chlorofluorocarbon propellants – Prohibited for use in cosmetic aerosol products intended for domestic consumption
Chloroform – Prohibited as it causes cancer in animals and is likely to be harmful to human health, too. Except for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient
Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide) – Prohibited as it may cause serious skin disorders.
Hexachlorophene – Prohibited because of its toxic effect and ability to penetrate human skin. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips
Mercury compounds – Restricted to eye area products at no more than 0.0065 percent of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available
Methylene chloride – Prohibited as it causes cancer in animals and is likely to be harmful to human health, too
Prohibited cattle materials – These materials include specified risk materials, material from no ambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef
Sunscreens in cosmetics
Vinyl chloride – Prohibited for use as an ingredient of aerosol products, because it causes cancer and other health problems
Zirconium-containing complexes – Prohibited in aerosol cosmetic products because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin

FDA may take action against any such cosmetic manufacturers or products on the market that do not comply with the law.

Cosmetic labels must always carry directions for use as some cosmetics are safe when used the correct way and unsafe when used the wrong way. Cosmetics must have any directions for use or warning statements needed to make sure people use the products safely. For example; some ingredients are safe on skin if washed off immediately but not if left on skin for hours or some ingredients that are safe for use on hair but not safe when used near eyes.

Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with Registrations, Label compliance, and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on February 27, 2019

Are cosmetics FDA approved?

Cosmetics are defined as articles intended to be rubbed, poured, sprinkled, sprayed or applied to human body for cleansing, beautifying, or altering appearance.

FDA does not approve cosmetics.

Under the law, cosmetic products and ingredients do not need FDA premarket approval. However, FDA can enforce action against cosmetic products on the market that are not in compliance with the law, or against establishments or individuals who violate the law.

It is a legal responsibility of cosmetic manufacturers or distributors to ensure the safety of their products.

All the cosmetics labels must be FDA compliant. Although FDA does not approve cosmetics labels, there are limits that apply to cosmetic labeling claims. As per law, all information on cosmetic labeling including claims must be truthful and not misleading.

If the FDA determines that a product is adulterated or misbranded, there are several actions the agency might take namely; criminal penalties, detention at port or file in an injunction to prevent the company from manufacturing the product.

FDA encourages cosmetic manufacturers and packers to register themselves by way of VCRP (Voluntary Cosmetic Registration Program) and submit the information of their products currently marketed in US by submitting CPIS (Cosmetic Product Ingredient Statement). Although the submission is voluntary, it provides FDA with an estimate of the information available on cosmetics and their ingredients, the frequency in which they are used and the establishments that are engaged in manufacture, packaging or distribution.

The submission of registration, filing of cosmetic product ingredient, assignment of registration number or CPIS number does not imply that the FDA has approved such establishment or its products.

Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with VCRP, CPIS, Label Review and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: January 23, 2019