Cosmetics Product Recall under FDA

Cosmetics Product Recall under FDA

Title 21 of the Code of Federal Regulations (CFR), section 7.3(g), describes a recall as a firm’s removal or correction of a marketed product that FDA judges to be in violation of the laws we administer and against which the FDA would start legal action, such as seizure. FDA strongly advises businesses to familiarise themselves with all of the regulations, including the elements of a recall strategy, in 21 CFR Part 7.

What is the FDA’s responsibility in a recall?

The FD&C Act does not give FDA the authority to mandate the recall of a cosmetic, but it does give FDA the authority to request a company to do so. They do, however, actively participate in recalls.

  • The FDA keep track of recall developments. They may perform their own audit inspections at wholesale or retail customers in addition to examining company status reports to ensure the recall’s efficacy.
  • The FDA determines the level of the health risk posed by a product under recall and assigns a classification to represent that risk:
    • Class I: There is a foreseeable risk that using or being exposed to a prohibited product may have grave implications for one’s health or result in death.
    • Class II – Where there is a remote chance that using or being exposed to a contraband product will result in transitory or medically treatable adverse health effects.
    • Class III: No adverse consequences to health is posed by using or being exposed to a contraband product.
  • The FDA or the company may issue a public notification if it determines that it is necessary. The FDA will publish a press statement if the company declines or unreasonably postpones doing so. The FDA Enforcement Report, a weekly publication that includes details on all recalls for which classification has been assigned, is another way that FDA disseminates broad information on recalls.
  • If FDA requests a recall, they create a suggested plan for each recall that specifies how the Agency wants it to be executed and whether a press statement is required. The FDA will analyse and offer comments on the firm’s recall strategy if one is developed.
  • The FDA guarantees that the product is either destroyed or properly refurbished.

What is a cosmetic company’s responsibility in a recall?

The following is what the company is required to do in accordance with 21 CFR Part 7:

  • Customers should be notified by the company. According to 21 CFR 7.49, the notification’s format, content, and scope should be appropriate for the risk the product poses and the recall plan that was created for it.
  • When a recall is announced, the company must inform the relevant FDA district office.
  • Periodic recall status updates should be sent by the company to the relevant FDA district office so that the FDA can monitor the recall’s development.
  • If the company or FDA decides that a public warning is essential, they should submit a statement to that effect along with a distribution strategy for FDA’s assessment and feedback.
  • The business must carry out effectiveness checks in accordance with 21 CFR 7.42(b) (3).
  • Whether the recalled product is destroyed or brought into compliance, the corporation oversees how it is handled.

How can the recall process be easier and more effective?

The simplest method to reduce the workload associated with product recalls is to thoroughly avoid product adulteration and misbranding in the first place. However, by being ready in advance, businesses can reduce the damage in the event that a recall is required.

  • Keep a backup plan in place in case a recall needs to be started in accordance with the recall rules.
  • Give numbers to production lots or batches. Law does not mandate lot numbers for cosmetics. But it enables you to decide if some or all product lots need to be recalled. Since it will probably be impossible to pinpoint the exact production runs implicated if the items don’t have lot numbers, it might be required to recall every product currently on the market.
  • Keep proper distribution data to make it easier to find recalled products. Keep them around for longer than the product’s expected shelf life and utilise.

How to prevent similar problems?

The corporation should take the kind of remedial efforts that stop a similar issue from happening in the future, in addition to the corrective actions of withdrawing a violative product from the market and either destroying it or bringing it into compliance.

  • Identify the cause of the violation,
  • decide what adjustments need to be made to prevent the issue from occurring again
  • execute such modifications

When conducting an inspection in connection with a recall, an FDA inspector may check for these factors.


What is a Recall Strategy?

A recall strategy is a predetermined course of action to be followed in carrying out a given recall, considering the scope of the recall, the requirement for public warnings, and the extent of effectiveness checks.
Recalling firm refers to the company that requests a recall or, in the case of a recall requested by the FDA, the company that oversees the production and marketing of the recalled product.

What is the procedure for a Recall?

1.       Initiation of a Recall. Includes voluntary, and non-voluntary recalls.
2.      Identification of the Action as a Recall; Classification; and Strategy. By determining that the action satisfies the requirements of a recall under 21 CFR 7.3(g)1 or the applicable definitions for recalls carried out under various regulatory or statutory authorities, FDA formalises the recall action. FDA evaluates the data, including the firm’s recall plan, determines the level of health risk the recalled product presents, and then classifies the recall in line with 21 CFR 7.41.
3.      Notification and announcement to the public. FDA evaluates a company’s recall strategy and makes improvements, such as the publication of a public statement. FDA notifies the company of the recall’s categorization. The agency has the right to publish a recall statement on its own. Other federal and state government agencies, as well as international governments, receive recall information from FDA.
4.      Recall monitoring and auditing. In order to make sure that the recall action has been successful, FDA designs and implements a recall audit plan.
5.      Termination of a Recall. The FDA decides when to call off a recall.

What is Recall Enterprise System (RES)?

The FDA’s recall staff submits, updates, categorises, and ends recalls using the Recall Enterprise System (RES), an electronic data system. Safety Alerts for medical devices are also recorded using it. Stock recoveries and market withdrawals are typically not recorded in RES. However, divisions may be instructed by the Center Recall Unit (CRU) or OSPOP/DE/ROB to enter a specific market withdrawal into RES and to monitor and audit the action in the same way as a recall, if this is done in accordance with agency policy.

What is a Recall Alert?

Once the division recall coordinator is aware that a recall has been started and has the appropriate information, the division will send a recall alert via the RES within one working day. Additionally, alerts may be sent even before a recall has begun. A firm’s correction or removal, the cause of the recall, and the predicted categorization are all disclosed in the recall alert in order to inform the appropriate Center Recall Unit (CRU) and OSPOP/DE/ROB. Copy the division recall personnel where the production site or responsible firm is located for recalls where the responsible firm or manufacturing site is located outside the monitoring division.

FDA’s Adverse Event Reporting for Cosmetics

FDA’s Adverse Event Reporting for Cosmetics

Cosmetic ingredients and products are not required to have FDA clearance before being sold in the U.S. The only exception is colour additives, which need to be authorised for their intended purpose (apart from the colouring agents used in coal-tar hair dyes). Companies and individuals that sell cosmetics have a legal obligation to guarantee the security of their products. The FDA requires trustworthy evidence that shows that a cosmetic product is harmful when used as directed by its label or in the usual or anticipated manner before they take safety measures against it.

Adverse events in Cosmetics

The FDA keeps an eye on cosmetics sold on the market to make sure people may use them safely. When a consumer, manufacturer, or medical practitioner submits an adverse event report (AER), FDA may learn of a safety concern. Any issue that occurs after using a cosmetic product might be considered an adverse event.

The main categories of hair care (including shampoos, conditioners, hair smoothing treatments, and hair dyes) and skin care products are where cosmetic product adverse events are most commonly recorded. In addition, rinse-off products are reported more frequently than leave-on ones. Certain products have been the focus of numerous adverse reports in recent years.

The data about the adverse report is sent to CAERS by the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, which serves as the entry point for reports about all products subject to FDA regulation.

These reports are not yet confirmed, and this data is unprocessed. However, they are crucial as it is one of the FDA’s few tools to track any cosmetics-related safety issues. Care must be used while interpreting the reports. The database can provide the public with some broad information about the types of difficulties if any, that other users have reported encountering if anyone is considering utilising a certain product.

How do FDA take action on these adverse safety reports?

FDA constantly monitors adverse event reports and reviews the relevant scientific literature. The following step is to coordinate an examination of the production facilities with the FDA’s Office of Compliance. The FDA may send warning letters informing businesses that they have noticed legal infractions based on what they discover during an examination. The FDA work with companies to facilitate the voluntary recalls of products. They occasionally inform the public about potentially dangerous products, which may motivate businesses to cooperate with the FDA in seeking a resolution.

In addition to placing a product on import alert or detaining it, if it seems hazardous or improperly labelled, the FDA now has the option of collaborating with the Department of Justice to take legal action.

The FDA further maintains a watch out for products distributed as cosmetics that falsely promise to change the body’s structure or function. Such claims are illegal for cosmetics to make.

How should one report an adverse event to the FDA?

FDA encourages consumer and medical professional reports of adverse events that are as detailed as possible, including the name and contact information of the individual who experienced the reaction as well as demographic data, such as age, gender, and ethnicity, to help identify whether any particular groups are disproportionately affected. They also want details on any medical interventions, their results, and the product believed to be responsible for the adverse event, including its purchase location and intended usage. Any identifying information about the product, such as the batch and lot numbers, is very crucial in order to find the manufacturer and, if required, to aid in a recall.

The FDA aims to increase the number of reports from health professionals and patients who have encountered an adverse event by making the Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) database public. Increased transparency will lead to more thorough reports, making it easier for the FDA to spot warning signs of potential safety issues with the products being regulated. Anybody can file a complaint about the safety or quality of conventional food, cosmetics, or dietary supplements subject to FDA regulation.


Which substances are not allowed to be used in cosmetics?

Bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants, and hexachlorophene are among the components that are restricted or outright banned by regulations.
Cosmetic and fragrance trade organisations have advised avoiding or restricting the use of a number of components linked to health hazards in addition to those that are governed by law or were the focus of a court decision.
Even if a cosmetic does not include an ingredient that is expressly forbidden or restricted by law, it is illegal to promote one that is hazardous to consumers when they use it as directed on the packaging or in the usual or anticipated manner.

What steps does the FDA take to prevent hazardous pollutants like lead from being present in cosmetic products?

The FDA keeps an eye out for possible safety issues, including hazardous pollutants, in cosmetics that are on the market. In order to be aware of potential issues, FDA also keep up with scientific studies. FDA pursue legal action against businesses and people who sell illegal goods as well as against the products themselves.
·         Examining Imports
Working with U.S. Customs and Border Protection personnel to monitor imported products is one method the FDA protects against tainted cosmetics. FDA issues Import Alerts to assist inspection employees in looking out for items that are most likely to pose a safety danger since we are unable to check every shipment. Several of our import alerts for cosmetics raise the possibility of hazardous contamination in certain products. Cosmetics that are deemed dangerous are prohibited from entering this nation.
·         Examining Manufacturers
In order to prevent the formation of two types of pollutants, nitrosamines and 1,4-dioxane, during the manufacturing process, the FDA has provided instructions to manufacturers. FDA inspectors ensure manufacturers are following the correct processes by conducting inspections.

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Animal testing for Cosmetics

Animal testing for Cosmetics

The term “animal testing” refers to procedures carried out on living animals for research into basic biology and diseases, evaluating the efficacy of new pharmaceuticals, and testing the safety of consumer and industry products such as cosmetics, household cleaners, food additives, pharmaceuticals, and industrial/agrochemicals for human health and/or the environment.

Since 1937, people have used animals to test cosmetics and pharmaceuticals. To determine a product’s safety, manufacturers who want to sell new cosmetic products may utilise animal testing. Companies may decide that animal testing is required in some situations to ensure the safety of a product or ingredient after carefully weighing potential alternatives.


The Food and Drug Administration (FDA), in charge of enforcing the Federal Food, Drug and Cosmetic Act, forbids the sale of mislabelled and “adulterated” cosmetics but does not demand safety tests on animals.

Animals are employed to evaluate the safety of cosmetic goods. The FDA encourages the development and use of alternatives to whole-animal testing as well as adherence to the most humane procedures feasible within the bounds of scientific competence. The Animal Welfare Act and the Public Health Service Policy on Humane Care and Use of Laboratory Animals are two laws, along with other rules and policies that govern animal testing that FDA supports and abides. Additionally, the FDA promotes using the least possible numbers of animals in research and testing while still using the most humane techniques feasible within the bounds of scientific capabilities. This is relevant in all situations when animal testing is employed. 

“Cruelty-Free” or “Not Tested on Animals” on cosmetic labelling

On their labels or advertising, several cosmetic firms claim that their products are “Cruelty-Free” or “Not Tested on Animals.” Because these terminologies don’t have any official definitions, cosmetic manufacturers are free to use them as they please.

Some companies could limit these claims to their final cosmetic products. To confirm the safety of their products or ingredients, these companies may rely on raw material suppliers or contracted laboratories. Other cosmetic manufacturers may utilise a combination of scientific research, non-animal testing, testing for the safety of raw materials, and controlled human-use testing to support the safety of their products.


Previously, the Chinese government mandated that all cosmetics products undergo animal testing. Fortunately, some of these rules have been removed from Chinese cosmetics regulations. In 2014, China encouraged companies that produced ‘common’ cosmetics (such mascara or shampoo) domestically to avoid using animals in testing, although imported goods were still subject to the requirement. China revised its regulations in 2021 to allow some businesses to bring in common cosmetics without first subjecting them to animal testing. However, “special use” cosmetics like sunscreens and hair colour still need to be tested on animals, and many non-animal test techniques are still not authorised by Chinese authorities.


In the European Union, testing cosmetics on animals and marketing such products became prohibited in 2013. This paved the door for efforts to identify alternatives to the typical cosmetics tests that employ animals. Similar laws have been enacted in Iceland, India, Israel, Mexico, Norway and Switzerland. Animal testing by cosmetic firms in the US and elsewhere prevents them from selling their goods in these nations until they modify their procedures. Legislation banning the sale of cosmetics that were tested on animals has been approved in California, Hawaii, Illinois, Maine, Maryland, Nevada, New Jersey, and Virginia. Several Brazilian states, as well as Australia, Colombia, Guatemala, New Zealand, South Korea, Taiwan, and Turkey, have established legislation that prohibits or restricts the use of animals in the testing of cosmetics.


Numerous products presently on the market are created using components with a lengthy history of safe usage and don’t call for extra testing. Businesses can guarantee safety by deciding to use such materials to manufacture products. Additionally, companies can choose between utilising currently available non-animal testing or investing in and creating non-animal tests for novel substances. There are already nearly 50 non-animal tests available, and many more are being developed. These contemporary alternatives can more nearly simulate how people react to cosmetic components and goods than animal experiments, and they are frequently quicker and less expensive. In place of old animal tests that were established decades ago, advanced non-animal testing reflects the most current approaches that science has to offer.

Some businesses utilise animal testing to determine the safety of new compounds before developing or incorporating them into their cosmetic goods. Some claim that this method is unnecessary and cruel because businesses can already create innovative products with hundreds of chemicals that have a track record of safety and don’t need any more testing. Furthermore, alternative, quicker, less costly, and more trustworthy procedures have replaced antiquated animal experiments. These methods include computer models and human cell-based studies.

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.