Stemming from a February 4, 2019, publicly held meeting hosted by the FDA, citizens, and lawmakers inquired about the oversight powers of the United States Food and Drug Administration (FDA), in regards, to limitations and authorities the agency may or may not have when issues of consumer product regulations come into question. As a result, of the lawsuits and trials pending due to asbestos contamination in talc-based cosmetic products, the agency’s authority seemed to be brought under questioning.
Asbestos Minerals Become Harmful When Disturbed
Asbestos is a group of silicate minerals that can be found naturally in the earth. At times these mineral fibers can also reside in deposits of other natural resources or mineral deposits found in the ground. As in many cases, asbestos has been found in mineral deposits such as coal, vermiculite, and talc.
Asbestos becomes dangerous when it is disturbed from its solid-state or residual form. When those fibers or particles break away, they become airborne and are harmful to anyone who inhales or swallows them. Exposure to asbestos is known to enhance or cause lung disease, lung cancer, and mesothelioma.
Meeting Brought FDA Oversight Authority Into Question
The meeting was the first public meeting that the FDA hosted since the 1970s. The basis for the meeting was not due to accusations or explanations about any particular FDA or governmental short-coming, but for clarification to the consumers, companies, and officials involved with the consumer cosmetic product industry. The primary issue questioned was the FDA’s role in regards to the agency’s authority to oversee consumer goods and cosmetic products.
Under the law, federal regulation of food, drugs, cosmetics, biologics, medical products, and tobacco are mandated by acts of the United States Congress. Ever since these acts were passed, these laws that allow the FDA to have their authority have been modified to include new product markets, expand enforcement power, authorize new funding sources, update surveillance, modernize inspection methods and implement public education initiatives.
Federal Food, Drug, And Cosmetic Act (FD&C) Of 1938
The FDC Act defines cosmetics by their intended use, 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” (FD&C Act, sec. 201(i)). Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
Under the FDC Act, cosmetic products and ingredients do not have to be reviewed or approved by the FDA before they are placed on the market. As noted, no rule requires cosmetic companies to share specific safety information with the agency. On the other hand, the FDA does monitor for potential safety issues with cosmetic products on the market and will take the initiative when necessary to protect the public’s health.
Cosmetic Product Makers Not Required To Share Information With FDA For Approval
Legally, the FDA does not have the authority to require cosmetic product companies to share their information with the agency. Besides, those cosmetic companies are not required or subjected to complete any sort of formal review or approval process before their products can be legally placed on the shelf. In other words, cosmetics products and companies seem to have free discretionary reign in disclosing pertinent information about their products. This issue leads experts to question who holds the key to regulatory safekeeping for consumer safety in cosmetic products.
At the moment, those questions may be on hold. Still, astoundingly there is a voluntary system that does assist the FDA agency in carrying out its responsibility to regulate cosmetics sold here in the United States. Since cosmetic product registrations and filings are not mandatory under the law here in the United States, a voluntary registration system has been organized for use in the domestic cosmetic industry.
Authorities, Consumers, And Representatives Question FDA Regulatory Authority
Here in the United States, health and safety issues involving consumer products sold in this country are monitored by the United States Food and Drug Administration (FDA). The FDA operates under the authority of the Federal Food, Drug, And Cosmetic Act (FD&C) and the Fair Packaging and Labeling Act (FPLA). Also, cosmetic product regulation is dually enforced under the laws outlined in both the FD&C and FPLA Acts.
Voluntary Cosmetic Registration Program (VCRP)
The organized registration system is called the Voluntary Cosmetic Registration Program (VCRP). This voluntary program functions as a self -registered reporting system that manufacturers, packers, and distributors of cosmetic products involved in commercial distribution within the United States, use to register their businesses or products before or after they enter into the distribution chain or marketplace. In effect, the program is strictly voluntary, and there is no underlying requirement whatsoever to register in the system by the FDA or any other agency.
The information gathered from voluntary registrants are compiled into a database and is available for viewing by consumers or healthcare providers who request certain information about products that may or may not contain certain ingredients. The data is available once submitted into the VCRP and can be distributed upon request. The information requested is protected but is also a part of public knowledge that under legal protection can be distributed to professionals or consumers upon request. VCRP program information is gathered and distributed by the FDA. How is this possible? I thought the FDA was not a part of the VCRP. Is the program not a voluntary registration system? In a sense, to the untrained eye, any reasonable person might speculate the process to be disoriented, inadequate, excessive, or just plain unnecessary.
FDA A Portal For Data Transfer From VCRP Program
To clear up confusion, the FDA is taking the information that is gathered from the VCRP database upon request from consumers or professionals and is distributing this information back to the requested party or parties. As a result, the FDA acts as a portal system or catalyst to propel the information from the voluntary database back to the consumers or professionals who made the initial requests for that data or report.
FDA Can Distribute Data Under Freedom Of Information Act (FOIA)
The agency can do this and utilizes this service under the Freedom of Information Act (FOIA). This program essentially mandates publicly accessible “electronic reading rooms” with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features. FOIA allows members of the public to request copies of records not customarily prepared for public distribution.
The FOIA pertains to existing records only and does not require agencies to create new documents to comply with a request. Also, the act does not require agencies to collect information they do not have or to perform research or analyze data for a requestor. Also, FOIA requests must be specific enough to permit an FDA employee who is familiar with the subject matter to locate records in a reasonable time.
U.S. Companies Can Register With VCRP Before Or After Product Is Marketed
Domestic Companies can register with the VCRP before or after they introduce their products into the United States distribution chain or sales market. International companies can also voluntarily register their companies, but only after their products are for sale in the United States. All manufacturers can file statements disclosing a product’s ingredients; these are known as Cosmetic Product Ingredient Statements (CPIS). These statements filed for each product can be entered before or after they enter the market.
In the event that a product is discontinued or altered do to the ingredients or usage application of the product, companies can file amendments to these CPIS forms, similar to amendments used to file IRS tax filings. Stipulations require that amendments to name change and ingredients change must be submitted within 60 days after that particular product enters the distribution chain. Also, product filings for discontinuation must be practically discontinued from commercial distribution within 180 days of the amended discontinued announcement or filing.
Even though the registration systems are voluntary, they seemed to be well organized and are mainly broadcast and supported by the resources of the FDA. Alternatively, if the FDA actually had full authorization to implement mandatory registration requirements for cosmetic product registration and approval through an initial registration system, similar to VCRP, then would the safeguards to protect consumers from questionable or even toxic ingredients be an unthinkable task or would it be the right thing to do, in order to monitor and protect consumers.
FDA Regulatory Authority Recalling Consumer Cosmetic Products Limited
Although the FDA does take the information and safety of consumer product ingredients extremely seriously, there still is the issue of the oversight authority that is afforded to them may be insufficient or substandard when it comes to utilizing their authority over protecting consumers from potentially unsafe or unknown cosmetic products.
It is no secret that the FDA is not authorized to order recalls of cosmetics, but that do monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without adhering to the written requests from the agency.
Manufacturers Who Misrepresent Products Are Breaking The Law
Under the FD&C Act, companies who market misbranded or adulterated cosmetics violate the law. Although cosmetic products do not need FDA approval to be placed on the market to sell, the FDA can still pursue enforcement actions against products out on the marketplace that is not in compliance with the law. Also, if any individuals or entities are knowingly violating the law, the FDA can investigate and pursue legal against them.
Consumer Cosmetic Product Recall System Is Almost Voluntary
Inherently, the recall process is almost similar to the VCRP program or a voluntary registration system. In comparison, recalls of cosmetic consumer products are initiated voluntarily by manufacturers or distributorships, not by the initial authority of the FDA. Inherently, these recalls are voluntary actions undertaken by companies to remove products from the marketplace that might be hazardous or defective from either their intended use or purpose.
FDA Can Pursue Legal Action After Failure To Respond To Written Requests
Again, the FDA does not have the authority to recall these cosmetic products. The agency can still solicit formal written requests to manufacturers or distributors to remember that item[s]. If the company[s] refuse or do not respond to those written agency request[s], the only other option the FDA has is to pursue legal action against those companies.
For example, to prevent a company from shipping out an adulterated or misbranded product, the FDA may request a federal district court to issue a restraining order against the manufacturer or distributor of the suspected cosmetic product. Those cosmetics that are not in compliance with the law may be subject to seizure. “Seizure” means that the government takes possession of the property from someone who has violated the law, or is suspected of doing so. The FDA agency may also initiate criminal action against a person or entity violating the law.
Ingredient Disclosure Requirements Another Example Of Limited FDA Power
Consumers, lawmakers, and others alike question how a federal regulatory authority can oversee an industry, monitor specific consumer products, and still not have the power to require and enforce manufacturers to disclose information about ingredients within products intended to be placed upon shelves to be sold to consumers. Frankly, the whole idea or concept seems like it would be hard to explain.
FDA May Need More Authority To Oversee Consumer Cosmetic Products
The bottom line with the FDA seems to be that the agency does not have the legal authority to police or enforce any more regulatory actions to keep cosmetic consumer goods any safer. In relation, it is not a matter of whether the FDA will or will not do, but the fact of the matter is they are limited to what their current power allows them to do under the law.
An Act Of Congress Would Be Required To Change The Law
In the United States, federal laws are enacted by Congress. To make the rules work on a day to day basis, Congress authorizes government agencies, such as the FDA, to create regulations and instills these certain agencies, like the FDA, to enforce those laws. The only way to change the Federal Drug Administration’s legal authority over consumer cosmetic products would require the law to change. The only way the law could change would require an act of congress.
There Is No Law Required For Asbestos Exposure
Although it may take an act of Congress to change the law, it ultimately does not require one to become exposed to the harmful effects of asbestos. Even though you may not have developed symptoms from asbestos exposure until years later, it is never too late to get the help or assistance you need. Remember, mesothelioma cancer is caused exclusively from exposure to asbestos, and disease can take decades to develop. If you or a loved may be suffering from the harmful effects of asbestos exposure, please do not hesitate to call an experienced asbestos or mesothelioma attorney.