Tag: misbranded

Real Hair Truth Cosmetic/Beauty Product Injury Lawsuits

the real hair truth

Injuries from cosmetic products can come in a wide variety of forms — from allergic reactions to infections and other complications. There are two main legal theories that a person injured by a cosmetic product (the plaintiff) could sue under: product liability and breach of warranty. This article discusses what a plaintiff in a cosmetic injury suit must prove under either theory, cases specifically related to allergic reactions, and the possibility of class action lawsuits.

Product Liability: The Basics

The most likely theory to be used in a lawsuit involving cosmetic product injuries is product liability. An injured plaintiff can sue both the manufacturer and/or the seller (the defendant) of the cosmetic product if his or her injury was caused by a defect, a defective design or improper labeling. Most states follow what is called the “strict product liability” rule, although a few still use traditional negligence rules.

A plaintiff suing under a strict liability theory simply needs to prove:

  • that he or she was the kind of consumer that the defendant intended to use the product
  • that the defect did not occur after the product was sold, and
  • that the plaintiff was injured.

This kind of theory is called “strict liability” because many of the requirements in a standard negligence case, like proof of a specific duty of care owed to the plaintiff, are not included. Most states adopted strict liability for mass-marketed consumer products because, among other things, the manufacturers needed to be financially responsible for their products, and not be allowed to escape liability simply because of the difficulty plaintiffs faced trying to prove negligence claims.

In a negligence case (in those few states that still use this theory for consumer products), the plaintiff will need to prove:

  • that he or she bought the product from the defendant
  • that the defendant should have known that the product could be dangerous if unaccompanied by proper warnings, or that the product had a defect
  • that the failure to warn the plaintiff, or the defect or defective design, injured the plaintiff, and
  • that the plaintiff didn’t do anything to cause the injury.

Breach of Warranty

A cosmetic product injury case based on a breach of warranty theory will be the same as other standard breach of warranty cases.

An injured plaintiff could sue for breach of an express warranty if the seller or manufacturer made specific guarantees that a product would have specific effects that the product did not have (note that this theory might not fit with most cases involving an actual injury).

The plaintiff could also sue for breach of an implied warranty that the cosmetic product was fit for normal use, i.e. the implied guarantee that no normal cosmetic product would cause an injury if used properly.

Finally, the plaintiff could sue for breach of an implied warranty that the product was fit for a specific purpose, i.e. that the defendant knew the plaintiff wanted to use the product for a specific purpose, but the product caused an injury when the plaintiff tried use it.

There are many state and federal laws controlling breach of warranty claims. Some breach of warranty claims may not be appropriate when the plaintiff is suing for physical injuries, if the law only allows compensation for the money lost on the product (what is called “economic damages”).

Some warranty laws, however, do allow a plaintiff to sue for physical injuries. Perhaps more importantly, proving a breach of warranty can help prove a strict liability or negligence claim. A plaintiff is not limited to suing under one theory, so including a breach of warranty claim in a cosmetic injury lawsuit will generally help a plaintiff’s case overall.

Injuries Caused by Allergies

If a manufacturer knows, or should know, that a product might cause an allergic reaction in some people, injured plaintiffs could potentially sue the manufacturer for failing to warn about the allergic reaction under a strict liability or negligence theory. A breach of warranty theory might also be possible if the allergic reaction is not extremely rare, i.e. the product was not fit for cosmetic use because some percentage of the population was allergic.

Class Actions for Cosmetic Product Injuries

If a cosmetic product causes many or all of its users the same kind of injury, then a class action may be possible. In a class action case, multiple plaintiffs with the same kind of injury from the same source sue the defendant in one lawsuit.

If someone is injured by a cosmetic product, they or their attorney should research whether there is already a class action case or a settlement fund for people injured by the product. Often, even though the case has settled, there will be a fund to pay those who were not a part of the original case.

Real Hair Truth what makes a cosmetic misbranded?

The Beautiful Lies

The film “Beautiful Lies” release date will be in 2014

In our beautiful world cosmetics hold a strong life in the world of personnel beauty. According to the U.S Government this is a definition of what is “Misbranded”.  Realize my friends that in this day and age government is in everything you do, and with the past and current behavior of the U.S Government would you even take there word on just about anything. Politicians cannot even agree on anything anymore, there life span as a senator, congressman, house representative is for life. Your freedom of speech is going down the drain. So why would you take the word of the FDA. According to the United States Food and Drug Administration (FDA), its responsibilities include “protecting the public health by assuring that foods, cosmetics are safe, wholesome, sanitary and properly labeled.” This responsibility entails regulating a large number of companies producing this nation’s food, making appointments to the high-level positions within the agency very important.  Most high-level FDA employees have a background in either medicine or law, but one of the largest private-sector sources is the Monsanto Company. Over the past decades, at least seven high-ranking employees in the FDA have an employment history with the Monsanto Company.

Well aware of its accused ‘revolving door’ connection with the FDA and other government agencies, Monsanto has issued several press releases denying collusion with the government. In fact, it posted on its official website that collusion theories relating to these agencies, including the FDA, “ignore the simple truth that people regularly change jobs to find positions that match their experience, skills and interests.  ”

Monsanto’s statements help shed light on the balancing act regularly occurring on Capitol Hill when appointments to these top agency positions arise. The importance of the food, cosmetic industrys cannot be overstated and, therefore, the pending question remains: Do Americans want industry insiders regulating it, or those from the academic realm?

What makes a cosmetic misbranded?

Section 602 of the FD&C Act [21 U.S.C. 362] describes what causes a cosmetic to be considered misbranded:

“A cosmetic shall be deemed to be misbranded–

  • (a) If its labeling is false or misleading in any particular.
  • (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
  • (c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
  • (d) If its container is so made, formed, or filled as to be misleading.
  • (e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 721. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 601(a)).
  • (f) If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.

Note that under the FD&C Act, the term “misbranding” applies to–

  • False or misleading information,*
  • Lack of required information,
  • Conspicuousness and readability of required information,
  • Misleading packaging,
  • Improper packaging and labeling of color additives, and
  • Deficiencies where the Poison Prevention Packaging Act requires special packaging.

*Note: According to the FD&C Act, a determination that labeling is “misleading” includes considering both what the label says and what it fails to reveal:

“If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual” (FD&C Act, sec. 201(n); 21 U.S.C. 321(n)].

In addition, a cosmetic marketed in violation of the FPLA or any regulations issued under its authority is considered misbranded within the meaning of the FD&C Act [15 U.S.C.1456(a)]. For cosmetics offered for sale as consumer commodities, the FPLA–

  • requires further label information, such as the product’s identity [15 U.S.C.1453], and
  • authorizes the implementation of regulations to specify the proper presentation of required label information, require an ingredient declaration, and prevent deceptive packaging [15 U.S.C.1454 (c)]

The FPLA defines a consumer commodity, as it applies to FDA-regulated products, as:

“any food, drug, device, or cosmetic (as those terms are defined by the Federal Food, Drug, and Cosmetic Act …, and any other article, product, or commodity of any kind or class which is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or use by individuals for purposes of personal care or in the performance of services ordinarily rendered within the household, and which usually is consumed or expended in the course of such consumption or use.” [15 U.S.C.1459(a)]

Note that the FPLA defines a consumer commodity by the way it is marketed, not the way it is labeled. Labeling a product with words such as “For Professional Use Only” does not keep your product from being considered a consumer commodity under the FPLA.

Labeling regulations are very complex. Detailed information on cosmetic labeling is available in FDA’s Cosmetic Labeling Manual and the labeling regulations themselves [21 CFR 701].

You Should know FDA Authority Over Beauty/Cosmetics

 
Sorry everyone I’m not selling hair care, or teaching haircuts, or color but what I can give you is information that you should know. I have been in the Beauty/Cosmetic industry for well over 25 years and take it from me, a product is here yesterday and gone tomorrow. In Cosmetology school there is a lack of education being given to the student on laws of products, what a manufacturer can say and not say ie (labeling, ingredient’s). What governmental agency’s are there for the protection of the independent stylist and also for the salon employee. Many, many individuals will set up blogs, websites telling you how to overcome customer relations, how to hair color, how to haircutting, and often these individuals will set up a class telling you how to make a ‘Facebook page”. I see this alot at the beauty shows in my industry. But I never really see the hard facts being given to the professional. Its easy to skirt the issues of the beauty industry, “Keep the dumb”, I say. Which to me is so very sad. Many of my fellow professionals are given a line of BS, and are insulted by manufacturers and so-called beauty icons and magazine and websites. Not really taking the issues that are needed for change in my industry, Product knowledge is what they will get and only enough education to buy a product the manufacturers are pushing. Below is important information you should know about the FDA, and how it will help you within your profession. Never, never take the sales persons,distributors or manufactures word as law in the beauty/cosmetic industry, investigate on your own and come to your on conclusions. And if you see a so-called beauty industry “ICON’ pushing a product, WATCHOUT, they are basically being paid to SELL that product!
What does the law say about cosmetic safety and labeling?
The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act1 (FD&C Act) and the Fair Packaging and Labeling Act2 (FPLA). The Food, Drug & Cosmetic Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act involving product composition–whether they result from ingredients, contaminants, processing, packaging, or shipping and handling–cause cosmetics to be adulterated and subject to regulatory action.
 
Under the FD&C Act, a cosmetic is adulterated if–
“it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual” [with an exception made for hair dyes];
“it consists in whole or in part of any filthy putrid, or decomposed substance”;
“it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health”;
“its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health”; or except for hair dyes, “it is, or it bears or contains, a color additive4 which is unsafe within the meaning of section 721(a)” of the FD&C Act. (FD&C Act, sec. 601).
 
Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. Under the FD&C Act, a cosmetic is considered misbranded if–
“its labeling is false or misleading in any particular”;
“its label does not include all required information;
“the required information is not adequately prominent and conspicuous;
“its container is so made, formed, or filled as to be misleading”;
“it is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act; and
“its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.” (FD&C Act, sec. 602)
In addition, under the authority of the FPLA, FDA requires an ingredient declaration to enable consumers to make informed purchasing decisions. Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act. It is important to understand that Congress passes the laws that govern the United States. To put those laws into effect, Congress authorizes certain government agencies, including FDA, to create and enforce regulations, but only as authorized under the law. A change in FDA’s statutory authority over cosmetics would require Congress to change the law.
Does FDA approve cosmetics before they go on the market?
FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologic, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law.
Must cosmetic manufacturers register with FDA?
Manufacturers are not required to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries to FDA. However, companies are encouraged to register their establishments and file Cosmetic Product Ingredient Statements with FDA’s Voluntary Cosmetic Registration Program11 (VCRP).
Can FDA inspect cosmetic manufacturers?
FDA can and does inspect cosmetic manufacturing facilities10 to assure cosmetic product safety and determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.
What actions can FDA take against firms that market adulterated or misbranded cosmetics?
FDA may take regulatory action if it has information to support that a cosmetic is adulterated or misbranded. The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market. To prevent further shipment of an adulterated or misbranded product, the agency may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. Violative cosmetics may be subject to seizure. FDA also may initiate criminal action against a person violating the law. In addition, FDA works closely with the U.S. Customs and Border Protection8 to monitor imports. Under section 801(a) of the FD&C Act, imported cosmetics9 are subject to review by FDA at the time of entry through U.S. Customs. Products that do not comply with FDA laws and regulations are subject to refusal of admission into the United States. Violative products must be brought into compliance (if feasible), destroyed, or re-exported. FDA takes regulatory action based upon agency priorities, consistent with public health concerns and available resources.
 
Can FDA order the recall of a hazardous cosmetic from the market?
Recalls of cosmetics are voluntary actions taken by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective. FDA categorizes a firms action as a recall (as opposed to a market withdrawal) when it determines that the product hazard or defect represents a violation of the FD&C Act. FDA is not authorized to require recalls of cosmetics but does 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 FDA’s written request. Recalls are addressed in Title 21 of the Code of Federal Regulations (CFR), sections 7.40 through 7.59.
Who is responsible for substantiating the safety of cosmetics?
Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the following warning statement appears conspicuously on the principal display panel of the product’s label:
“Warning–The safety of this product has not been determined.” (21 CFR 740.10)
In addition, regulations prohibit or restrict the use of several ingredients5 in cosmetic products and require warning statements6 on the labels of certain types of cosmetics. In general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly , and the use of the ingredients does not otherwise cause the cosmetic to be adulterated or  under the laws that FDA enforces.
 
Joseph Kellner Hairdresser/Mua/Film Producer