Tag: personal care

Retail Regulation In The Cosmetic Industry

real hair truth
The $71 billion personal care product industry in the United States is largely unregulated, and retailers are stepping up to fill the void.

When retailers adopt policies on the safety of the products they sell, it’s called retail regulation.

There is a rich history of retailers using their purchasing power to effect positive market change.
In 2008, when Walmart—the world’s largest retailer—agreed to stop selling baby bottles, sippy cups and sports water bottles made with BPA, it forced manufacturers to reformulate in order to keep selling to this retail giant.
More and more retailers are adopting store wide policies governing the safety of their beauty products, with Whole Foods leading the way by implementing a basic chemical safety screening for all its personal care products and adopting a restricted-substances list made up of more than 400 chemicals prohibited from products bearing its premium standards labels.
In 2008 CVS stepped up to the plate by adopting a store-wide policy prohibiting the use of certain
toxic chemicals in their store-brand baby products. Walgreen’s and Target followed suit in 2013 by
announcing they would develop and adopt comprehensive cosmetic safety policies to govern the
safety of the private-label and national brands they carry.
The following goals should guide retailers’ policies and practices to improve the safety of personal
care products sold in their stores:
Expand the sale of safer cosmetics and personal care products (products free of chemicals
linked to cancer, birth defects, developmental harm and other health concerns).
Adopt a list of chemicals that are banned from use in private-label and national brands sold
in their stores, and ensure that toxic chemicals are replaced with safer alternatives.
Reformulate private-label products to eliminate chemicals of concern.
Practice the highest level of transparency by sharing the company’s safe-cosmetics policy,
practices and progress on websites and in corporate responsibility reports.
Strive for continuous improvements in policies and practices by monitoring scientific
research regarding emerging chemicals of concern.
Federal Regulations
Major loopholes in federal law allow the cosmetics industry to put virtually any chemical into a
cosmetic or personal care product with no pre-market FDA safety testing or review, no monitoring
of health effects, and inadequate labeling requirements. Most of us assume the FDA regulates
these products just as it does food and drugs to assure safety. In fact, cosmetics are one of the least
regulated consumer products available to the public. To make matters worse, contaminants in a
finished cosmetic product that occur as by-products of the manufacturing process, by law, don’t
have to be listed on the product label. That means chemicals like PFOA can hide in a cosmetic or
personal care product without consumers knowing.
The Federal Food, Drug and Cosmetics Act (FFDCA) includes 112 pages of standards for food and
drugs, but just a single page for cosmetics. The cosmetics title of the FFDCA, which has not been
amended significantly since it was enacted more than 77 years ago, provides virtually no power to
perform even the most rudimentary functions to ensure product safety in an estimated $71 billion
cosmetic industry.
Fortunately, for the first time in 77 years, Congress could close the gaping holes in our outdated
federal law and give the FDA the statutory authority and resources it needs to effectively regulate
the safety of cosmetics and personal care products. Currently, Congress is considering two bills to
regulate cosmetics ingredients.
The Senate
On April 20, 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the
Personal Care Products Safety Act of 2015, an important bill with the potential to give the cosmetics
industry a desperately needed makeover. Many strong provisions in the bill would advance the
FDA’s ability to protect consumers from unsafe chemicals in cosmetics and personal care products:
Requiring companies to register their facilities, products and ingredients with the FDA;
Closing labeling loopholes by requiring full ingredient disclosure for professional salon
products and web-based sales of cosmetic products; and
Directing the FDA to assess the safety of a minimum of five cosmetics chemicals a year.
However, the bill falls short of what is needed. Ideally, federal regulation would put in place a robust
safety standard and elevate the rigor of ingredient safety reviews by the FDA and manufacturers to
ensure that cosmetics and personal care products are as safe as possible

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].

Safe Cosmetics? USDA stamp of approval in organics!

Cosmetics, Body Care Products, and Personal Care Products

USDA regulates the term “organic” as it applies to agricultural products through its National Organic Program, if a cosmetic, body care product, or personal care product contains or is made up of agricultural ingredients, and can meet the USDA/NOP organic production, handling, processing and labeling standards, it may be eligible to be certified under the NOP regulations. Know this my fellow industry professionals. This is the governmental agency who will certify a beauty product as “ORGANIC”!

The operations which produce the organic agricultural ingredients, the handlers of these agricultural ingredients, and the manufacturer of the final product must all be certified by a USDA-accredited organic certifying agent. Once certified, cosmetics, personal care products, and body care products are eligible for the same 4 organic labeling categories as all other agricultural products, based on their organic content and other factors.

“100 percent organic” – Product must contain (excluding water and salt) only organically produced ingredients. Products may display the USDA Organic Seal and must display the certifying agent’s name and address.

“Organic” – Product must contain at least 95 percent organically produced ingredients (excluding water and salt).

 Remaining product ingredients must consist of nonagricultural substances approved on the National List or nonorganically produced agricultural products that are not commercially available in organic form, also on the National List. Products may display the USDA Organic Seal and must display the certifying agent’s name and address.

 “Made with organic ingredients”– Products contain at least 70 percent organic ingredients and product label can list up to three of the organic ingredients or “food” groups on the principal display panel. For example, body lotion made with at least 70 percent organic ingredients (excluding water and salt) and only organic herbs may be labeled either “body lotion made with organic lavender, rosemary, and chamomile,” or “body lotion made with organic herbs.” Products may not display the USDA Organic Seal and must display the certifying agent’s name and address.

Less than 70 percent organic ingredients- -Products cannot use the term “organic” anywhere on the principal display panel. However, they may identify the specific ingredients that are USDA-certified as being organically produced on the ingredients statement on the information panel. Products may not display the USDA Organic Seal and may not display a certifying agent’s name and address. (Water and salt are also excluded here.)

 Cosmetics, Body Care Products, and Personal Care Products

 Any cosmetic, body care product, or personal care product that does not meet the production, handling, processing, labeling, and certification standards described above, may not state, imply, or convey in any way that the product is USDA-certified organic or meets the USDA organic standards. The USDA has no authority over the production and labeling of cosmetics, body care products, and personal care products that are not made up of agricultural ingredients, or do not make any claims to meeting USDA organic standards. Cosmetics, body care products, and personal care products may be certified to other, private standards and be marketed to those private standards in the United States. These standards might include foreign organic standards, eco-labels, earth friendly, etc. USDA’s NOP does not regulate these labels at this time.