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Wednesday, November 20, 2013

FDA Cannot Issue Cosmetic Recall

In a previous post entitled "Cosmetics Sold to Consumers with No FDA Screening" the FDA’s lack of authority over consumer cosmetics was discussed. More detail, however, is owed regarding the FDA’s inability to force product recalls.

Regarding the recall policy for cosmetics the FDA's website reads, “FDA has no authority under the FD&C Act to order a recall of a cosmetic, although it can request that a firm recall a product.”

This places the full responsibility for product safety and recall on the cosmetic firm or manufacturer. But what of harmful products released without proper internal safety screening? Is the FDA truly helpless to enact restrictions? In the case of a voluntary cosmetic recalls the FDA does monitor a recall’s progress and can submit recall request if a firm is otherwise unwilling to withdraw the a known harmful product from the market.

This active involvement assists firms in monitoring cosmetic recalls and taking the appropriate action. Consumers play a large part in reporting cosmetic product failures through MedWatch online or by calling 1 (800) 332-1088. Once discovered, the FDA conducts private testing on cosmetics reported to be potentially harmful. If product testing reveals a safety issue the FDA may seek legal intervention to prohibit further sale of the cosmetic.

Upon the discovery of a damaged or adulterated product, if a company refuses to recall the cosmetic the FDA can pursue legal action through the Department of Justice. The charges brought against a cosmetic firm will vary depending on the health hazard classification and other factors. The FDA may also request a restraining order against the manufacturer or ask that the government seize the contaminated product, thereby removing the product from market by legal force.

Per the FDA’s website legal action may include:
asking a federal court to issue an injunction
requesting that U.S. marshals seize the products
initiating criminal action
refusing entry of an imported cosmetic
requesting that a company recall a product

Though the FDA cannot independently require specific action they work with cosmetic companies and the federal government to safeguard products. Voluntary recalls are the most common occurrence as cosmetic firms partner with the FDA to ensure recalls are effective and thus avoid litigation. The FDA monitors the recall process, privately evaluating the potential hazard, as well as outlining a potential recall strategy and facilitating public notification. These measures are taken as a way to support responsible manufacturing and provide necessary guidance through the recall process and guarantee public awareness.

Cosmetic firms and manufactures should stay ahead of hazards by instating quality protocols, performing correct labeling practices, and finding a contamination testing facility to monitor formula purity. Firms should also know their responsibility during a recall and how to prevent future problems.

Wednesday, November 13, 2013

Cosmetics Sold to Consumers with No FDA Screening

The U.S. Food and Drug Administration has no regulatory authority over cosmetics across consumer markets. Certain ingredients are prohibited regardless of product type, but there is no FDA pre-market approval required to sell cosmetics to consumers.

As stated on the FDA.gov website:

“In general, except for color additives and those ingredients that are prohibited or restricted by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic, provided that--
the ingredient and the finished cosmetic are safe under labeled or customary conditions of use,
the product is properly labeled, and
the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces."

While color additives demand FDA inspection all other ingredients in a formula are only subject to companies’ internal safety and testing regulations. Cosmetic firms and manufactures are responsible to ensure the safety of their product. This is accomplished in part by thorough ingredient testing to gather a comprehensive understanding of the cosmetic’s active and inactive ingredients. Manufacturing quality assurance and any necessary failure analysis studies should also be performed to preserve a product’s quality.

Cosmetic firms and manufactures are not required to have any sort of FDA license to operate; however, the FDA does encourage all companies to participate in the Voluntary Cosmetic Registration Program (VCRP).  This program alerts the FDA to any new products released and provides information such as products ingredient lists as well as distributor and manufacturer information. This voluntary program in conjunction with independent panels such as the Cosmetic Ingredient Review (CIR) assists in the monitoring of cosmetics currently on the market. In addition to reviewing recorded information the FDA can inspect cosmetic manufactures per the FD&C Act to ensure compliance with the law.

Though the FDA monitors cosmetics in these ways, if a product is found to be harmful to consumers or to violate safety and labeling laws the Administration does not have the authority to demand a recall. What they can do, and what action can be expected will be discussed in a future post. 

This lack of external requirements constitutes the primary operating differences for cosmetics versus other monitored consumer goods. Cosmetic firms must, however, still submit to branding and adulteration legal restrictions. In light of this, manufactures of cosmetics should fully equip themselves to know the legal requirements specific to cosmetics and develop practices to ensure compliance. As part of this effort in product safety, firms should employ formulation testing to verify labeling and take measures to protect against product contamination.

Thursday, November 7, 2013

Light-Induced Structural Transformation of Polymers in Liquids

Polymers are used in a multiplicity of functions and range in structure and type. Most commonly when referring to polymers one may think of plastics or rubber. However, Szymon Wiktorowicz at the University of Helsinki uses lasers to selectively dissolve polymers to create transparent images in otherwise cloudy polymer solution.

Szymon, a doctoral student at the university, has successfully synthesized polymers that are photochemically active and dissolvable in water as well as in certain alcohols. This polymer chain includes azo compounds which account for its transformative behavior. When subject to a laser of 365-nm the semi-dissolved polymer transitions from the trans to cis forms via reversible photoisomerization. The trans to cis shifts occur across the whole polymer chain. This causes the polymer to dissolve completely leaving a distinguishable clear spot in an otherwise uniformly cloudy liquid.

The effect is not permanent but can last a matter of hours depending on the solvent type and concentration. Aqueous solutions have shown to have lower critical solution temperature (LCST) behaviors while the polymers exhibit upper critical solution temperature (UCST) transitions in alcohol solutions.

This study is monumental as drawing with light has been found effective on solid surfaces but never before accomplished within a liquid.

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