The U.S. Food and Drug Administrations (FDA) current regulation of cosmetics is relatively lax compared to the way the Agency regulates drugs, biologics, medical devices, and other FDA-regulated industries.  However, that all may change if the Safe Cosmetics Act of 2010 becomes law. 

The bill (H.R. 5786), introduced this week, would alter the regulatory scheme of cosmetics in the U.S. to more closely reflect the way that FDA regulates the other industries under its purview.  The Safe Cosmetics Act of 2010 would maintain the current Food, Drug, and Cosmetic Act sections 601-603 concerning adulterated and misbranded cosmetics but would add a new subchapter that would include, among other provisions:

• A requirement that domestic and foreign establishments that manufacture, package, or distribute cosmetics to register FDA annually; 

• Establishments would be required to provide FDA with specific information about their products and provide FDA with a description of the establishments activities and gross receipts.  Manufacturers would have to supply FDA with contact information for each of its ingredient suppliers;

• A requirement that FDA establish a “schedule of feesto provide for oversight and enforcement” of the new cosmetics regulation.  Such fees would only be assessed to companies with gross receipts or sales of more than $1 million;

• The requirement that all cosmetics labels, both for retail sales and professional use, “bear a declaration of the name of each ingredient in such cosmetic in descending order of predominance;”

• A requirement that cosmetics manufacturers and distributors submit to FDA all information about “the physical, chemical, and toxicological properties of single or multiple chemicals listed on the cosmetic labels.”  The information to be submitted would include function and uses, tests of cosmetics, and exposure and fate information;

• A prohibition on companies from manufacturing, importing, distributing, or marketing a cosmetic or cosmetic ingredient if the company has not provided FDA with the information required under the regulations.  Also, the bill contains a prohibition on companies from manufacturing, importing, distributing, or marketing if the companys product contains any non-permitted ingredients;

• A mandate that adverse health effects associated with the use of a cosmetic be reported;

• The requirement that responsible parties notify FDA if a marketed cosmetic is adulterated or misbranded is a way that the use of or exposure to the cosmetic (or any ingredient or component of the cosmetic) would likely cause serious health consequences or death.  FDA may request a voluntary recall of the affected products, issue a cease and desist order to stop the company from distributing, and/or require a recall or issue an emergency recall order;

• A requirement that FDA issue regulations that includes lists of ingredients the FDA classifies as “prohibited ingredients,” “restricted ingredients,” or “safe without limits” for use in cosmetics.  These regulations must be issued within two years of enactment of the Safe Cosmetics Act of 2010.

• A requirement that FDA develop a “priority assessment list of not less than 300 ingredients” that cannot be included on the three lists mentioned above “because of a lack of authoritative information on the safety of the ingredient.”  FDA must determine the safety of these ingredients.

• A requirement that FDA publish a list of “alternative testing methods” that do not involve using animals to test chemical substances; and

• FDA authorization to require cosmetics containing “nano-scale” materials be labeled as such.

Currently, cosmetic establishments do not have to register with FDA.  Additionally, there is no regulation requiring that a cosmetic ingredient be approved by, or listed with, FDA prior to use.  The FDA, under 21 C.F.R. parts 710 and 720, has established the voluntary cosmetic registration program which allow firms to voluntarily register their facilities and list their products and ingredients.  FDA does regulate color additives more strictly with some requiring certification prior to use.  FDA regulations also prohibit or restrict certain ingredients for cosmetic use.  However, the provisions of the Safe Cosmetics Act of 2010 would greatly alter the current structure of the regulation and allow the FDA a much more invasive approach to the regulation of cosmetic firms. 

Rep. Jan Schakowsky (D-IL), with Reps. Ed Markey (D-MA) and Tammy Baldwin (D-WI), introduced the bill just five days after the Personal Care Products Counsel (PCPC) announced that the organization had sent a letter to health policy leaders in Congress calling for changes in FDA regulations.  Many of the PCPC proposals are included in the Safe Cosmetics Act of 2010. 

The provisions of this new bill could significantly transform the way that the cosmetic industry does business.  Heightened scrutiny and regulation by the FDA would lead to greater cost for cosmetics manufacturers, distributors, and importers. 

For more information on FDA regulation of the cosmetic industry or how this new bill could affect your business, please contact us at contact@fidjlaw.com.

On May 27, 2010, the United States District Court of the District of Columbia granted a summary judgment in the matter of Alliance for Natural Health US v. Sebelius, suggesting that a qualified health claim is free speech protected under the First Amendment. Sparked by the FDAs denial of a petition to approve qualified health claims, The Alliance for Natural Health (“ANH”) along with prominent dietary supplement activists, Durk Pearson and Sandy Shaw sought to invalidate the FDAs denial of the qualified health claims and permanently preclude the FDA from preventing dietary supplement marketers from placing qualified health claims on dietary supplement labels.

The ANH petitioned the FDA with ten qualified health claims touting a reduction in cancer risk from selenium. The FDA rendered a decision completely rejecting two of the ten claims, calling them misleading for a failure to state the type of cancer risk associated with the benefits of selenium supplementation. The FDA further denied seven other claims that delineated site-specific cancers citing a lack of scientific evidence. The last claim dealt with a reduction in the risk of prostate cancer. Given the scientific evidence, the FDA, deemed the prostate claim to be false and misleading but did not discard it. Instead, in an uncharacteristic move, the FDA proposed a redrafted version of the prostate claim, which the ANH deemed pointless and the Court, ironically, found to be false and misleading.

The Court, relying on the FDAs own Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims and prior case law, declared that the FDA had violated the First Amendment when it chose to suppress the qualified health claims rather than find a less restrictive means such as a short, succinct disclaimer. While the Court did not grant the permanent injunction ANH had requested, it did send the petition back to the FDA for re-review.

Unless reversed on appeal, this decision will make it almost impossible for the FDA to deny a qualified health claim that accurately reflects the scientific evidence; it would conflict with supplement marketers rights to free speech. This could pave an easy path for dietary supplement labels to bear appropriately disclaimed qualified health claims on selenium or presumably any other dietary supplement.

New legislation is changing the way chain restaurants and vending machine operators do business. On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (“PPACA”). The PPACA includes a provision that requires certain chain restaurants and vending machine operators to disclose some nutritional information on the foods and beverages they market and sell. This nutrition disclosure provision, Section 4205 of the PPACA, amends the Federal Food Drug and Cosmetic Act (“FDCA”) by specifically inserting a new subclause (H) into Section 403(q)(5) of the FDCA.

Nutritional Disclosure Requirements

Chain Restaurants:

The nutritional disclosure requirements apply to restaurants and similar retail food establishments that is part of a chain with 20 or more locations doing business under the same name and offering substantially the same menu. These chain restaurants must disclose in a “clear and conspicuous manner” the following required nutritional information on menus and menu boards, including drive-through menus:

¢ The number of calories contained in the standard menu item as usually prepared and offered for sale. The calorie disclosure statement must be adjacent to the name of the standard menu item and clearly associated with the standard menu item.

¢ A suggested daily caloric intake statement posted prominently on the menu, menu board, including drive-through menus, that is designed to enable the public to understand the context and significance of the calorie information posted on the menus and menu boards.

In addition, the menu or menu board must inform consumers that the above required calorie count and suggested daily caloric intake statement, as well as the nutritional information normally found on the Nutrition Facts Panel on packaged food is available in written form on the restaurants premises.

Vending Machines:

A vending machine operator who owns or operates 20 or more vending machines must comply with the applicable nutritional disclosure requirements. The law requires that if the vending machine does not provide visible nutritional information, such as the Nutrition Facts Panel, before purchasing, then the vending machine operator shall provide a sign in close proximity to each article of food or the selection button that includes a clear and conspicuous statement disclosing the number of calories contained in the food or beverage.

Self-Service Food and Food on Display:
The nutritional disclosure provision requires that food sold at a salad bar, buffet line, and cafeteria line, as well as self-service beverages or food that is on display and is visible to customers must place a sign next to each food offered that lists calories per displayed food item or per serving.

Exceptions:

The nutritional disclosure requirements do not apply to the following:

¢ Items that are not listed on a menu or menu board (such as condiments);
¢ Daily specials;
¢ Temporary menu items appearing on the menu for less than 60 days per calendar year;
¢ Custom orders; or
¢ Such other food that is part of a customary market test appearing on the menu for less than 90 days.

Reasonable Basis for Nutrient Content

Restaurants are given some flexibility in determining the calorie count information included on their menus, menu boards, and written information. The restaurant must have a “reasonable basis” for the nutrient content disclosures, including nutrient databases, laboratory analysis, and other reasonable means. This flexibility protects the restaurants from the unavoidable variation found any given serving.

Menu Variability and Combination Meals

The Secretary of the Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), shall determine how nutrient content for standard menu items that come in different flavors, varieties, or combinations, but that are listed as a single menu item (for example, pizza, ice cream, soft drinks, and doughnuts) are to be disclosed and labeled.

Regulatory Power to Expand Disclosure Requirements

The law provides that the federal regulators may expand the nutrient disclosure requirements to include additional nutrients if doing so would assist consumers in maintaining healthy dietary practices.

Federal Preemption

Many states and local governments have already adopted their own nutritional disclosure laws. This federal nutritional disclosure law preempts state and local menu-labeling requirements that are not identical to the federal menu-labeling requirements. Note, however, that the federal law does not preempt state and local requirements for food labels that provide a warning concerning the safety of the food or food component.

Voluntary Compliance

Restaurants and vending machine operators who are exempt from these requirements may elect to voluntarily provide the nutritional data. Those who wish to voluntarily comply with the program may register with the FDA and meet the program requirements. The Secretary of HHS is required to publish within 120 days of enactment the terms by which restaurants and vending machine operators may voluntarily provide nutritional information.

Compliance Date

Chain restaurants and vending machine operators that are subject to the new law are not required to comply with the requirements until the Secretary of HHS finalizes and implements the regulations. The law requires the Secretary of HHS to publish proposed regulations within one year of the laws enactment date of March 23, 2010. Therefore, while the new law takes effect immediately, retailers do not have to take mandatory action until the rules are further clarified.

Fuerst Ittleman will continue to monitor the Secretary of HHS and the FDA for proposed rulemaking concerning this new law. If you are an owner or operator of a restaurant, vending machine, self-service food restaurant, gas station franchise, or large food distributor who services 20 or more corporate or school cafeterias with the same food products, please contact us at (305) 350-5690 or contact@fidjlaw.com to determine how this new federal law may impact your business.