Safe Cosmetics Act of 2010

Hello!

We thought that you would be interested in learning that the Safe Cosmetics Act of 2010 was introduced in the US House of Representatives this week.  If passed and enacted this legislation would increase the regulation of cosmetic product in the US and would affect both foreign and domestic companies.

Changes to the cosmetics regulatory system proposed in the legislation include:

1. Requiring all establishments that manufacture package or distribute cosmetics in the US to register with FDA annually and provide contact information, a description of the establishment’s activities, gross receipts, the number of employees, and the name and address of any company that supplies a cosmetic manufacturing establishment with ingredients for its products.  Only the name and address of the companies would be published;
2. Authorizing FDA to establish fees to be assessed on companies with annual gross receipts or sales of more than $1 million to fund the costs of establishing and enforcing the new regulations;
3. Requiring that all cosmetic products, including those marketed for professional use, include a complete list of all ingredients.  The law would also require full listing of ingredients on websites that sell cosmetics;
4. Requiring manufacturers and distributors of cosmetics and ingredients to submit all information they posses on the physical, chemical, and toxicological properties of ingredients, such as function and use, test results, and exposure data to FDA;
5. Require FDA to issue regulations listing ingredients identified by the Agency as “prohibited ingredients,” “restricted ingredients,” or “safe without limits” for use in cosmetics as well as a list of at least 300 ingredients that are not eligible for inclusion on the above lists due to lack of safety data. FDA must also make safety determinations for these ingredients;
6. Prohibiting companies from manufacturing, importing, distributing, or marketing a cosmetic or cosmetic ingredient if the company failed to provide information to FDA as required or if the company’s products contain non-permitted ingredients;
7. Requiring companies to notify FDA if a marketed product “is adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse health consequences or death to humans;” 
8. Authorizing FDA to request a voluntary recall of the affected products, issue an order for the company to cease distribution, and, under certain circumstances, require a recall or issue an emergency recall order or adulterated or misbranded cosmetics;
9. Authorizing FDA to require that cosmetics containing nano-materials be include that information on the labels;
10. Establishing an adverse health effect reporting system;
11. Requiring FDA to publish a list of “alternative testing methods” that do not involve the use of animals to test a chemical substance and that must be used in product testing where practicable.

A voluntary registration and listing program for cosmetic companies is already in place at FDA and most of the proposed requirements simply bring regulation of the cosmetic industry up to standards already required for foods, dietary supplements and other regulated products.  The requirement that FDA list the status of cosmetic ingredients could actually be helpful to industry; particularly to smaller companies who are not members of the Personal Care Product Council (www.personalcarecouncil.org), which has an enormous amount of ingredient information.   

Even though the legislative process has just begun and similar bills submitted in previous years have not gained traction and become law, is not too early for US companies to contact their Representatives regarding the proposed law.  It will also help your company’s long term future to consider implementing programs of information collection and ingredient verification, testing, etc. that help to ensure the quality and safety of your products. 

If you have questions about current Cosmetic regulations or these proposed changes, please contact us. Learn more about us at www.BioTransApp.com.

You can read more about this legislation at the FDA Law Blog: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/07/rep-schakowsky-introduces-safe-cosmetics-act-of-2010-bill-would-increase-regulation-of-cosmetics.html

The blog post also provides links to the legislation itself.

GMPs & Warning Letters for Dietary Supplement Companies

Hello!

I trust that summer is flying by for those of you in the Northern Hemisphere and I hope that winter is not too harsh for those of you in the Southern Hemisphere.

Since dietary supplement companies are now required to comply with FDA’s Good Manufacturing Practices (GMP) regulations, the agency has begun increased inspections and enforcement actions as promised.  In March the agency posted the first warning letter based on the dietary supplement GMPs. The following deficiencies in adherence to GMPs were noted:

1. Failure to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use. In this particular case the company was using an aloe vera gel but the testing methods used were not sufficient to know if the aloe were pure or if it was “a mixture of aloe, thickeners and/or other ingredients.”
2. Failure “to make and keep documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition; and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement”.  So the company had in process tests set up but those processes and tests were not relevant to the product.
3. Failure to “follow your written procedure, ‘Approval/Rejection of Raw Materials and Packaging Components’ for collecting representative samples of each unique shipment of components.”  In other words, the company had standard operating procedures but did not follow them.

The letter goes on to cite several deficiencies with the quality control program, batch records and manufacturing records.  You can read the entire letter at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm210182.htm .

Our goal at Bioscience Translation & Application is to facilitate your success.  We work in association with former FDA staffers who provide GMP and pre-inspection assistance.  Let us know if you need help complying with these regulations. Learn more at www.BioTransApp.com.

You may also be interested in attending a GMP class being offered at the Supply Side West meeting to be held in October in Las Vegas.  While I have not seen the curriculum, the course is being offered by reputable companies.  For course details visit

http://www.supplysideshow.com/2010/west/fda-gmp.html

FDA Warning Letters to Food Companies

Hello!

Everyone who eats believes they know at least a little bit about food labels; some even think they understand them completely. But folks in the food business know that labels can be surprisingly complicated and sometimes even frustrating.

In the past several months FDA has issued a number of warning letters to food companies and many of these letters list labeling violations:

A letter to Mickey’s Snacks notes that the product is mislabeled because not all ingredients are listed and allergens have not been declared.  The presence of ingredients derived from or including Milk, Wheat, Soy, Eggs, Peanuts, Tree nuts, Fish and Crustacean shellfish must be clearly identified.  The species of fish and tree nuts present must also be declared.  You may read the entire warning letter at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm215767.htm

Twin Oaks Community Foods was cited for many violations, including improperly using the nutrient content claim, “Saturated fat free” and for not listing calories from fat or the levels of trans fats in the product.  The nutrition facts box was also not properly formatted.  Read the details at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm216242.htm

Yet another recent warning letter (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm216262.htm) enumerates many GMP violations and also cites Oxford Falls, Inc., a producer of condiments and salad dressings, for failure to list all the subingredients that make up the ingredients that they add to their product. One specific example was that the company used Worcestershire Sauce in some products.  Since this sauce is made up of two or more ingredients, each and every one of them must be listed.   This warning letter further cited the company for improper serving size declarations. Serving sizes are set forth in FDA food regulations and must you must use the standard established for your product.  The most interesting violation noted in this letter was the failure to list a zip code as part of the company’s address.  The inspector that wrote this letter is clearly very detail oriented and did not rely on the statement that appears in every FDA warning letter, “The above violations are not meant to be an all-inclusive list of deficiencies…”

Warning letters are serious matters.  Companies that receive them are given 15 days to respond to FDA’s concerns.  Failure to adequately respond can result in seizure of product, injunctions and other actions.  Labeling problems can greatly impact your business.  FDA inspection and enforcement is on the rise and while importers have typically faced a greater chance of inspection, it is becoming more likely that companies in the US will have their facilities inspected after recent high-profile food contamination issues.  Increased inspection means increase scrutiny of labels, since they serve as a sort of table of contents guiding the inspector to areas of concern in your manufacturing process.

At Bioscience Translation & Application we hope that you never face an inspection you are not ready for and we work with our clients to ensure that their product ingredients and labels comply with FDA regulations. We welcome your questions regarding Food regulations including those for baby formula, pet food, medical foods and foods for special dietary uses. Visit us at www.BioTransApp.com