Food Facility Registration and Biennial Registration Renewal

Hello!

If you are crunched for time during this end of year holiday season, this may be good news from FDA:

In 2003 food and dietary supplement facilities were required to register with FDA. Re-registration or renewal was only required when information about the facility changed. As part of the Food Safety and Modernization Act enacted on January 4, 2011, a new biennial renewal requirement was established and all facilities were to renew their registration by December 31, 2012.  FDA was slow to establish a system to handle the renewals and this week FDA extended the deadline to January 31, 2013 for all food and dietary supplement facilities to renew their registration. 

All foreign and domestic facilities that manufacture or hold food or dietary supplements for sale in the US market must submit the following information:

• Facility name, address, phone number, and emergency contact phone number;
• Parent company name, address, and phone number (if applicable);
• Name, address, and phone number of the owner, operator, or agent in charge;
• Email address for the contact person of the facility or, in case of a foreign facility, the U.S. Agent for the facility;
• All trade names the facility uses;
• Applicable food product categories, as listed on the registration form;
• Name, address, and phone number of a foreign facility’s U.S. agent, and phone number of the facility’s emergency contact if it is someone other than the U.S. agent;
• Certification that the information submitted is true and accurate and that the person submitting the registration is authorized to do so; and
• Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

There is no fee for registration and it can be done online (at Food Facility Registration or using paper or CD-ROM (see Paper or CD Registration).

A helpful set of questions and answers regarding food facility registration is available at Facility Registration Q&A

All of us at FDALabels.com and Bioscience Translation & Application wish you a joyous holiday season and a great year in 2013.
If you would like to subscribe to our FDA update newsletters, please reply to this post.

Regards,
Evelyn

Wrinkles and FDA Cosmetic Update

It has been many months since we’ve posted anything on cosmetic regulations. This edition is to make you aware of recent FDA enforcement actions and some proposed legislation that you should be aware of.

We have had discussions with many of our clients about ‘wrinkle claims’.  Typically we note that cosmetic regulations allow claims regarding how a product cleanses, beautifies, promotes attractiveness, or alters appearance or fragrance and that claims about wrinkle reduction are therapeutic or drug claims.  Many of you have responded with questions similar to ‘what about all the big guys and the stuff they say in their commercials?’  Well, a few of the big guys received warning letters from FDA regarding their claims.

In October FDA sent Avon a warning letter regarding claims made on their website about their Anew line of products. The letter lists a number of claims including

“Rebuild collagen to help plump out lines and wrinkles.

Stimulate elastin to help improve elasticity and resilience.

Regenerate hydroproteins to help visibly minimize creasing.”

The letter also notes claims comparing Avon products to botox and goes on to say, “Your products are not generally recognized among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the [Food Drug and Cosmetic] Act.”

In September Lancôme also received a warning letter noting numerous drug claims on their Genefique line of products.  While one claim cited in the letter did discuss wrinkles, “See significant deep wrinkle reduction in UV damaged skin, clinically proven,” the Lancôme website claimed that their products stimulate stem cells.  It may be that it was the stem cell claims that prompted FDA to act but the fact that wrinkle claims were also cited is noteworthy.

Cosmetics may be promoted to reduce the appearance of wrinkles but not to repair, correct, plump or make them go away.

Now for the future: Last April US Congressman Leonard Lance of New Jersey introduced a Bill in the US House of Representatives.  The Cosmetic Safety Amendments Act of 2012 proposes “to establish new procedures and requirements for the registration of the cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes.” 

For a number of years FDA has had the Voluntary Cosmetic Registration Program (VCRP) in place.  This program is ‘regulations light’ but mirrors the drug listing and registration program.  I have heard rumors that cosmetic good manufacturing practice regulations have been written but have not seen them published this year; which is not surprising since much in government was on hold in 2012 due to the Presidential election and remains on hold awaiting the outcome of Congressional efforts to address looming budget cuts and tax changes. Nevertheless, it is important for cosmetic companies to be aware that they will be affected by future increased regulation.

To learn more about the VCRP, visit http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/default.htm.

To read the proposed legislation visit http://www.gpo.gov/fdsys/pkg/BILLS-112hr4395ih/pdf/BILLS-112hr4395ih.pdfhttp://www.gpo.gov/fdsys/pkg/BILLS-112hr4395ih/pdf/BILLS-112hr4395ih.pdf .

To read an intelligent and information article about the legislation, visit FDALawBlog at http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/representative-leonard-lance-r-nj-introduces-industry-supported-bill-to-modernize-cosmetics-regulation.htmlhttp://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/representative-leonard-lance-r-nj-introduces-industry-supported-bill-to-modernize-cosmetics-regulation.html

To read the Avon warning letter visit http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323738.htm

To read the Lancôme warning letter visit http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm318809.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm318809.htm

I hope you find these periodic posts informative and interesting.  If you  would like to be added to our newsletter distribution list, please reply to this post. 

Contact us with any questions you have regarding cosmetic, food or dietary supplement regulations.

FDA Warning Letters to Cosmetic Companies

FDA Warning Letters to Cosmetic Companies

The US Food and Drug Administration has responsibility to ensure the safety of consumer products through enforcement of regulations on many consumer products, including cosmetics.  Cosmetics are subject to fewer regulations than are foods and drugs and it is not common to see FDA issue warning letters; however, in the past few months FDA has sent warning letters to two cosmetic companies.

In a June letter to Set-N-Me-Free Aloe Vera Company  FDA objected to therapeutic claims on the cosmetic products.  Cosmetics may be marketed to cleanse, beautify, promote attractiveness and alter appearance but not to affect the structure or function of the skin.  While in this warning letter FDA objected to some outrageous claims about cancer, it also included the following claim, which is a lot like many seen in the market today:

“Natural B-vitamins in the safflower and avocado oils [ingredients in this product] help in cell formation and build skin-immune functions. These oils renew skin flexibility by permeating natural vitamins A and E into skin cells, making regeneration of these cells occur faster.”

The claims about immune function and regeneration are problematic, going well beyond cleansing, beautifying, promoting attractiveness and altering appearance.

Last week FDA published a letter sent to Vienna Beauty Products.This was the most disturbing warning letter I have ever read about a cosmetic company. According to the letter Vienna Beauty Products were producing cosmetics under insanitary conditions that included:

“Apparent filth and dust build up on manufacturing equipment in the production area” 

“A layer of sediment and encrusted material was observed on the exterior and tops of production kettles.”

“The last cleaning [of the production room floor] was performed November 2010.”

“The 250 and 500 gallon kettles were last cleaned 15 years ago.” 

“The last cleaning of the 400 gallon shower gel kettle could not be determined.” 

“Additionally, the finished product storage tank and storage totes were said to have last been cleaned over 20 years ago.” 

Not surprisingly, these conditions led to production of products with high bacterial counts.  The scary thing is that Vienna Beauty Products manufactures several private label lines of product for major retailers.

Since registration of cosmetic manufacturing facilities is voluntary, I wondered how the FDA ever discovered all the problems at Vienna Beauty Products.  I noticed that the warning letter was signed by Paul Tietell, District Director of FDA’s Cincinnati District Office.  Mr. Tietell used to be in the Denver District Office and I had the pleasure of serving with him on the board of the Rocky Mountain Regulatory Affairs Society, so I wrote to ask him how cosmetic companies come to FDA’s attention.  Here’s his reply,

“Cosmetic establishments may find their way to FDA's OEI (Official Establishment Inventory) in a variety of ways.  

In addition to the firm registering with FDA through the VCRP, the firm may also be a manufacturer required to register under one of many existing regulations.

The firm may have been involved in a complaint (Consumer, Med-Watch other agency referral) and have been entered into our OEI in conjunction with our receiving and recording of that complaint.

The firm may have come to the attention of a FDA through general surveillance of retail sales, by observation during and employee's day to day operations, or perhaps through observation of an advertisement.”

This means that if you advertise or sell cosmetics, you could be subject to FDA inspection.  It also means that you should review your manufacturing methods against FDA's Inspection Checklist  and be sure to have your labels reviewed for regulatory compliance.

Cosmetic companies provide products to help make the world beautiful and attractive.  The folks at FDALabels.com and Bioscience Translation & Application would like to help you keep your business beautiful.  Contact us if you have questions or need help ensuring that your company is in compliance with FDA regulations.

We hope you find these occasional posts interesting and informative.  You can subscribe to our mailing list by replying to this post.

The Cosmetic Team

FDALabels.com

Bioscience Translation & Application

Dietary Supplement Educational Opportunities

Hello!

Many of our dietary supplement clients have come to us for proactive assistance with proper labeling and other FDA regulatory issues.  Unfortunately, some companies only found us after they had problems and were subject to enforcement action by FDA.  It is expensive and time consuming to have to respond to FDA warning letters or have products held at the border.  Further, some violations raise the possibility of product recalls or even complete removal of the product from the US market.  My team and I do our best to alert our clients and help them understand the FDA’s Good Manufacturing Practices (GMP) regulations and I want to be sure you have heard about two opportunities to learn more about them.

August 22^nd from 1:00 pm to 3:00 pm Eastern Time (Webinar)

The Natural Products Association is Sponsoring a webinar on the GMPs the effect companies that distribute but do not manufacture their own products. FDA calls such companies ‘Own Label Distributors’. I believe this information is crucial for dietary supplements that want to grow and stay out of trouble with FDA. Here is a link to registration for this webinar and a brief description follows:

http://www.npainfo.org/NPA/EducationCertification/NPAGMPWebinar.aspx

FDA says that if your name is on the product, you are responsible for it. The agency has issued numerous warning letters to own-label distributors for GMP violations—Ensure your product is in compliance with GMPs by registering for this webinar. Hear directly from FDA about their expectations are for specific for own-label distributors, re-packagers, and re-labelers, and hear from our industry speaker about how to achieve compliance.

September 13^th and 14^th In person conference in Boulder, CO

Sponsored by The Rocky Mountain Dietary Supplement Forum: What Does FDA Really Expect from Us?

At this day and a half seminar you will learn directly from industry experts.

    Learn how to dramatically change the outcome of your inspection with the Agency

    Hear from FDA Denver District representatives on what they expect during an inspection plus the top 483 items trended by FDA 

    Receive step-by-step instructions and a template on how to respond to 483s and Warning Letters

    Interact with other industry professionals who are facing the same challenges you are

http://www.regonline.com/builder/site/Default.aspx?EventID=1055067http://www.regonline.com/builder/site/Default.aspx?EventID=1055067

We at FDALabels.com and Bioscience Translation & Application hope that you find this information helpful.  If however, you wish to receive these occasional posts as newsletters, please post a reply to this entry.

Meanwhile, we would be pleased to help you with your questions about FDA regulations. 

All the best to you and yours!

Evelyn

An Introduction to Importing FDA-Regulated Products into the US

As posted here previously, FDA has committed to greater inspection of imported products; particularly imported food and dietary supplements (supplements are regulated as a special class of foods).  

We frequently work with companies that wish to import products into the US and have developed the following list of steps necessary to do so.  Note that each step involves many sub-steps not listed here.  Many of the same steps apply to cosmetic products.  Drugs and Medical devices must first be approved or cleared by FDA for use in the US and then steps 4-7 apply to them as well.

Steps to import foods & dietary supplements into the US

       1.  Register the facility where the products are produced and held. FDA Food Facility Registration and What You Need to Know About Registration of Food Facilities

       2.  Review FDA Food Safety requirements and GMP regulations to ensure that the facilities can comply with them since registration puts you on FDA’s inspection list. See FDA webpage on Food Safety

3     3.  If your product is a liquid or gel and preserved by either a) having a low pH or b) being thermally processed, then you must register your facility (a separate registration than 1 above) and submit your processing steps for FDA review and approval prior to shipping product to the US. (Note: FDA uses the term ‘canned’ food to refer to any shelf stable product that has liquid or gel content.) Information for Aseptic Processors and Acidified or Low-Acid Canned Food Registration

4    4.   You must have a US Agent that is physically located in the US to serve as a domestic point of contact and communication with the FDA. US Agent

      5.  You must ensure that your product ingredients are permitted in the US. Unfortunately, there is not a comprehensive list of what is or is not permitted and not everything that is permitted in the EU is permitted in the US. Even FDA's Everything Added to Food in the United States is only a partial list.

i      6.  You must ensure that the product label is in compliance with FDA regulations FDA Food Labeling Guide; Dietary Supplement Labeling Guide; Cosmetic Labeling Guide

      7.  You must notify the FDA of your shipments so then can be inspected upon import. Prior Notice of Imported Foods

NOTE: This list only covers FDA’s side of importing. US Customs and Border Protection has other regulations which are outside of our expertise.  We recommend that you work with a reputable Custom Broker to ensure compliance with those other import regulations.

We at Bioscience Translation & Application and FDA Labels.com hope that you find this information helpful. Contact us with question or post a comment.