Updates for Food & Dietary Supplement Companies

I recently participated in the FDA /Joint Institute for Food Safety and Applied Nutrition (JIFSAN http://jifsan.umd.edu/) Food and Nutrition webinar.  The webinar covered topics including food labeling, infant formula, medical foods, color additives, partially hydrogenated oils and dietary supplements.  Most of the presenters that talked about labeling regulations focused on the proposed changes to the nutrition facts box, which we highlighted several months ago (http://tinyurl.com/me9rekg).  I want to share with you a few things I found interesting. 

I had heard some rumblings that the yet to be published final rule would very closely resemble the proposed rule and after listening to the FDA staff presentations, I expect that to be true.  As I read the proposed rule when it was first published I focused on the proposed changes and not FDA’s rationale for the various proposals.  The webinar presentations highlighted the rationale behind the proposals, convincing me that the agency is confident of the merits of the proposed rule and that much of it will remain intact in the final rule

For example, industry groups submitted comments on the proposed rule objecting to the proposal to declare total sugars and added sugars.  However, the proposal is rooted in the 2010 Dietary Guidelines for Americans that recommends reducing the intake of calories from solid fats and added sugars.  The presenter, Crystal R. Rivers of FDA’s Nutrition Programs in the Office of Nutrition, Labeling and Dietary Supplements, stated that on average, Americans get 16% of their total calories from added sugars and noted that labeling added sugars would encourage food manufacturers to reduce added sugars and help Americans to identify products with added sugars; compare products for amount of “added sugars” and reduce extra calories consumed by Americans.

Another speaker, Cherisa Henderson, Nutrition Programs Staff, Office of Nutrition, Labeling and Dietary Supplements, talked about the proposal for dual nutrition labeling that would list the calories  and nutrients both a single serving and in the entire package for products that “can reasonably be consumed in a single-eating occasion”.   The proposal would mean that any product with 4 or fewer servings per container would list the nutrition facts per serving and for the whole container. Ms. Henderson presented findings from consumer studies that demonstrated that consumers were more aware of serving sizes and calories when both sets of information were presented.  FDA prides itself on being a science based organization and based on the data presented, I expect that FDA’s proposal to list the nutrition data for entire packages to be in the final rule.

The FDA presenters were repeatedly asked when various final rules on Food Safety Modernization and nutrition labeling would be published.  None of the speakers would venture a guess and one even said, "Hopefully in my lifetime."  We'll let you know as soon as we know.

---

Renew Food and Dietary Supplement Facilities Registration Now!
This was not mentioned in the recent webinar but it is time to renew ALL food facility registrations. This includes registrations of dietary supplement facilities.  All facilities must register between October 1^st and December 31^st of each even numbered year.  So, it is time for all food facilities both domestic and foreign to  re-register.  Online registration can be completed by following the login link on this page: http://tinyurl.com/kpb4nkj   To download forms for registration by mail, visit http://tinyurl.com/momm97g.

It is my hope that you will find these occasional updates helpful.  If so, you may subscribe to the email newsletter version by visiting http://eepurl.com/Imbjv  I send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time. 

As always, my colleagues and I would be please to help you with product labeling, facility registration or other FDA compliance questions.  Contact us today by replying to this post.

All the best to you!
Evelyn & Associates

www.FDALabels.com 

www.BioTransApp.com

Adverse Event Webinar and Other Useful Information for the Dietary Supplement Industry

Here’s hoping that the first month of 2013 has been a good one for you!  Thanks to our many valued clients, the year is off to a good start for our team. Our goal is to help your company comply with applicable FDA regulations. Accordingly, the team at FDALabels.com and Bioscience Translation & Application try to bring useful information to our clients.  Today we have several things for you:

1. A Free Webinar from Natural Products Insider on Adverse Event Reporting for the Dietary Supplement Industry is set for February 5^th.  This is a very important topic for every company that has its name on a dietary supplement product able. You can visit the following webpage for more information and a link to registration. http://www.naturalproductsinsider.com/articles/2013/01/keeping-aer-requirements-in-focus.aspx
2. More free information for Dietary Supplement companies can be found at http://www.sidiworkgroup.com/. The Standardized Information on Dietary Ingredients (SIDI) Working Group is an association of trade groups that has put together very helpful information on complying with FDA regulations.  The home page (link provided above) has a new publication on how to ‘qualify’ your ingredient or product supplier. Supplier qualification programs are necessary so that you can determine how reliable the supplier is likely to be and whether or not you will get the ingredients or final product you have specified. You can also find links to sample certificates of analysis and  product information data sheets.  It is important to have and know how to use this information for each ingredient used in your products.  The site also includes other useful information on their FAQ page.
3. Thursday, January 31, 2013 is the deadline for registering any facilities that warehouse or manufacture dietary supplements and foods.  ALL facilities MUST re-register by the 31^st unless your original registration was after October 2012.  Visit this site to register: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/default.htm.  FDA has provided some additional information on this topic:

Now Available: New FAQs Concerning Food Facility Registration

Please note the addition of two new FAQs concerning the renewal process:

IC.3.26 I do not have the Food Facility Registration PIN number that is required to access my registration in the online registration system, and therefore I am unable to renew my registration. What steps should I take?
Due to certain confidentiality constraints and the amount of time it takes the Agency to process PIN requests, the Agency is no longer able to fulfill PIN requests for registration renewals for the 2012 renewal period. If a facility is unable to renew its existing registration by January 31, 2013 because it does not have its PIN number, the facility may create a new registration by January 31, 2013 in order to be registered in accordance with section 415 of the FD&C Act.

IC.3.27 If I create a new registration, will I retain my compliance history or shipping history associated with my facility?
Some facilities may create new registrations rather than renew existing registrations because they no longer have the PIN numbers that are needed to access their existing registrations in the online registration system. For such a facility, the Agency does not anticipate a loss of compliance history or shipping history, provided that the facility’s new registration includes the same information such as facility name and facility address.

Please see the FSMA Registration page for additional resources.

It is our sincere hope that you will find this information helpful. Please feel free to forward this email to others who may be interested and please always contact us with any questions you may have.Visit our websites: www.BioTransApp.com and www.FDALabels.com to learn more about our services.  You may also reply to this post to be added to our newsletter distribution list.

Regards,

Evelyn

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

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