FDA's New View of Partially Hydrogenated Oils

On November 7, 2013 FDA published a ‘Request for Comments and for Scientific Data and Information’ regarding the use of partially hydrogenated oils in foods.  The FDA has reviewed the scientific data and has determined that there is no longer scientific consensus on the safety of partially hydrogenated oils due to the presence of artificial trans fats in those oils.  (Note that fully hydrogenated oils do not contain trans fats.)  Since there is not a consensus on the safety of partially hydrogenated oils, FDA is poised to declare that these oils as no longer generally regarded as safe (GRAS).  Once the GRAS status is so rescinded, partially hydrogenated oils would not be allowed in food products sold in the US.  

Partially hydrogenated oils were invented in the 1930’s and have been considered GRAS since they were in common use prior to the 1958 Food Additives Amendment to the FD&C Act.  It was even thought that partially hydrogenated vegetable oils were ‘healthier’ than dairy and other animal fats that they replaced in many products; particularly baked goods.

Oils are partially hydrogenated to increase their solidity and melting temperature and to increase the shelf life of the products they are used in.  These effects are all gained when the double bonds in unsaturated vegetable oils are converted into single bonds by the addition of hydrogen.  Partially hydrogenated oils can result in some trans fat bond conformations that are not readily broken down by the body’s enzymes, leading to build up of these fats in the body. 

When FDA began requiring that the amounts of trans fatty acids be declared in the nutrition facts panel in 2006, many food products were reformulated just enough to bring trans fat levels below the 0.5 gram threshold of declaration.  Many consumer groups were outraged that 0.499 grams of trans fat were required by regulation to be declared as 0 grams of trans fat and FDA has been pressured to take further steps since then.  A suit was filed in California seeking to force FDA to take steps to remove trans fat from the US food supply. 

Most of our clients don’t use trans fatty acids. However, in the course of our detailed label and ingredient reviews, we have sometimes found that ingredient suppliers were not being entirely upfront with their customers.  Some only provide nutritional information on a very small amount of their fats and oils. In doing so, they can list trans fats as zero. So what is a food-producer to do? 

      1.      Understand that it is only artificial trans fats that are harmful and they come from partially hydrogenated oils.

      2.      Always, always, ask for detailed specifications and certificates of analysis for every ingredient in your product.

      3.      Read the specifications and certificates of analysis and ask questions about anything you do not understand.

      4.      Write detailed specifications for your product that ensure that only the quality of ingredient you want is used in your product so that it will not trans fats or any other ingredient/component your customers may wish to avoid.

You can read more about FDA’s proposal to rescind the GRAS status of partially hydrogenated oils.  This link will take you to a summary aimed at consumers: http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm373925.htm .  This link will take you to the full announcement in the Federal Register: http://www.gpo.gov/fdsys/pkg/FR-2013-11-08/pdf/2013-26854.pdf.

As always, please post a comment to this blog with your questions on labeling and other FDA regulations.

Regards,

Evelyn & Colleagues
FDALabels.com                                      www.FDALbels.com
Bioscience Translation & Application    www.BioTransApp.com

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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

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.

FDA Promising Increased Scrutiny of Imports

Hello!

Trade newsletters are reporting that FDA Commissioner, Dr. Margaret Hamburg’s remarks at the Food and Drug Law Institute conference discussed her priority to respond to the increase in adulterated and misbranded imported food products.  Many of our clients have noted the increased scrutiny of products at the US border.  Products that had been successfully imported for a number of years are now being detained due to increased inspections.  Product from new importers into the US are basically guaranteed that their import will be held for inspection, which may include testing to ensure that levels of nutrients declared on labels are met as well as to determine whether the product is contaminated with bacteria or even laced with pharmaceutical compounds.

At the same conference, FDA Associate Commissioner for the Office of Regulatory Affairs, Michael Chappell, noted that in 2010 FDA has already issued a record number of warning letters to companies importing, manufacturing and distributing FDA-regulated products.  Many of these have gone to food, dietary supplement and cosmetic companies. The importance of FDA inspections is apparent since, as stated by FDA Chief Counsel, Ralph Tyler, 25% of the US economy is comprised of FDA-regulated products.

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At Bioscience Translation & Application your success is our success and we work with our clients to ensure compliance with FDA regulations.  Contact us for product development, labeling and claim substantiation help with your FDA-regulated products or visit us at www. BioTransApp.com