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  Once the GRAS status is so rescinded, partially hydrogenated oils would not be allowed in food products sold in the US.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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Steps to Successful Product Formulation

Hello!

The trade magazine, Natural Products Insider (NPI), recently published a slide show entitled, “Formulating Successful Products in Six Steps”.  While the presentation focuses on the development of dietary supplement products, similar considerations are helpful for cosmetic and food products as well.

The steps were written for brand owners using contract manufacturers but also apply to companies doing in-house manufacturing.

The first step cited was to set finished product specifications.  Specifications define the parameters for identity, purity, strength, and composition for the product.  Good Manufacturing Practices require setting specifications to guide the manufacture of the product.  You must set product specifications and also have procedures in place to verify that the product is being manufactured to those specifications.   

The slide show contemplates a scenario where the brand owner seeks help from the contract manufacturer’s formulator.  It is important that your contract with your manufacturer clearly states who owns the formula if you do use that service. 

According to the NPI slides the minimum specifications include but are not limited to information to:

1.      Define the purpose or benefit of the product.

2.      Determine the form of the product -- for supplements is it tablets, capsules, a powder?  For cosmetics it is a gel, lotion or cream?

3.      Determine what ingredients will be used. 

a.      I’d like to add that it is important to think about the availability of the ingredient and understand whether there are any seasonal pressures on the ingredient availability.  If you have an ingredient that is in short supply during certain seasons, consider formulating with a mixture of the preferred ingredient and its best substitute to stretch the supply and avoid sourcing issues.

b.      It is also very important to write specifications for whether ingredient substitutions may be made.  It is also important to clearly define what ingredients would be acceptable substitutions since these changes to the formulation can affect manufacturing, product quality as well as labeling and claims.

4.      Plan in advance which countries the product will be sold in and be aware of regulations or restrictions that affect which ingredients may be used.

5.      Determine whether some ingredients will be required or prohibited. Desired label claims such as ‘natural’, ‘low fat’, ‘vegetarian’ or ‘gluten free’.  Such claims will affect costs and may affect which manufacturers will be able to make your product. The claims that may appear on the final product label are determined by the formulation.

The complete slide show and all six steps can be viewed at http://www.naturalproductsinsider.com/galleries/2013/04/slide-show-successful-formulations.aspx?cmpid=EM.

My associates and I can help you write specifications for your product.  We can also help you research the regulatory status of proposed ingredients and review product labels and marketing materials for compliance with FDA regulations.  We welcome your questions.

I hope that you will find this information helpful. Please use this link http://eepurl.com/Imbjv to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We 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.

Evelyn and Associates

Bioscience Translation & Application                 www.BioTransApp.com

FDALabels.com                                                    www.FDALabels.com