Liquid and Semi-solid Foods and Dietary Supplements

On March 3, 2011 FDA published a final rule that amended 21CFR 113, which regulates ‘thermally processed low acid canned foods in hermetically sealed containers” to allow the use of ‘temperature indicator devices’ other than mercury filled glass thermometers.  So why am I telling you about this?  Partly because what the agency calls ‘canned foods’, which brings to mind metal containers and possibly glass jars, also refers to other aseptically processed foods and beverages. But I tell you about this mostly because this modernization from mercury filled glass thermometers is not the agency’s only recent alertness to this general sector of regulations. You see, the sister regulations for ‘thermally processed low acid canned foods’ are regulations covering the production of ‘acidified foods’-- foods which are not aseptically processed because their pH is low enough to prevent spoilage.

So what?  Well, you and I and FDA have noticed many more liquid dietary supplements in the marketplace.  Most contain acid ingredients and therefore are acidified foods. However, not all manufacturers comply with the regulations of 21CFR114, which require that they register their facilities as acid food producers and file the processes by which they assure that the product will not spoil and cause public harm. This registration is separate from the more generic food facility registration. I wrote about this once before in November of 2010 but I am raising the issue again because I continue to see liquid dietary supplements that have acidic components added to them but whose processes have not be filed with FDA.  Because this regulation is important for ensuring the safety of public health, any violation could cause your company to have to cease production until FDA approves your process and your entire Good Manufacturing Practices (GMP) program. 

I am also concerned about these sister regulations because I have seen a number of liquid ‘alkalinizing’ products on the market—they too would fall under one of these sets of regulations.  The guidance documents for these regulations are really hard to find on the FDA website and an FDA staffer in the office of Low Acid Canned Foods agreed that the regulations are difficult to understand; none the less, if you are producing a liquid or semi-solid product that is preserved in any way, you probably need to pay attention to this. 

If you have any doubt about which regulations apply to your products, contact us by leaving a comment. We are here help.

If you know what regulations apply to your product but need help complying with them—let us know.

Identity & Quality Testing for Dietary Supplement GMP Compliance

I hope that you have been well.  The FDA remains busy and last month I attended a conference that included a session on FDA enforcement and compliance for dietary supplements.  The speakers included Jennifer Thomas, acting director, Office of Compliance, CFSAN, US FDA; Ralph Tyler, chief counsel, Office of Compliance, US FDA and Eugene Thirolf, JD, director, The Office of Consumer Litigation, US Department of Justice, whose office prosecutes cases developed by FDA.

Two very interesting comments were made by Ms. Thomas:  First she noted that FDA plans to bring enforcement activities against dietary supplement manufacturers who use aseptic processing methods but are not properly registered.  This means companies that make liquid and gel form supplements in hermetically sealed containers.  Such operations must be registered with FDA’s office for Low-Acid and Acidified Canned Foods (http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm).  The name of this office may have lead many such producers to think the regulations did not pertain to them.  We have recently helped a company file the proper paperwork and we can help you too if needed.

The second very interesting comment by Ms. Thomas was, “…and don’t even think about using the word antioxidant on the label.”  During the question and answer period I asked Ms. Thomas what that comment meant.  She admitted to using a bit of hyperbole but went on to explain that FDA is adamant that only Vitamins A, C & E and the mineral Selenium (ACES) are antioxidants and that the agency would be cracking down on antioxidant claims used for other nutrients. Many of you have had conversations with me on this very topic.  I think it will literally take an act of Congress to get nutrients other than ACES recognized as antioxidants—so write your Congressmen!

My assistants and I continue to monitor FDA warning letters—many recent ones cite dietary supplement companies for failing to do testing to confirm the identity of the ingredients they are using. Don’t let this happen to you. To learn about identity testing you may wish to ‘attend’ the free webinar from Natural Product Insider:

Establishing Identity and Quality Testing Programs for Compliance with the Dietary Supplement cGMPs

Tuesday, December 14, 2010 at 2:00 PM EST

Companies that manufacture and distributed dietary supplements in the U.S. must now comply with final FDA current good manufacturing practices (cGMPs) related to the identity, purity, strength and composition of products. However, FDA’s initial inspections have found serious problems related to testing and documentation. During this Webinar, learn from the experts on how to improve approaches to identity and quality testing for GMP compliance. FDA’s Carl Reynolds will discuss component regulatory specifications and provide an overview of FDA expectation regarding this aspect of cGMP compliance; Frank Jaksch will discuss the importance of authenticated reference standards for identity testing; and Cynthia Kradjel will discuss how to develop FTNIR methods that are fit for purpose.

http://event.on24.com/eventRegistration/prereg/register.jsp?eventid=265144&sessionid=1&key=32B03820DD47F2A1BFC21B8C8FD289DA

As the end of year approaches we at Bioscience Translation & Application stand ready to help you meet your 2010 project goals.  Contact us today for help with FDA compliance questions on foods, dietary supplements, cosmetics and over the counter drugs. Visit us at www.BioTransApp.com.