Manual on GMPs & SOPs

Hello!

We have become aware of a new manual from the American Herbal Products Association (AHPA) that provides guidance as well as templates for preparing Standard Operating Procedures (SOPs) for compliance with Dietary Supplement Good Manufacturing Practices (GMPs).  Having SOPs is an important part of complying with FDA’s GMP regulations, which are effective for even the smallest companies this June.  According to our FDA contacts, inspections of dietary supplement companies will begin in earnest.

You can learn more about the manual by visiting the AHPA site at http://ahpa.org/Default.aspx?tabid=69&aId=593&zId=1 .

Our goal at Bioscience Translation & Application is to further our clients’’ success while helping them ensure they are compliant with applicable FDA regulations.  Contact us for help with SOPs, GMPs or other FDA regulations.

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

New Patent Marking Ruling

Hello!

I wanted to share with you another interesting post by Kurt Karst at FDALawBlog.com.  This one discusses a recent court ruling on patents that has implications for FDA regulated industries.  The decision, in part, states

“Whoever marks upon, or affixes to, or uses in advertising in connection with any unpatented article the word "patent" or any word or number importing the same is patented, for the purpose of deceiving the public; or Whoever marks upon, or affixes to, or uses in advertising in connection with any article the words "patent applied for," "patent pending," or any word importing that an application for patent has been made, when no application for patent has been made, or if made, is not pending, for the purpose of deceiving the public - Shall be fined not more than $500 for every such offense.”

Each offense is then defined as each article that includes the false patent claim.  The ruling goes on to state, “Any person may sue for the penalty, in which event one-half shall go to the person suing and the other to the use of the United States.”  As a result of this, several law suits have been filed.

Many of our clients are surprised by the detailed regulations governing product labeling.  This is yet another label detail to bear in mind.  We stand ready to help you with your labeling and other FDA regulatory needs and welcome your call (303-432-1605) or email. 

To read the entire FDA Law Blog post, visit: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/03/complaint-for-false-patent-marking-have-you-received-one-if-not-you-might-soon.html

FTC Issues Letters on Omega-3 Fatty Acid Claims

The Federal Trade Commission in conjunction with the Food and Drug Administration has announced that they have issued warning letters to several companies who are making claims regarding omega 3 fatty acids and brain and vision function.  The agencies are seeking information regarding the substantiation of these claims. 

Recently, Northwest Natural Products successfully responded to a similar warning letter with the result that FTC issued a closeout letter stating that no enforcement action would be taken. In the letter, the FTC stated,

“Upon careful review of the matter, including non-public information submitted to staff, we have determined not to recommend enforcement action at this time. The factors we considered in making this determination include the very limited duration of the print advertising campaign containing the claims at issue and NNP's swift and voluntary action to modify all marketing materials for these products, including product packaging and labeling, to ensure compliance with the FTC Act. Specifically, we understand that NNP has destroyed all remaining product labels containing the claims at issue and is in the process of distributing new labels”

The letter further stated that the FTC staff “appreciates NNP' s significant cooperation in the prompt resolution of this matter.”  This example clearly shows how having appropriate documentation of all claims as well as displaying good faith by being cooperative and working to address any regulatory issues can prevent enforcement actions that could result in product seizure and severe disruptions in business. 

At Bioscience Translation & Application, we often provide our clients with information as to what risks various claims may pose.  We also remind our clients that all claims must be truthful, not misleading and substantiated by scientific data.  We at Bioscience Translation & Application are ready to evaluate your product claims and to help you gather the information required to substantiate your product claims to ensure your success  We also stand ready to help you respond to FDA letters and actions, should the need ever arise. Visit us at www.BioTransApp.com

For further information on this topic, you may view the FTC news release at http://www.ftc.gov/opa/2010/02/omega.shtm  and a discussion of it at http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/02/ftc-hones-in-on-omega3-claims-among-others.html

See the Northwest Natural Products closeout letter at http://www.ftc.gov/os/closings/091030northwestclosingletter.pdf

FDA Draft Guidance on Beverages Marketed as Dietary Supplements

As 2009 draws to a close FDA continues their ramped up enforcement activities based upon new guidance documents and letters to industry.  A draft guidance document published on December 7, 2009 lets us know that FDA is eyeing functional beverages and liquid dietary supplements for future enforcement activity. 

The full title of the draft guidance document is, “Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods” and can be found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm

FDA made some very interesting statements in this document.  First, the agency notes that there has been a growth in the marketing of dietary supplements that are packaged and labeled as beverages.  Beverages are considered ‘conventional foods’ and by definition are not dietary supplement products.   Second, the agency notes increased marketing of “beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts.”  Many of our clients have been dismayed when we have informed them that certain ingredients, that can be found in blockbuster, name brand products, are not permitted for use in their products.  The new guidance document tells us that those products’ days are numbered.

The guidance document outlines factors the agency looks at to determine whether a liquid product is a conventional beverage or a dietary supplement. 

1. Packaging – if it looks like a conventional beverage package, it may be a beverage
2. Serving size or the volume in which they are intended to be consumed.  A standard beverage serving size is one cup (8 oz)  or 240 ml
3. Product or brand name, terms such as “beverage,” “drink,” “water,” ‘juice,” or similar terms represent the product as a conventional beverage
4. Recommended conditions of use.  Products to quench thirst or to refresh would certainly be considered beverages but the agency did not elaborate on other uses that they consider related to conventional beverages.
5. Statements about the product in labeling or advertising. 

The agency has asked for comments within 60 days of the December 7^th proposed guidance.  You may submit comments to http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a62af4 .  If you would like to submit your comments anonymously, please send them to Bioscience Translation & Application and we will submit them in a consolidated document.

Dietary Supplement GMPs and 100% Identity Testing

Hello!

Many of our dietary supplement clients have struggled with complying with the Good Manufacturing Practice Regulations FDA wrote the industry.  The following link takes you to an article in The Natural Products Insider that discusses the agency’s view and includes a video of Vasilios Frankos, Ph.D., director of the division of dietary supplement programs at FDA, discussing his views on GMP implementation at Supply Side West in November.

The article discusses the concept of 100% identity testing as well as the need for written records of all procedures used for the manufacture of dietary supplements.  Read the entire article and watch the video at

http://www.naturalproductsinsider.com/news/2009/11/fdas-frankos-discusses-agencys-gmp-expectations.aspx

If you have questions regarding GMPs or any other aspect of FDA regulations, please do not hesitate to contact us.

Nutritional Genomics

Hello!

I will be speaking at the Nutritional Genomics Conference at California State Polytechnic University, Pomona CA, November 12^th – 14^th. 

What is nutritional genomics?  It is the study of the impact of diet on health through gene expression. Just as some genetic markers can indicate a person’s risk for some diseases, the emerging field of Nutritional Genomics seeks to understand whether we can learn what foods positively (or negatively) effect our health.

The ultimate goal of the conference is to use whole foods in our diet to prevent some of the catastrophic health outcomes currently overtaking our children and impacting their future health and longevity.  I will be speaking on Nutritional Genomics and the Future of Food Labeling

Click this link to learn more http://www.csupomona.edu/~nutrigenomics/conference.shtml

I would love the opportunity to meet with you if you are attending the conference or are in the greater Los Angeles area.  Please contact me to set a time to meet.