Coming soon to a restaurant near you

Menu Labeling Coming to a Restaurant Near You

Many of you know that six months from now, as of December 1, 2015, any restaurant or “similar retail food establishments” (SRFEs) that are part of a chain with 20 or more locations must comply with the new menu labeling regulations.  These regulations require that calorie content be displayed along with pricing on all menus and menu boards for standard menu items as well as on any “food on display” as in restaurants that allow the customer to pick and choose from a range of ingredients such as sandwich or burrito fillings as they direct the assembly of their meal.  Additional nutrition information (fat, carbohydrate, protein, cholesterol, sodium, etc.) must be available upon request. Similar regulations are also coming into effect for vending machines.

FDA wrote these regulations as a result of the passage of the Patient Protection and Affordable Care Act of 2010. The regulations identify the businesses subject to these rules as

1.      Retail establishments that sell “restaurant type food” that is meant to be eaten immediately or taken away for immediate consumption.  This includes concession stands, self-serve salad or hot food bars in grocery stores and all kinds of cafes serving food.

2.      They are part of a chain with 20 or more fixed locations (food trucks do not count).

3.      The covered businesses do business under the same name or as part of the same parent entity, including slight variations in the name.

4.      They offer substantially the same menu items (even with name variations) that use the same general recipe and are prepared in substantially the same way with substantially the same ingredients.

It is important to note that restaurants and SRFEs do not have to provide calorie/nutrition information on items that the patron customizes or for daily specials and condiments.

One of the most interesting requirements of the regulation is that alcoholic beverages that appear on a menu or menu board are included even though they are not otherwise subject to calorie labeling. Beers and other alcoholic beverages may voluntarily list nutritional information on their labels but I have been told by industry insiders many brewers do not even accurately know the amount of alcohol in their products let alone what the calorie content is. (FYI alcohol provides 7 calories per gram—almost as much as fat.).

It is also interesting that states or other localities (cities, counties) may petition the FDA to be exempt from the Federal preemption to their local menu labeling regulations.  Some localities require menu labeling even for establishments with fewer than 20 locations.  In a recent webinar (March 2015) on the topic FDA noted that they had already received a petition for exemption from preemption from the City of Philadelphia.  The regulations also allow for petitions from companies with fewer than 20 that wish to be covered under the regulations and the accompanying inspections of their data. The voluntary registration also allows the restaurants to be subject to FDA’s regulations rather than to local menu labeling regulations.

Speaking of data, the regulations require that the nutrition information provided be accurate.  They also require  a statement certifying that the information contained in the nutrient analysis is complete and accurate  The statement must be signed by signed and dated by a “responsible individual” that is employed at the restaurant (or SRFE),  corporate headquarters or parent entity.  The regulations also require a statement signed and dated by a “responsible individual” employed at the restaurant certifying that the restaurant has taken reasonable steps to ensure that the preparation and amount of food provided conforms to the factors used to determine the nutritional information. In the case of violations fo the requirement to be accurate, the FD&C Act along with the Park Doctrine allow FDA to take enforcement action against the signers of those statements.  How’s that for added pressure for restaurant managers?

The nutritional data can be obtained from nutrient databases, cookbooks, ingredient nutrition facts labels, lab analyses or a combination of these.  Based on my experience working in the food industry, it will be important to have this data checked and double checked.  I also recommend carrying out laboratory analyses on at least a sampling of menu items to check that cookbook and database values enabled accurate calculations.

This brief post cannot begin to touch upon all the requirements and interpretations of the rule in the 104 page Federal Register Notice that was published December 1, 2014 so contact us with any questions you have on the topic.

As always, we hope you find these occasional updates interesting. If so, you may 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. Please post any questions you may have.  My associates and I stand ready to help you with your FDA regulatory issues.

All the best to you!
Evelyn & Associates
www.FDALabels.com
www.BioTransApp.com

FDA Update Purchasing Controls

Last week I attended a meeting with FDA staff from the Denver District Office.  The meeting was an annual update from FDA addressed to the members of the Rocky Mountain Regulatory Affairs Society.  Since most of the members work with medical devices, the speakers from FDA focused on that industry sector and in particular talked about Purchasing Control Regulations since failure to comply with them results in a large number of failed inspections, warning letters and product recalls each year. The term “Purchasing Controls” is only used in the regulations for medical devices but the language of these regulations are informative for dietary supplement, food and cosmetic companies as well. 

The regulations covering good manufacturing practices (GMPs) for dietary supplements commonly use the phrase, “ensure that the [product, components, labels and packaging] are consistent with your purchase order”.  The GMP regulations for foods and the GMP guidance for cosmetics both refer to specifications for ingredients.  Since it is impossible to consistently make quality products unless you have ingredients of consistent quality, it is imperative that your purchasing department have detailed information about the requirements for each ingredient or component used in your product.  In other words, purchasing needs detailed ingredient/component specifications. 

Let’s take a brief look at the medical device purchasing control regulations to learn more:

21 CFR 820.50(b) states, “Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services…”

This could mean that the herbs you purchase must be accompanied by chromatograms that document the amounts of key phytochemical components.  It may mean that you must list a range for the required viscosity of certain oils to ensure that your cosmetic will have the right thickness.  In the case of a food ingredient such as cayenne pepper, it may be important to define the acceptable Scoville Heat Units so that the final product will live up to your label claims of mild, medium and hellfire.

21 CFR 820.50(b) continues, “Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.

This is a very important consideration for companies that are using contract manufacturers.  Your contract with your manufacturer should explicitly define not only which ingredients may be substituted but what substitutions are acceptable and that you are to be notified when the manufacturer finds it necessary to make any change to your product.

As specified in the device regulation, the best way to ensure that you always get quality ingredients and services is to first set requirements/specifications for your ingredients, components and service providers and then evaluate their ability to meet your requirements before you contract with them. If your company has purchasing controls that are followed and followed up on by the quality and manufacturing departments it is far more likely that the products, components, labels, etc. will be consistent with your purchase order and meet your specifications.  That in turn will please your customers!

I started my consulting business in 2001 after 15 years working in FDA-regulated industry.  Since that time my colleagues and I have served hundreds of dietary supplement, food, cosmetic and device companies from around the globe.  My colleagues and I are ready to help you determine which FDA regulations apply to your product and what you need to do to comply with them. Contact us today by replying to this message.

As always, we hope you find these occasional updates interesting. If so, you may 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. Please post any questions you may have.  My associates and I stand ready to help you with your FDA regulatory issues.

All the best to you!
Evelyn & Associates
www.FDALabels.com
www.BioTransApp.com

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.

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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

What's not to like on Facebook? FDA's View

Sometimes FDA and other government agencies seem to be a bit behind the times but just last week FDA published the 19^th warning letter to mention Facebook.  Some of these letters from the past three years have also cited Twitter and Tumblr as sources of violative claims.  While these letters were primarily directed at dietary supplement companies, food, cosmetic and even drug companies can easily run afoul of FDA regulations on social media sites.

The most recent warning letter to mention Facebook, which was sent to Zarbee’s Inc. of Draper, UT. not only cites the company’s own Facebook postings but notes that “Zarbees “liked” the following comment...” and goes on to quote from customer posts noting how well the products worked for coughs, insomnia and other ailments.   In 2012 FDA had disliked the like that AMARC Enterprises, Inc. of El Cajon, CA gave to one of its customer’s posts about using their dietary supplement product for cancer.

The concept that testimonials presented on company websites and in other marketing materials are claims that are subject to regulatory scrutiny is not new.. In 2009 the Federal Trade Commission (FTC) issued a guidance document on testimonials and endorsements in advertising http://tinyurl.com/kdxnoqa  noting that they, like all marketing claims must be truthful, not misleading and supported by data.  FDA expands requirements for endorsements and testimonials to require that they comply with regulations on allowable claims.

All companies like positive comments and testimonials from customers.  While consumer comments are not a new phenomenon, the consumer’s ability to publish their comments to the world on social media sites is new.  So what is a company to do when a happy customer posts something that makes a claim that violates the regulations governing the compliant marking of their product?  

Several of the Facebook warning letters included this note from FDA,

“We advise you review all the information on your websites, including testimonials, social media websites (e.g., Facebook and Twitter), product labels, and other labeling and promotional materials for your products to ensure the claims you make are not in violation of the FD&C Act. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.”

The last sentence makes it clear: Companies must closely monitor their social media for compliance with FDA regulations. If a post about a product goes beyond what is allowed by regulation, the posts must be deleted or edited to become compliant.

·        If you are a dietary supplement company and a customer posts that your product cured an ailment or relieved pain; your product just became an unapproved new drug subject to FDA enforcement.

·        If you are a cosmetic company and a happy customer states that your oil healed their skin condition, that oil just became an unapproved new drug subject to FDA enforcement.

·        If you are selling an OTC drug and a customer posts about a use that is not covered in the approved labeling of your product, you are also subject to FDA enforcement action.

My colleagues and I can help you stay out of trouble by reviewing or monitoring your website and social media posts, as well as your product labels and brochures for FDA compliance.  Contact us with your questions.

It is my hope that you will find these occasional updates interesting. If so, you may 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. Please post any questions you may have.  My associates and I stand ready to help you with your FDA regulatory issues.

All the best to you!

Evelyn & Associates

www.FDALabels.com 

www.BioTransApp.com