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

Labels as Tables of Contents

Greetings!

Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc (http://www.nosco.com/), presented information on packaging, labeling and compliance.  I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that can guide an inspection of your manufacturing facility.  For instance, the net contents statement clues an inspector in on the type of equipment they will be reviewing: liquid or powder fill, tableting or encapsulation.  Whether the product is a food, drug, cosmetic or dietary supplement, the statement of identity, along with product claims, determines which regulations apply.  Claims used on the product label also convey the amount and type of data that should be on file to support the claims so that you can comply with the requirement that all claims be truthful, not misleading and supported by data.

If the product is a dietary supplement, the supplement facts box outlines the manufacturing process.  If the facts box lists a proprietary blend, then the standard operating procedure or SOP should reflect a blending step.  The supplement facts box can provide a list of herbs that may require identity testing or that may need to be the subject of a new dietary ingredient notification. Nutrition Facts boxes on foods or Drug Facts boxes on over the counter drug products guide inspectors to look for data to support the values declared or to demonstrate adherence to applicable monographs.The ingredient list is another place when an inspector may look for ingredients that may not be permitted in products marketed in the United States.

Finally, the signature line listing the name and place of business of the company introducing the product into the marketplace, assigns responsibility for compliance with labeling regulations, good manufacturing practices and adverse event reporting system. In the event an inspector finds something amiss, the signature line names the company that will get the 483 or possible warning letter.

With so much riding on the information listed on your product label, don’t ignore the importance of ensuring that your labeling is correct and complies with FDA regulations.   Visit our websites, www.BioTransApp.com or www.FDAlabels.com for more information on labeling or other FDA compliance issues.  This blog discusses issues pertinent to FDA-regulated industries. Post a comment to let us know if you would like to subscribe to occasional email updates targeted to your industry sector.


Copyright 2011 Bioscience Translation & Application

Nutrition Labeling of Major Cuts of Meat Required by January 2012

Hello!

I know the name of this blog is FDA Update but my team provides USDA regulatory help from time to time and that agency has caught my attention today.    My favorite blog, FDA Law Blog by Hyman Phelps & McNamara posted about the new USDA requirement for nutrition labeling on major cuts of meat here: FDA Law Blog USDA Nutrition Labeling.  It got me wondering what my local, independent butcher was doing to comply, so I called him and initially ruined his day.  I felt so bad!  I ended up researching the rule more thoroughly and found that USDA's Food Safety and Information Service (FSIS) has prepared posters that butcher and other meat retailers can print and display to comply with the labeling rule. I called my butcher back and told him the good news sent him the posters.  So, here for your convenience are links to the FSIS nutrition labeling posters: Beef & Veal, Chicken & Turkey and Pork & Lamb.  The posters are high resolution PDFs that can be enlarged as needed.  I suggest that butchers and other small business meat retailers go to their local print shop and get large laminated versions that can be displayed in the shop.  

There are other requirements for posting nutrition information for ground products.  Many small business owners are exempt but consumers may seek the information. For a list of other information on this new rule visit the this page at the FSIS website. 


You can also visit the Bioscience Translation & Application  website atwww.BioTransApp.com.

FDA Delays Publication of Menu Labeling Rules

Well, March 23, 2011, the statutory deadline for FDA to publish proposed rules on how to implement the nutrition labeling provisions of the Health Care Reform Act, has come and gone with no rules.  Nation’s Restaurant News reports that in a statement FDA said, ““We expect only a short delay in getting these documents out, and it is a reflection of the complexity of this issue, but most important an indication that the FDA is willing to work with all interested parties to ensure the best policy is presented,” the FDA said. “We are committed to helping the public get clear and simple information about the food they buy and using a common sense approach to implement this law."

Read the entire article at Restaurant News. 

It will be important for the restaurant industry to review the eventual rule and provide comments to try to shape the final rule.  Contact us if you need help submitting comments or for information on how to tackle providing nutrition information on your menus. (You can reach each us by commenting on this blog or by visiting the Bioscience website)

It will be some time before we know whether nutrition information on menus and vending machines will help with America’s obesity problem.  Chances are slim that it will—food and diet are very personal topics and American’s eating habits are also affected by our busy lifestyles.  We expect our bodies to function on whatever we give them without the type of ‘preventive maintenance’ that we do on our cars. Of course, we get information about how to prevent breakdowns of our cars but most information about how to prevent ‘breakdown’ of our bodies with food is considered to be making prohibited claims.  What is the food industry to do?  My answer is: Watch the nutritional genomics literature and lobby congress to work with FDA on ways to discuss the findings with consumers.  Learn more about nutritional genomics here: Nutrigenomics.