Waiting on FDA

Hello!

I hope that 2016 is off to a good start for you and your business and that you are looking forward to great new things!  While we look forward to seeing what 2016 will bring, many industries continue to wait for action from FDA.  I have listed just a few topics that various industry sectors hope to have clarified in 2016 below.

Foods

It has been two years since FDA proposed dramatic changes to nutrition labeling regulations (http://tinyurl.com/jjvls5q) .  Will the final rule require that ‘Added Sugars’ be listed in the nutrition facts box as originally proposed?  Industry has objected to this particularly since the amount of sugar added to jams, applesauce, etc. can vary with the inherent sweetness of the fruit. Since there is no lab test that can distinguish between naturally-occurring and added sugars, it is difficult to understand how FDA, which prides itself on being a science based organization, can ensure compliance with this rule.

Restaurant Menu Labeling: The publication of the final rules for calorie declarations on restaurant menus was delayed in 2013 and then in 2015 the compliance date for this regulation was delayed by one year to December of 2016.  Will chain restaurants really be required to post caloric values on their menus and menu boards?  While seemingly simple, there are genuine challenges with complying with this rule.  First, the accuracy required by the regulation could be tough to meet since even though restaurants are careful about portioning, there is variation.  Second, the regulation requires chain restaurants to list the calories on alcoholic beverages but the wine, beer and spirits industries are not required to provide calorie information. How is a restaurant supposed to comply? (See more on the rule: http://tinyurl.com/j7vwkgo.)

Pet Foods: In 2007 Congress mandated that FDA take over regulation of pet food.  Since that time FDA has been working with State pet and animal food regulators to come up with ingredient definitions that would meet FDA criteria.  As that progresses, FDA’s Center or Veterinary Medicine is scheduled to publish draft guidance documents that pertain to the pet food industry:

Animal Food Current Good Manufacturing Practices

Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

Human Food By-Products for Use as Animal Food

Dietary Supplements

It has been four and a half years since the first draft of the proposed guidance on New Dietary Ingredients was published (http://tinyurl.com/jtuqe4r) .  In 2013 FDA has proposed that the final rule would be published in 2014.  We are still waiting but it could be published any day!

Over the Counter Drugs

The FDA monograph that covers hand sanitizers and antibacterial soaps and body washes has been tentative since 1994.  In 2010 a lawsuit was filed to try to force FDA to finalize the monograph.  In December of 2013, FDA published a proposed rule stating that there was not sufficient data to support the safety of these products and that additional data on both safety and clinical benefit was required (http://tinyurl.com/z26bgs4).  The comment period closed in June of 2014 but no final rule has been issued.

Homeopathics

Both the FDA and FTC held hearings in 2015 looking into the regulation of homeopathic medicines.  The tone of these hearings made it very clear that both agencies view homeopathic products as quackery and would like to change the regulatory framework for homeopathic products.  Under the current policy, homeopathic products that comply with the Homeopathic Pharmacopoeia of the United States (HPUS) may be marketed in the US.  Unfortunately, some companies have introduced products that do not comply with HPUS to the market.  It seems that this is due, at least in part, to FDA’s complete failure to enforce the current regulations that apply to homoepathics.  This industry is waiting to see whether it will have a place in the US marketplace.

Cosmetics

Will the voluntary cosmetic registration and GMP program become mandatory? For years there have been bills introduced in Congress to more tightly regulate the cosmetic industry.  Discussions on Cosmetic Safety Legislation between the FDA and the cosmetic industry broke down in 2014 (http://tinyurl.com/hkmzhg7). Will we see fundamental changes to the way cosmetics are regulated in 2016?

It can be difficult to keep up with all the possible regulatory changes that can affect your day to day operations.  My associates and I work hard to stay abreast of FDA regulations, policies and related issues so we can help you stay compliant. Contact us with your questions and we’ll do our best to keep you up to date on FDA’s activities.

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.

Regards,

Evelyn & Associates
www.FDALabels.com
www.BioTransApp.com

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 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.

FDA's Agenda for 2011

Hello!!

I hope that the first 2 months of 2011 are going well for you and your business.  The information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. 

The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require that government agencies publish an inventory of rulemaking actions under development semi-annually so that we, the public, may be aware of and comment on the actions proposed on our behalf. (Not sure whether to grin or grimace here but that’s the story.)

There is something for everyone here.  FDA has been working since the 1960’s to update the monographs that regulate over the counter drugs—many of those remain on the agenda for 2011. In 2010 the agency proposed drastic changes to the process for medical device approvals and more ideas are noted on the agenda below.  Other highlights include upcoming rules on food labeling, infant formula GMPs, pet food labeling, and the use of cattle-derived ingredients in cosmetics as well as proposed rules affecting prescription drugs and biologics. New areas of FDA regulation—restaurant menus and tobacco products also made the agency’s ‘to do’ list.  The dietary supplement sector only makes the list for long term actions.

I have rearranged the agenda into product areas for your convenience.  To view the list as originally published visit http://www.gpo.gov/fdsys/ and search the Federal Register, Vol. 75, No. 243, December 20, 2010, p.79765-75767. The numbers preceding each listing are the sequence number and can be used to find more information about each rule when you visit the Federal Register. 

I would be happy to address questions you submit about these topics in future updates.  You may read past updates here on our blog, Bioscience FDA Update (http://biotransapp.blogspot.com/) . You are also invited to leave comments.

 

Food Pre-Rule Stage

311 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution

Food Proposed Rule Stage

328 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines 

329 Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants

Food Final Rule Stage

338 Use of Materials Derived From Cattle in Human Food and Cosmetics

339 Label Requirement for Food That Has Been Refused Admission Into the United States

Food Long Term Actions

355 Produce Safety Regulation .

356 Modernization of the Current Food Good Manufacturing Practices Regulation

Infant Formula Final Rule Stage

333 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements;

Records and Reports; and Quality Factors 

Dietary Supplement Long Term Actions

340 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements

Pet Food and Animal Feed Proposed Rule Stage

318 Import Tolerances for Residues of Unapproved New Animal Drugs in Food

320 Pet Food Labeling Requirements

321 Process Controls for Animal Feed Ingredients and Mixed Animal Feed

Cosmetic Final Rule Stage

338 Use of Materials Derived From Cattle in Human Food and Cosmetics

Over the Counter Drug Proposed Rule Stage

313 Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products

314 Over-the-Counter (OTC) Drug Review—Internal Analgesic Products

315 Over-the-Counter (OTC) Drug Review—Laxative Drug Products

316 Over-the-Counter (OTC) Drug Review—Sunscreen Products

317 Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products

322 Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products

Over the Counter Drug Final Rule Stage

334 Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products

335 Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products

336 Over-the-Counter (OTC) Drug Review—External Analgesic Products

337 Over-the-Counter (OTC) Drug Review—Skin Protectant Products

Over the Counter Drug Long Term Action

341 Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products

342 Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use

343 Over-the-Counter (OTC) Drug Review—Ophthalmic Products

344 Over-the-Counter (OTC) Drug Review—Oral Health Care Products

345 Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products

346 Over-the-Counter (OTC) Drug Review—Weight Control Product

347 Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products

348 Over-the-Counter (OTC) Drug Review—Antacid Products

349 Over-the-Counter (OTC) Drug Review—Skin Bleaching Products

350 Over-the-Counter (OTC) Drug Review—Stimulant Drug Products

351 Over-the-Counter (OTC) Drug Review—Antidiarrheal Drug Products

352 Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products

353 Over-the-Counter (OTC) Drug Review—Certain Category II Active Ingredients

Medical Device Proposed Rule Stage

319 Laser Products; Amendment to Performance Standard

324 Unique Device Identification

327 General Hospital and Personal Use Devices: Designation of Special Controls for Infusion Pumps

Medical Device Final Rule Stage

331 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements

Tobacco Product Proposed Rule Stage

325 Cigars Subject to the Family Smoking Prevention and Tobacco Control Act

326 Cigarette Warning Label Statements

Prescription Drug & Biologics Proposed Rule Stage

312 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 

323 Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products

Prescription Drug & Biologics Final Rule Stage

330 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products

332 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and

Lactation Labeling

Prescription Drug & Biologics Long-Term Actions

354 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and

Administrative Procedures.