FDA Updates Its Guidance on Prior Notice of Imported Foods

By Michael J. O’Flaherty

The Food and Drug Administration (FDA) has published an updated guidance document, Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3).  This draft guidance is being distributed for comment purposes only.  Although comments on FDA guidance documents may be submitted at any time (see 21 C.F.R. § 10.115(g)(5)), to ensure that the agency considers any comment on this draft guidance before it begins work on the final version, electronic or written comments must be submitted by May 30, 2014.  79 Fed. Reg. 17,947 (Mar. 31, 2014).

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires that FDA receive prior notification of food, including animal feed, intended for import into the United States.  Advance notice of import shipments allows FDA, with the support of U.S. Customs and Border Protection (CBP), to target import inspections more effectively and help protect that nation’s food supply against terrorist acts and other public health emergencies.  Pursuant to the Food Safety Modernization Act (FSMA), FDA on May 5, 2011, published an interim final rule requiring that a person submitting a prior notice report the name of any country to which the food has been refused entry.

The draft guidance includes information related to this new requirement that a prior notice include the name of any country that has refused entry of the food.  It also addresses questions received by FDA since publication of the second edition of the guidance in May 2004.

Draft Methodological Approach for Designating High-Risk Foods — Comment Period Extended

By Michael J. O’Flaherty

The Food and Drug Administration (FDA) has published notice of a 45-day extension, until May 22, 2014, of the comment period on its Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of FSMA.  79 Fed. Reg. 16,800 (Mar. 26, 2014).  Notice of the draft guidance document originally was published in the Federal Register on February 4, 2014.

FDA is required under section 204(d)(2) of the Food Safety Modernization Act (FSMA) to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary in order rapidly and effectively to track and trace such foods during a foodborne illness outbreak or another event.  See generally Questions & Answers on Product Tracing.  FDA plans to publish a list of these high-risk foods either before or at the same time that it issues a proposed rule under section 204(d)(1) of FSMA to establish the recordkeeping requirements for the designated high-risk foods.

The draft methodological approach is based on an evaluation of chemical and microbial hazards combined with foods (i.e. food-hazard pairs) using criteria that encompass the factors required under section 204(d)(2)(A) of FSMA.  Available data for each criterion are used to determine a total risk score for each food-hazard pair.  The draft approach allows each criterion to be weighted where appropriate.  No specific foods or hazards are included in the draft methodological approach.  Although the analysis would encompass food-hazard pairs, FDA anticipates that the list would contain foods only, not food-hazard pairs.  Where multiple hazards occur for a given food, a total risk score would be determined for that food.

Some of the specific issues on which FDA is soliciting comments include:

  •         Alternative approaches for identifying high-risk foods;
  •         Whether the criteria should be weighted equally;
  •         Changes in the scoring system; and
  •         How foods should be categorized.

The comment period was extended in response to requests expressing concern that the 60-day comment period did not allow sufficient time to develop a meaningful and thoughtful response to the original notice.

Intentional Adulteration – Comment Period Extended

By Michael J. O’Flaherty

The Food and Drug Administration (FDA) has published notice of a 90-day extension, until June 30, 2014, of the comment period on its proposed rule addressing intentional adulteration of food and on an associated draft document, both published in the Federal Register on December 24, 2013 (see blog postings dated January 7, January 31, and February 21, 2014).  79 Fed. Reg.  16,251 (Mar. 25, 2014).

Under FDA’s proposed rule, entitled “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration,” a food facility would be required to have a written food defense plan that addresses significant vulnerabilities in its food production process, and then would need to identify and implement strategies to address these vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training, and maintain certain records.  The proposed rule does not apply to farms and food for animals.

The comment period on the proposed rule, and an associated draft document entitled “Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition),” was extended in response to requests that conveyed concern that the original 100-day comment period did not allow time to thoroughly analyze the proposal, due to its inherent complexity and the unique nature of food defense issues.

Food Security from the Tractor Seat

By Charles W. Stenholm

Last week’s headlines announced the arrival of higher food prices with more increases to come because of widespread drought in California and Texas.  Talk of climate change and its effect on food production in some circles has taken on a new sense of urgency.  But among all the handwringers, one common characteristic stands out.  They are all against technology.

But just as Malthus has been proven wrong time and time again because of technology and its applications by our farmers and ranchers, continued research and extension will meet the future needs of the world IF it is allowed to be developed and used.  Biotechnology and GMO’s have been, and will continue to be, vital to the world as it attempts to feed a growing population.

For example, a recent study of the poultry industry commissioned by the American Egg Board concluded that it took 32 percent less water to produce a dozen eggs today compared to 1960.  Using egg production technology of the 1960’s, it would require 78 million more hens, 1.3 million more acres of corn, and 1.8 million more acres of soybeans.  These and many other examples consistently show how technology helps conserve water, lower food costs, and improve the overall environment.

Now, I pose a simple question to those of us who are concerned about global food security: How is the world going to feed itself over the next 50 years on less land and with more expensive water?  That in and of itself poses a significant obstacle, but without continuing to challenge our best and brightest minds and allowing them to find and develop the technological solutions, I submit it will be impossible.

For all of the controversy over the nutrition title of the Farm Bill regarding spending, did any side ever stop to consider that the higher cost of food will most assuredly have a very adverse effect on those of us least able to afford what we are eating today, and that SNAP and school lunch dollars will not go as far in the future as a result?

If we deny the rest of the world the use of current and future biotechnology, they will not be able to feed themselves.   I hope we can provoke a discussion between the hunger community and the environmental community that is so opposed to GMO’s to answer a simple question:  If not with technology, how will the world feed itself?  The answer cannot be organic, albeit completely acknowledging that it is a growing and profitable market that might eventually provide for 10 percent of the world food needs of those who prefer and can afford the higher prices!

The hunger community must begin to give more sincere attention to how the world can feed itself now and in the future; step one is embracing sound science and biotechnology.

Former Congressman Charlie Stenholm represented the 17th District of Texas in the U.S. House of Representatives for 26 years. He was a member of the House Agriculture Committee throughout his career, serving as the Committee’s ranking Democrat for his last eight years in office.

“Time”-ly Tip from Dr. Doom

By Barbara J. Masters, D.V.M.

There has been a great deal of noise in the media recently about “plants running without inspection” and the significance to both the establishment and to FSIS.

It is important to remember that no operations requiring inspection shall be conducted “except under the supervision of a program employee.”  FSIS provides that supervision in a variety of ways during the plant’s approved hours of operation, either through continuous on-site inspection or by a patrol inspector who is assigned to one or more establishments within a geographic area.  With a patrol inspector, FSIS is “constructively present” at all establishments within the patrol because the inspector could appear at any individual establishment at any time.  FSIS does require that the inspector also be physically present at each establishment at least once per shift.

The question arises, what, if during the day, the establishment determines it needs to run outside of the approved hours of operation?  The establishment officials must notify FSIS as soon as they are aware they need to run overtime to make arrangements for inspection coverage.  There are certain activities that must be conducted under inspection.  The establishment should not perform these activities without reaching the inspector to have the overtime approved.  The plant should have a documented procedure for requesting overtime and make sure it is current (given the periodic inspector rotation).  The most common reason for a plant running without inspection is that it is an infrequent occurrence and the personnel simply forgot the process for notifying FSIS.  Who do we call?  What is the correct after hours number?  If the Consumer Safety Inspector is not available, who do we call next?  What is the number for that person?  Where are these numbers accessible at the plant?  FSIS maintains the phone numbers for the District Offices on the FSIS website.  The phone numbers for the in-plant inspection personnel will have to be obtained at the local level.

Additionally, many establishments do not have a clear sense of the specific activities that FSIS has outlined as requiring inspection.  FSIS Directive 12,600.2, Rev. 1 provides the specific details on the activities that require FSIS inspection presence.  For example, the obvious activities of preparing meat and poultry products for packaging or for further processing into meat or poultry food products require inspection.  The example activities include: slaughtering, boning, cutting, slicing, grinding, injecting, pumping, adding ingredients through other mechanical means, formulating, assembling, packaging or labeling meat or poultry components of meat or poultry food products.

FSIS has also defined verification activity of direct observations of its monitoring activities at CCPs as requiring inspection, as well as applying the mark of inspection.

FSIS distinguishes these activities from those which the Agency would consider as not requiring inspection (and which accordingly would not require overtime inspection services), including:

  • Receiving meat and non-meat ingredients;
  • Receiving and sorting returned goods;
  • Shipping inspected and passed products;
  • Moving products within the facility;
  • Performing sanitation procedures and monitoring procedures outlined in the SSOP;
  • Performing monitoring or verification (e.g., calibration or records review) associated with HACCP;
  • Performing corrective actions;
  • Performing pre-shipment review;
  • Cooking, drying or smoking – as long as the establishment does not conduct verification during the time period.  For example, cooking with continuous monitoring overnight, with the verification done the next morning when inspection is present.
  • Chilling as long as verification is not conducted during the time period.  For example, carcasses may be chilled overnight.  The establishment may monitor during the chilling process, but the verification would take place the next morning when inspection was present.
  • Collecting and testing samples of product.

FSIS has provided these as examples of activities that can be conducted without overtime inspection presence.  The key to the activities is that there are adequate records for inspection verification.

Why FSIS has made the differentiation for verification requiring inspection compared to other activities is not clear.  What is very clear is that products produced without “inspection” will be subject to voluntary recall if it is already in commerce.  All products will be required to be diverted into inedible rendering or denatured and sent to landfills.   Finally, FSIS can initiate a suspension of inspection without prior notice.

FSIS response to products being produced without inspection is covered in FSIS Directive 12,700.1, Rev.1.

This is a totally preventable situation!  Understand what activities require inspection during overtime.  Know who to ask and how to reach them.  Have a documented procedure for reaching them, and follow it!  If ever in doubt, reach out!

About “Dr. Doom”

Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters.  Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator.  During her rise to the Administrator’s position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations.  While in these key leadership positions at FSIS, Dr. Masters’ primary focus was on the implementation of science-based policies for the protection of public health.  Dr. Masters issued the initial Federal Register Notices for a systematic approach to humane treatment of livestock and poultry.

Dr. Masters was involved in the drafting of the training of inspection personnel on the Hazard analysis and critical control points (HACCP) and Sanitation Standard Operating Procedures (SSOP) regulations.  She was the lead of the FSIS HACCP Hotline.  In addition, Dr. Masters provided technical review for establishment’s hazard analysis, HACCP plans and supporting documentation.  She started her career at FSIS as a public health veterinarian that had responsibilities for ante-mortem inspection, sanitation inspection and all post-mortem inspection responsibilities.  She has a good understanding of what happens at the in-plant location, because she has spent many of long days working there.

FDA denies Remodulin® Citizen Petition; Treprostinil Injection ANDAs can proceed with labeling carve-out

By Tish Eggleston Pahl

Last week, FDA announced the latest in a line of decisions demonstrating the agency’s continued support for approval of generic drugs with labeling that “carves-out” information protected by a brand drug’s patents or marketing exclusivity.

Section 505(j)(2)(A)(i) of the Food, Drug and Cosmetic Act requires that an Abbreviated New Drug Application (ANDA) contain “information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved” for the brand or reference listed drug (RLD).  The Act also requires that an ANDA contain information to show that the labeling proposed for the new generic is “the same” as the labeling for the approved RLD, except for certain permitted changes such as labeling differences to reflect the different manufacturers.  Other permitted differences in labeling include “omission of an indication or other aspect of labeling protected by patent or accorded exclusivity under section 505(j)(5)(F) of the act.” 21 C.F.R. § 314.94(a)(8)(iv).  However, those labeling differences must “not render the proposed [ANDA] product less safe or effective than the listed drug for all remaining non-protected conditions of use.”  21 C.F.R. § 314.127(a)(7).

It is well-established that an ANDA applicant may carve-out patent- or exclusivity-protected labeling without violating the “same labeling” requirement.  FDA addresses carve-out issues “on a case-by-case basis depending on whether the legal and medical standards for ANDA approval are satisfied given the specific facts presented.”  FDA has generally construed these provisions liberally and approved generics with patent- or exclusivity-protected labeling carved out.  Previous decisions include carve-outs for Lyrica; Altace; Marinol; and Camptosar.  The agency’s latest decision, issued last week, involved Remodulin® (treprostinil) Injection; the carve-out decision is here.

United Therapeutics Corp. (UTC) holds the new drug application (NDA) for Remodulin®.  Remodulin® can be administered via subcutaneous infusion; it can also be administered via intravenous infusion, using one of three diluents:  Sterile Diluent for Flolan® or Sterile Diluent for Epoprostenol Sodium (collectively, “Sterile Diluent for Flolan”); Sterile Water for Injection (“sterile water”); or 0.9% Sodium Chloride Injection (“saline solution”).  UTC submitted information to FDA for listing a patent in the Orange Book for intravenous administration of Remodulin® using Sterile Diluent for Flolan.  In a citizen petition filed on October 15, 2013, UTC argued that Sterile Diluent for Flolan had safety benefits in comparison with sterile water or saline solution and that no ANDA for Remodulin® should be permitted to carve the patent-protected Sterile Diluent for Flolan information from labeling.

FDA, however, denied UTC’s petition.  The agency carefully reviewed the data UTC offered and was unconvinced that intravenous infusion of Remodulin® using Sterile Diluent for Flolan,  rather than sterile water or saline solution, protected patients from bloodstream infection.  As a result, assuming it receives final approval, a generic treprostinil drug may proceed to market without the patent-protected Sterile Diluent for Flolan® information from the Remodulin® labeling.

The Remodulin® decision and the others that have preceded it show that FDA scrutinizes any claims by the NDA holder that patent- or exclusivity- protected labeling cannot be carved out of a proposed generic’s labeling.  After careful analysis, FDA frequently finds that labeling omissions due to patent or other exclusivity will not render a generic drug less safe or effective than the RLD.

FDA Issues Statement on GRAS Determination of Senomyx

By Mark L. Itzkoff

On March 12, 2014, FDA issued an unusual statement regarding the GRAS status of a new flavor ingredient.  FDA issued the statement in response to a March 11 press release from Senomyx regarding the GRAS status of a new flavor ingredient, Sweetmyx.  FDA stated that the press release “appeared to suggest that the U.S. Food and Drug Administration (FDA) had made the GRAS determination” while the agency had not made the determination and the company had not notified FDA of its determination.   At least one news story also reported that the GRAS determination had been issued by FDA.   Senomyx has now issued a second statement clarifying the original press release and acknowledging that the GRAS determination was made by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States (FEMA).

In the agency’s statement, FDA notes that companies may make independent GRAS determinations without notifying FDA.  The agency also notes that FDA has a voluntary program (the GRAS Notification Program) whereby a company can inform FDA of its GRAS determination.  The statement also warns that when announcing GRAS determinations, “companies should not state or imply that the FDA has made a GRAS determination on their food ingredients.”

The FDA statement comes at a time when GRAS status and the GRAS Notification Program has come under strong criticism from the Pew Charitable Trusts (see our story here) and the Natural Resources Defense Council (see story here), and is the subject of a lawsuit filed by another consumer group (see story here).

U.S. Supreme Court Extends Sarbanes-Oxley Whistleblower Protection to Employees of Privately-Held Companies

By Elliot Belilos

On March 4, 2014, the U.S. Supreme Court ruled in Lawson v. FMR LLC, No. 12-3 that “whistleblower” protection under the Sarbanes-Oxley Act of 2002 extends to the employees of a public company’s private contractors and subcontractors.

The Sarbanes-Oxley Act was enacted in the wake of the Enron scandal largely to protect investors in public companies and to restore trust in financial markets.  Among other things, Sarbanes-Oxley protects “whistleblowers,” providing that: “No [public] company…or any…contractor [or] subcontractor…of such company, may discharge, demote…[or] discriminate against an employee in the terms and conditions of employment because of [whistleblowing activity].” 18 U.S.C. § 1514A (a).  There are other Sarbanes-Oxley provisions, however, that directly affect more than simply public companies, notably changes to the criminal code enhancing penalties for all mail and wire fraud.

The extent to which Sarbanes-Oxley governs private companies continues to develop.  In Lawson, the plaintiffs, former employees of a private company that contracted with publicly-traded mutual funds, alleged that their employer, FMR LLC, retaliated against them for reporting alleged fraud by an FMR client.  The district court rejected FMR’s argument that the Sarbanes-Oxley protects only employees of public companies. On appeal, a divided panel of the First Circuit reversed, finding that while FMR was a contractor under § 1514A, that provision only protected public company employees.

The Supreme Court reversed in a 6-3 decision, holding that “§ 1514A extends whistleblower protection to employees of privately held contractors who perform work for public companies.”   The Court found that “clear from the legislative record is Congress’ understanding that outside professionals bear significant responsibility for reporting fraud by the public companies with whom they contract, and that fear of retaliation was the primary deterrent to such reporting by the employees of Enron’s contractors.”

Justice Ginsburg delivered the opinion of the Court, in which Chief Justice Roberts and Justices Breyer and Kagan joined. Justice Scalia, joined by Justice Thomas, filed an opinion concurring in principal part and concurring in the judgment. And Justice Sotomayor filed a dissenting opinion, in which Justices Kennedy and Alito joined.

Following the Lawson decision, privately held companies should carefully review their policies to ensure that they protect employees from retaliation for the reporting of fraud or other dishonest behavior by their customers and clients, especially customers and clients that are public companies.

Good Reprint Practices Revamped

By Casper E. Uldriks

The Food and Drug Administration (FDA) issued a revised draft guidance document in February 2014 entitled, “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.”  The guidance updates the draft guidance issued in January 2009 entitled, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.”   The Food and Drug Modernization Act (FDAMA)  (21 U.S.C. § 360aaa) amended the Food, Drug, and Cosmetic Act (FD&C Act) to include the regulatory conditions under which a reprinted published medical or scientific article may be distributed by a manufacturer to healthcare professionals and related healthcare businesses.The regulatory issue continues even though the FDAMA amendment is no longer in effect.

The purpose of establishing Good Reprint Practices was to describe the conditions under which medical or scientific literature concerning off-label use of a drug, biologic or medical device could be distributed without prompting FDA to say the information misbranded a product that has an approved use.  The Good Reprint Practices created a “safe harbor” for off-label use information that would otherwise be prohibited based on a misbranding charge.  Manufacturers must heed the guideposts of “should” and “should not” when navigating within the safe harbor.

FDA uses several factors to determine whether or not a medical or scientific journal article stays within the safe harbor. By following FDA’s guidance on what a manufacturer should and should not do, FDA will not use the dissemination of the reprinted medical or scientific article as evidence of a manufacturer’s intent to promote and market an off-label use.

A manufacturer should consider the following before it disseminates a reprint of a medical or scientific article about an unapproved use:

1. The article should be published by an entity with an independent editorial board with relevant expertise and objectivity.

2. The editors, authors and contributors associated with the article are subject to full disclosure of a conflict of interest based on a publicly stated policy.

3.  The article should be peer-reviewed under the publishing organization’s established procedures.

4.  The article should appear in its unabridged form.

5.  The article should describe the information in the context of being derived from adequate and well-controlled clinical investigations.

6.  The article should be disseminated with the product’s approved labeling.

7.  A comprehensive bibliography should be disseminated with information from other publications that is contrary to the results.

8.  The article should not be used in conjunction with or associated with any other promotional literature or activity.

The following are steps that a manufacturer should not take when disseminating a medical or scientific article about an unapproved use:

1. It should not be funded to any degree by one or more of the manufacturers’ products that are related to the article’s subject.

2.  It should not be altered to highlight, emphasize or promote an unapproved use.

3.  It should be disseminated primarily by the manufacturer as opposed to through an independent distribution channel.

4.  It should not be written, edited, excerpted, significantly influenced or published for, or at the request of, the manufacturer.

5. The article should not be attached to other specific product information.

In addition to the above steps that a manufacturer should and should not take, FDA also looks at the context in which the information is provided.  For example, the article should not be placed in proximity of the manufacturer’s products and promotional literature at a trade show for products it markets legally.  The reprint should be marked with a disclosure about the manufacturer’s interest in the product and state that the off-label use has not been approved by the FDA.   Financial conflicts of interest on the part of the manufacturer, author and any entity affiliated with the author are a major concern.  Conflicts of interest should be fully disclosed.  Likewise, the source of funding for the medical or scientific study should be identified.

Apart from providing a safe harbor for medical and scientific information about off-label use, there are practical professional considerations that involve the off-label use of the product for treating patients.  The manufacturer should provide what information it has regarding the risks associated with the unapproved use and include precautionary information and warnings that are already associated with the product.

The boundaries for FDA’s safe harbor are not new.  FDA started to develop the concepts for Good Reprint Practices in 1997 in response to FDAMA.  The updated draft guidance serves to illustrate how manufacturers should avoid creating false or misleading or otherwise violative information, even under the guise of professional education.  The safe harbor raises questions about the information itself, how and where it is disseminated and any conflicts of interest that may be associated with the reprinted article.

“Evaporated Cane Juice” — Comment Period Reopened

By Michael J. O’Flaherty and Stewart D. Fried

“Evaporated cane juice” is an ingredient name for a sweetener often seen in food labeling.

In October 2009, FDA issued a draft guidance document, essentially advising industry of FDA’s view that the common or usual (C/U) name for the solid or dried form of sugar cane syrup is “dried cane syrup,” and that a sweetener derived from sugar cane syrup should not be declared on food labels as “evaporated cane juice” because that name falsely suggests the sweetener derives from a juice.  See generallyDRAFT Guidance for Industry: Ingredients Declared as Evaporated Cane Juice (Oct. 2009).  FDA premised its guidance on a regulatory definition of “juice”:

Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.

21 C.F.R. § 120.1(a).  The original comment period on the guidance document closed in December 2009.

FDA’s regulations provide general requirements for C/U names to be used in the labeling of foods.  The C/U name must describe the basic nature of the food or its characterizing properties or ingredients.  Moreover, the C/U name must be uniform among all identical or similar products and may not be confusingly similar to the name of any other food that is not encompassed within the same name.  21 C.F.R. §102.5(a).

A substantial number of class action lawsuits have been filed, largely in California, against food manufacturers under state law, consumer protection theories, contending that the manufacturer misled consumers by using “evaporated cane juice” on the label.  Food manufacturers have had varying success in obtaining dismissal of such claims.  Although none of the cases has gone to trial yet, several settlement classes have been approved.  E.g., Singer v. WWF Operating Co. d/b/a Whitewave Foods, Case No. 1:13-cv-21232 (S.D. Fla.).

FDA has reopened the comment period on its guidance document.  79 Fed. Reg. 12,507 (Mar.5, 2014).  The agency invites comments, in particular, on the following matters:

  • What is the basic nature and characterizing properties of the ingredient sometimes declared as “evaporated cane juice”?  How is this ingredient produced?  How is its method of manufacture different from that of other sweeteners made from sugar cane (e.g., cane sugar, cane syrup, etc.)?  How does it compare with such other sweeteners?  Is there a uniform industry standard for this ingredient as traded in the marketplace?
  • Does the name “evaporated cane juice” adequately convey the basic nature of the food and its characterizing properties or ingredients, consistent with the principles in § 102.5(a)?  How does the name “evaporated cane juice” square with the principle that the name of a food may not be confusingly similar to the name of any other food that is not encompassed within the same name, given the significant differences in source and composition between this ingredient and beverages that are regulated as “juice” (e.g., orange juice and tomato juice)?
  • How is “evaporated cane juice” similar to, or different from, other sugars and syrups derived from sugar cane (e.g., raw sugar, cane sugar, cane syrup, demerara sugar, muscovado sugar, turbinado sugar, etc.) in terms of basic nature and characterizing properties or ingredients?  Considering that the ingredient is used as a sweetener derived from sugar cane, what would be the rationale for establishing a C/U name that identifies this ingredient as a “juice,” rather than as a “sugar” or “syrup,” and how would such an approach square with the principle that C/U names should be uniform and consistent among similar foods?
  • Applying the principles for C/U names in § 102.5, in what way does “dried cane syrup” fail to identify or describe this substance’s basic nature or characterizing properties or ingredients?

Data and other information submitted in support of comments are (of course) helpful.  Comments should be submitted by May 5, 2014.