• As our readership is well aware, FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact on the food industry of having to respond separately to each change.  That being said, FDA also sets specific compliance dates outside the uniform compliance date as needed.  For example, the compliance date for the Revision of the Nutrition Facts and Supplements Facts Labels, issued on May 27, 2016, is July 26, 2018, which effectively provides industry with more time than would have otherwise been permitted under a uniform compliance date.
  • Today, FDA announced that January 1, 2020 will be the uniform compliance date for food labeling regulations that are issued in calendar years 2017 and 2018.  The Agency notes that this action does not change existing requirements for compliance dates contained in final rules published before January 1, 2017.
  • All food products subject to the January 1, 2020 compliance date must comply with the appropriate regulations when initially introduced into interstate commerce on or after January 1, 2020.

The Daily Intake will return on Monday, November 28.  We extend our best wishes to those of you celebrating the upcoming Thanksgiving holiday.

  • As previously covered on this blog, FDA published a final rule on revisions to nutrition labeling requirements on May 27, 2016.  The final rule requires that only certain naturally occurring dietary fibers – such as those found in fruits, vegetables and whole grains, and added isolated or synthetic fibers that FDA has determined have a physiological effect that is beneficial to human health – may be declared on the label under “Dietary Fiber.”  Prior to the issuance of this rule, fibers in foods could be labeled as dietary fiber without necessarily providing physiological effects that are beneficial to human health.  Naturally occurring fibers contained in foods have already been determined to have physiological benefits.  In addition to fiber that is naturally occurring in foods, the rule identified 7 fibers that, when added to foods, could be declared as “dietary fiber.”
  • Today, FDA issued a request for scientific data, information and comments to help it determine whether certain fibers should be added to the definition of “dietary fiber” published as part of the Nutrition Facts label final rule.  The Agency has also issued draft guidance.  This guidance document explains the Agency’s current thinking on information needed when submitting a citizen petition and the scientific review approach the Agency plans to use for evaluating scientific evidence to determine whether an isolated or synthetic non-digestible carbohydrate that is added to food has a physiological effect that is beneficial to human health.
  • FDA will formally publish and begin accepting comments on its request for scientific data, information and comments and the accompanying draft guidance tomorrow, November 23, 2016.  With respect to the draft guidance, the Agency notes that comments received within the first 60 days will be considered in the development of the final version of the guidance.  With respect to the Agency’s request for scientific data, information and comments, the Agency will be accepting comments within 45 days from its publication in the Federal Register.
  • As previously covered on this blog, back in February of this year, FDA announced that it would begin testing foods for glyphosate residues. By way of background, glyphosate is the active ingredient in popular garden weed killers and is reported to be the most-used agricultural chemical in the world.  Some environmental groups have called for a ban on the use of this substance in agriculture.  The International Agency for Research on Cancer (IARC) has labeled this herbicide as “probably carcinogenic to humans,” although the European Food Safety Authority (EFSA) disputes that conclusion.  In the United States, FDA has not routinely tested foods for the presence of glyphosate, in spite of a U.S. Government Accountability Office (GAO) recommendation that the Agency improve its testing methods and be more transparent with the public regarding the limitations of its analytical testing.
  • In media reports last week, FDA confirmed that the Agency’s testing for residues of glyphosate has been put on hold.  The FDA’s residue testing for glyphosate was part of a broader herbicides analysis program which commenced earlier this year.  According to media reports, FDA’s glyphosate testing has been somewhat challenging as there has been some disagreement regarding testing methodology.  When glyphosate testing resumes (at a date to be determined), testing is slated to be significantly expanded.  In the meantime, FDA has said that preliminary results showed no violations of legal tolerance levels allowed for glyphosate in the foods tested.
  • To be sure, glyphosate will continue to be the subject of controversy – both here at home and abroad.
  • As previously covered on this blog, on September 9, 2016, FDA announced the availability of its first draft guidance for industry entitled, “Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling,” which describes the type and quality of evidence that FDA recommends infant formula manufacturers and distributors have to substantiate structure/function claims in infant formula labels and labeling.  81 FR 62509 (September 9, 2016).
  • Today, FDA announced that it has reopened the comment period for this draft guidance in response to requests for additional time to submit comments.  The comment period will reopen on November 21, 2016 for 90 days.
  • Food and dietary supplement manufacturers have always had an obligation to adequately substantiate their products’ claims.  The development of a specific guidance document for infant formula structure/function claims, however, may result in additional scrutiny of such claims on infant formula labels.  Complying with FDA’s thinking on what constitutes adequate substantiation will help infant formula manufacturers defend against potential challenges (regulatory or otherwise) to their structure/function claims.  In this regard, industry should consider taking advantage of this additional time to provide their input on and help shape the final version of FDA’s guidance document for infant formula structure/function claims.

FDA shares interim data from ongoing sampling program.

  • The U.S. Food and Drug Administration (FDA) and industry are continually seeking innovative ways to curb foodborne illness outbreaks.  As covered previously on this blog, over the past several years, FDA has been executing a robust surveillance sampling program intended to promote food safety.  More specifically, in 2014, the FDA launched a proactive sampling program for a variety of commodities to learn more about the prevalence of disease-causing bacteria, including identifying patterns that may help predict and prevent future contamination events.  This ongoing, large-scale microbiological sampling program involves the collection of a statistically determined number of samples of certain commodities over 12 to 18 months and testing them for certain types of bacteria that can cause foodborne illnesses.  The FDA began sampling and testing cucumbers and hot peppers as these products have previously been associated with large-scale outbreaks of foodborne illness.
  • Today, the FDA shared interim data from its ongoing sampling program.  As of October 1, 2016, the Agency indicates that it has tested 1,050 cucumber samples and 1,130 hot pepper samples. Of the cucumber samples, 15 tested positive for Salmonella while the rest tested negative for all of the targeted pathogens. Of the hot pepper samples, 35 tested positive for Salmonella, and one tested positive for a strain of Shiga-toxin producing E. coli that was determined to be incapable of causing severe illness, while the rest tested negative for all of the targeted pathogens. The testing is still ongoing and no conclusions can be drawn at this time.
  • FDA indicates that as more data becomes available, the Agency will continue to share test results from sampling assignments, including total number of samples collected and tested, sample type, and pathogen detected for positive samples.

Health Canada is proposing to eliminate partially hydrogenated oils (PHOs) from foods sold in Canada.

  • The use of partially hydrogenated oils (PHOs) in foods has come under scrutiny in the past several years.  For example, as previously covered on this blog, the U.S. Food and Drug Administration announced on June 16, 2015 that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) under any conditions of use in food.  Following FDA’s action, the Grocery Manufacturers Association (GMA) submitted a food additive petition to FDA seeking approval of specific low-level uses of PHOs, up to a maximum consumption level of 1.5% of a person’s daily energy.  This petition is still pending.  In the meantime, other jurisdictions, like neighboring Canada, have sought to address the use of PHOs food.
  • On October 24, 2016, Canada’s Minister of Health launched the Healthy Eating Strategy for Canada.  One initiative highlighted in the Healthy Eating Strategy involves the elimination of industrially produced trans fats in foods available in the Canadian marketplace.  To support this initiative, Health Canada has launched a 60-day consultation on its proposal to eliminate the use of PHOs (the main source of industrially produced trans fats) in foods sold in Canada.
  • Health Canada will be accepting comments on its proposal to prohibit the use of PHOs in foods sold in Canada through January 13, 2017.

Consumers and lawmakers in five cities recently voted to join Berkeley, CA and Philadelphia in taxing soft drinks (see our June 17, 2016, blog entry for more information on Philadelphia’s tax).

  • On Nov. 7, 2016, voters in San Francisco, Oakland and Albany, CA; and in Boulder, CO passed measures to tax nonalcoholic beverages with caloric sweeteners. In Boulder, distributers will be taxed 2-cents-per-ounce, while California cities will impose a one-cent-per-ounce tax. Marketwatch reported that a one-cent-per-ounce tax could translate to increased prices to the consumer of 20% or more if fully passed along. The tax votes passed with 62% of the vote in San Francisco, 61% in Oakland, 71% in Albany and 54% in Boulder, CO.
  • On Nov. 10, 2016, the Cook County Board of Commissioners voted to impose a one-cent-per-ounce tax on sodas. Cook County is home to Chicago and its suburbs and is the largest jurisdiction to impose a soft drink tax. Unlike the other soda taxes, Cook County’s will include beverages containing artificial sweeteners. The tax is scheduled to go into effect on July 1, 2017.
  • While proponents of the taxes cite efforts to reduce obesity and other health benefits associated with soft drink taxes (see our October 12, 2016, blog entry, WHO Report Supports Effectiveness of Sugary Food and Drink Taxes), jurisdictions are also looking at soft drink taxes as revenue generators. For example, Cook County estimates that its new soda tax will raise $221 million annually, enough to bridge it current budget gap. In a statement on the new tax, Cook County Board President Toni Preckwinkle said that the tax would put the county “on a stable financial footing for the next three fiscal years during which we will not have to approve any additional tax increases and allow us to double our investment in community-based anti-violence initiatives.” It is likely that other U.S. jurisdictions will now pursue similar legislation.

USDA’s Agricultural Marketing Service (AMS) has released a proposed rule which seeks to improve the Agency’s oversight of how companies use the USDA name and Process Verified Shield.

  • USDA’s Agricultural Marketing Service (AMS) administers the USDA Process Verified Program.  Companies with an approved Process Verified Program may develop promotional materials associated with their process verified points, use the USDA Process Verified Program shield in accordance with Program requirements and market themselves as “USDA Process Verified”.  By way of an example, the Process Verified Program allows companies to develop marketing claims such as “cage-free” or “tenderness guaranteed”.   The USDA Process Verified Program does not obviate the need to meet regulatory requirements set by USDA’s Food Safety and Inspection Service (FSIS).
  • On November 7, 2016, USDA’s AMS released a proposed rule which seeks to improve AMS’ oversight of how companies use the USDA name and Process Verified Shield.  In particular, the Agency is proposing to amend its regulations to better reflect the current needs of AMS’ Quality Systems Verification Program (QSVP) activities and to implement changes created by the 2013 merger of the AMS Livestock and Seed Program and the AMS Poultry Program.  Aside from calling for various technical and administrative amendments, key aspects of the proposed changes include:
    • amending the Livestock, Meat, and Other Agricultural Commodities QSVP to expand the commodities under the QSVP to include those authorized under the Agricultural Marketing Act of 1946 and
    • more clearly identifying and defining the types of programs and services offered under AMS’ QSVP.
  • The Agency will be accepting comments on the proposed rule through January 6, 2017.

FSIS has issued a notice indicating that meat and poultry manufacturers may voluntarily use FDA guidelines on nutrition labeling pending the issuance of updated FSIS Nutrition Facts labeling requirements.

  • As our readership is well aware, FDA finalized its Nutrition Facts labeling requirements on May 20, 2016.  See previous blog coverage here.  Recently, USDA announced that it would update its Nutrition Facts labeling requirements for meat and poultry food products.
  • Today, USDA’s Food Safety and Inspection Service (FSIS) issued a notice announcing that meat and poultry manufacturers may voluntarily use FDA guidelines on nutrition labeling while FSIS is in the process of drafting its Nutrition Facts labeling rules for meat and poultry products.  Once FSIS publishes a final rule to update the Nutrition Facts label format for meat and poultry products, companies would have to comply with that final rule.
  • It remains to be seen whether, and to what extent, USDA’s updated Nutrition Facts labeling rule will track FDA’s requirements.

The FDA has released final industry guidance to support compliance with its Voluntary Qualified Importer Program.

  • The Food Safety Modernization Act (FSMA) (Pub. L. 111-353) required FDA to establish a voluntary, fee-based program called the Voluntary Qualified Importer Program.  This program aims to facilitate the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes: (1) importation of food from facilities that have been certified in accordance with FDA’s program for Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (see previous blog coverage on FDA’s final rule concerning the Accreditation of Third-Party Certification Bodies here) and (2) other measures that support a high level of confidence in the safety and security of the food they import.  The Agency thinking here is that expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by permitting FDA to focus its resources on food entries that pose a higher risk to public health.
  • Today, FDA released final guidance for industry to support compliance with its Voluntary Qualified Importer Program. The final guidance, set forth in question-and-answer format, explains how this program will work. In brief, this guidance document addresses:
    • The benefits VQIP importers can expect to receive;
    • The eligibility criteria for VQIP participation;
    • Instructions for completing a VQIP application;
    • Conditions that may result in revocation of participation in VQIP; and
    • Criteria for VQIP reinstatement following revocation.
  • An FDA Fact Sheet on the Final Guidance is also available here.  The release of this final guidance represents the latest in a slew of FSMA related guidance documents issued by FDA over the past several weeks.