A recent World Health Organization (WHO) report supports the notion that taxing sugary foods and drinks could lead to a decrease in the consumption of such products and reduce obesity, type 2 diabetes, and tooth decay.

  • A number of jurisdictions in the U.S. and abroad have implemented fiscal policy interventions – by way of taxes – as a means of ostensibly improving diets and preventing certain diseases.   According to WHO, several countries, including Mexico and Hungary, already tax sugary products, and the Philippines, South Africa and the U.K. are slated to implement similar measures in the near future.  In a recent example (and as previously covered on this blog), on June 16, 2016, the Philadelphia city council voted 13-4 to approve a 1.5 cent per ounce tax on sugar-sweetened beverages.  This “soda tax” has come under fire from industry and consumers alike, and is currently the subject of ongoing litigation seeking to upend the new law.
  • Yesterday, WHO released a report finding that “the taxation of certain sugary foods and drinks, particularly those high in saturated fats, trans fat, free sugars or salt, ‘appears promising,’ with existing evidence ‘clearly showing’ that increasing the prices of such products reduces their consumption.”
  • It remains to be seen whether and to what extent additional jurisdictions, both at home and abroad, will seek to pursue such legislation.

The U.S. Food and Drug Administration (FDA) has received a number of questions on the timing of compliance dates for its nutrition initiatives. In response, the Agency published a reminder of those compliance dates on October 7, 2016. See: Questions and Answers for Food Manufacturers on Compliance Dates for Nutrition Initiatives.

  • Several of FDA’s key nutrition initiatives have compliance dates during the summer of 2018.
    • After June 18, 2016, food products may not contain partially hydrogenated oils (PHOs) for uses that have not been cleared by FDA. This is a result of a final determination by FDA that there is no longer a consensus among qualified experts that PHOs are generally recognized as safe (GRAS). For background information, see our blog entry, PHO Protections.
    • On July 26, 2018, manufacturers with $10 million or more in annual food sales will need to comply with new Nutrition Facts label requirements. Final rules to implement changes to nutrition labeling requirement were issued by FDA on May 20, 2016. For background information, see our blog entry, FDA Final Rule Alert: Revised Nutrition Facts and RACCs.
    • On July 26, 2018, operators of vending machines with glass fronts will have to comply with all requirements of the vending machine labeling rule. The original compliance date was December 1, 2016; however, FDA delayed the compliance date to be consistent with the Nutrition Facts label requirements
  • The targets for sodium reduction that FDA is developing are voluntary, therefore, they do not have a compliance date. However, FDA published draft voluntary short-term (2 years) and long-term targets (10 years) for reducing sodium in commercially processed and prepared food. For background information, see our blog entry, FDA Draft Guidance: Scaling Back Sodium.

The European Commission plans to roll out proposed nonbinding legislation on acrylamide levels in food for EU member states’ consideration.

  • Acrylamide is a chemical that forms during high-temperature cooking of certain foods, e.g., in the preparation of French fries, toasting of bread, or roasting of coffee.  The European Food Safety Authority (EFSA) officially recognized acrylamide as a potential carcinogen in 2005.  Since then, industry efforts have been ongoing to reduce acrylamide levels in the food supply.  Most recently, on June 4, 2015, EFSA issued an opinion warning of increased cancer risk from acrylamide for all age groups.
  • The European Commission intends to put forth a draft regulation to EU member states in the Standing Committee on Plants, Animals, Food and Feed (PAFF) this November.  Under the draft regulation, companies would be asked to respect voluntarily “indicative values” for acrylamide in food.  Critics note that in many cases the indicative values are higher than the levels of acrylamide already discovered in food during tests conducted by national authorities and industry.
  • Given the increased spotlight on acrylamide in both the EU and the U.S., we can be certain that regulatory authorities in both jurisdictions will continue to monitor acrylamide levels in food to determine whether further regulation is needed.

FDA has issued an updated Manufactured Food Regulatory Program Standards (MFRPS) for state regulatory programs that oversee food facilities.

  • Since May 2007, FDA has issued regulatory program standards, known as the Manufactured Food Regulatory Program Standards (MFRPS), for state regulatory programs that oversee food facilities that manufacture, process, pack, or hold foods. FDA touts the MFRPS as an important component in establishing the national Integrated Food Safety System. An MFRPS fact sheet is available here.
  • On October 5, 2016, the FDA issued a revised MFRPS. The 2016 updates include newly defined terms, new sections and appendices, as well as updates to the current standards. A summary of the changes is available here.
  • Industry stakeholders should review the updated MFRPS to understand how federal and state authorities are directing their regulatory activities toward reducing foodborne illness hazards in plants that manufacture, process, pack or hold foods.

In a recent address to the UN General Assembly, the WHO Chief urged consumers to choose “antibiotic free” meats.

  • As previously covered on this blog here and here, for years, FDA, USDA, and various industry stakeholders have sought to tackle public health concerns associated with the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In the U.S., FDA is working with industry to gradually phase out the use of medically important antimicrobials in food animals for production purposes.
  • In a recent address to the UN General Assembly late last month, Dr. Margaret Chan, Director-General of the World Health Organization called on consumers to choose “antibiotic free” meat, noting that doing so would help stem the “slow motion tsunami” of antimicrobial resistance.
  • To be sure, meat industry stakeholders certainly recognize the potential human health risks posed by the abuse of sub-therapeutic antibiotics in food-producing animals and, to that end, have been working with industry to promote the judicious use of antibiotics in food-producing animals in the U.S.  That being said, meat industry groups are certain to challenge the WHO Chief’s blanket recommendation on grounds that the judicious use of antibiotics in food producing animals is safe.  It remains to be seen whether and how the WHO Chief’s aggressive position will affect the statements and recommendations of medical and public health groups going forward.

The food and beverage industry generally supports extending the use of point-of-sale (POS) signage to indicate exposures from bisphenol A (BPA) present in cans, lids, and caps of packaged food and beverages at retail stores; however, the industry strongly opposes the requirement that companies submit information on whether BPA was intentionally used in the manufacture of the can lining or jar or bottle seal so that this information may be posted on  California’s Office of Environmental Health Hazard Assessment (OEHHA) website.

  • BPA was added to the Prop 65 list as a reproductive toxicant in May 2015, and on April 18, 2016, OEHHA implemented an emergency rulemaking that allowed the use of POS signage to indicate exposures from BPA present in cans, lids, and caps of packaged food and beverages at retails stores until October 17, 2016. As reported on this blog, OEHHA issued a proposed rule on July 22, 2016, that would permit the POS signage for BPA until December 30, 2017. However, the proposal would require manufacturers, producers, packagers, importers, or distributors of foods where BPA is intentionally added to their packaging to send OEHHA specific information about the products to post on the “lead agency website” (in addition to sending similar information to retailers).
  • Comments on the proposal submitted jointly by the American Beverage Association, the Beer Institute, the Distilled Spirits Council, and the Wine Institute, supported adopting the current safe harbor warning for BPA in food as a non-emergency safe harbor warning until such time as OEHHA adopts a Maximum Allowable Dose Level (MADL) for BPA by the oral route of exposure. Conversely, the beverage associations opposed conditioning the availability of the BPA warning safe harbor upon a company’s submission of information concerning whether BPA “was intentionally used in the manufacture of the can lining or jar or bottle seals,” stating that approach would be misleading to consumers since, “[t]he presence of BPA in a food depends on much more than whether BPA has been intentionally used in the manufacture of the lining or seal.”
  • The Grocery Manufacturers Association (GMA) also submitted comments supporting the proposed extension of the signage program, while opposing the requirement that each manufacturer of food or beverage products provide information to OEHHA concerning those “products for which a warning is being provided” and” in which BPA was intentionally used in the manufacture of the can lining or jar or bottle seals.” Explaining, GMA stated, “…there is no rational relationship between the statute’s requirement that manufacturers warn consumers about exposures to listed chemicals above threshold levels and OEHHA’s requirement that manufacturers provide it with a list of food and beverage products in whose packaging BPA is used.” GMA also urged OEHHA to “develop an appropriate MADL for the ingestion route of exposure that is based on a review of the studies of sufficient quality,” adding “[w]ithout a published MADL for ingestion exposures to BPA, manufacturers and retailers using BPA will face unnecessary litigation risk if they do not either provide warnings or take the risks and incur the expense entailed in reformulation of their products.”
  • While the POS signage would provide a safe harbor warning for BPA in food and beverage products for 18 months, companies still must consider the risk of enforcement action if they do not provide some type of warning or eliminate BPA from food packaging, in the absence of a MADL for oral exposure.

FSIS is seeking comments on an updated compliance guideline regarding the documentation needed to support animal raising claims on meat and poultry product labels.

  • USDA’s Food Safety and Inspection Service (FSIS) administers the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA).  The FMIA and PPIA authorize FSIS to approve labels for meat and poultry products, including animal raising claims placed on such labels, before they are marketed in interstate commerce.  Examples of animal raising claims include but are not limited to:  “Raised Without Antibiotics,” “Organic,” “Grass- Fed,” “Free-Range” and “Raised Without the Use of Hormones.”  Current FSIS policy governing the use of such claims is set forth in a compliance guideline issued in 2002; an outline of the Agency’s current process for reviewing animal production claims – which describes the documentation that animal processors and plant operators must provide to the Agency to substantiate a given animal raising claim – is available here.
  • On September 30, 2016, FSIS announced the availability of an updated compliance guideline regarding the documentation needed to support animal raising claims on product labels that processors must submit to the Agency for approval of their use on product labels.  The updated guideline includes explanations of animal-raising claims that FSIS may approve, as well as the types of documentation the Agency requires to approve such claims.
  • For most animal-raising claims, the documentation typically needed to support these claims includes:
  1. A detailed written description explaining the controls used for ensuring that the raising claim is valid from birth to harvest or the period of raising being referenced by the claim;
  2. A signed and dated document describing how the animals are raised (e.g., vegetarian-fed, raised without antibiotics, grass- fed), to support that the specific claim made is truthful and not misleading;
  3. A written description of the product-tracing and segregation mechanism from time of slaughter or further processing through packaging and wholesale or retail distribution;
  4. A written description for the identification, control, and segregation of non-conforming animals or products; and
  5. If a third party certifies a claim, a current copy of the certificate.
  • The Agency will be accepting comments for 60 days following the imminent publication of the updated compliance guideline in the Federal Register.  In the meantime, the Agency encourages stakeholders who wish to submit requests for approvals of animal-raising claims on product labels to begin using the updated guideline.

Amendments to California’s Proposition 65 settlement terms, penalty amounts, and attorney’s fees in civil actions filed by private persons become effective October 1, 2016.

  • By way of background, Proposition 65—also known as the Safe Drinking Water and Toxic Enforcement Act of 1986—prohibits knowingly exposing any individual to a listed chemical without first providing a “clear and reasonable warning” to such individual. Private citizens may initiate Proposition 65 enforcement actions and, when they do so, they are entitled to 25% of any penalties assessed by the courts and attorney’s fees. An additional form of payment, called “payments in lieu of civil penalties” (PILPs), also is permitted under the Attorney General’s Proposition 65 enforcement regulations.  PILPs are funds paid to plaintiffs or plaintiffs groups to fund environmental activities, public education programs, and/or funds to the plaintiff for additional enforcement of Proposition 65 or other laws. Under the current payment scheme, the vast majority of payments under the statute go toward attorneys’ fees and PILPs.  These payments are not shared with OEHHA.
  • The California Attorney General’s Office proposed the amendment to Prop 65 in September 2015 in an effort to:
  1. Ensure that the Office of Environmental Health Hazard Assessment (OEHHA) receives the civil penalty funds specified in Proposition 65;
  2. Limit the ability of private plaintiffs to divert the statutorily mandated penalty to themselves or to third parties, in the form of Additional Settlement Payments (ASP);
  3. Increase the transparency of settlements in private party Proposition 65 cases, to ensure that any monies allocated to ASP are spent on matters with a sufficient nexus to the litigation and to the State of California; and
  4. Reduce the financial incentives for private plaintiffs to bring and settle Proposition 65 cases that do not confer substantial public benefit, without discouraging cases and settlements that do confer such benefit. (See: Final Statement of Reasons.)
  • The new regulations (Title 11, Division 4, California Code of Regulations) limit the circumstances under which civil penalties can be diverted to plaintiffs and their attorneys by eliminating PILPs and establishing payments called Additional Settlement Payments (ASPs).  ASPs are defined as payments that are not civil penalties, attorneys’ fees, or costs.  The ASPs are meant to “offset” civil penalties and require plaintiffs to demonstrate to a judge that the offset is in the public interest. Furthermore, the amount of ASPs in a settlement should not exceed the State’s 75% share of any noncontingent civil penalty, and the recipient is required to describe with specificity the uses to which funds will be put.
  • Currently, defendants faced with a Proposition 65 suit may decide to settle and reformulate, even when a listed chemical is likely present in a product at a level below which a warning would be required. The new regulations specify that reformulation of a product to reduce or eliminate the exposure to a listed chemical, in lieu of the provisions of a warning, must confer a significant benefit on the public. More specifically, “Where a settlement sets forth a standard or formula for reformulation, supporting evidence should show that at least some of the products in controversy in the action either are, or at some time relevant to the litigation were, above the agreed-upon reformulation standard or formula, or else the mere agreement to a reformulation standard or formula may not establish the existence of a significant public benefit.”
  • In comments to the proposed regulation, the California Chamber of Commerce suggested adding the underlined phrase in section 3201(b)(2): “When a settlement sets forth a standard or formula for when a given product requires a warning, supporting evidence should show that at least some of the products in controversy in the action contained concentration levels of a listed chemical or chemicals that either are, or at some time relevant to the litigation were, above the agreed-upon standard or formula itself may not establish the existence of a significant public benefit.” The AG rejected that proposal, stating that the reformulation standard for settlements over food products or dietary supplements may be expressed as a daily exposure based on the expected daily intake, rather than a concentration.
  • Many of the comments received on the initial proposal supported the proposed amendment, but suggested that they did not go far enough to curb abuses. While the amendment is intended to provide OEHHA with more money, it could result in higher settlement costs for defendants, especially since attorney fees are not limited.
  • As reported on May 20, 2016 on this blog, the Food and Drug Administration (FDA) issued final rules to implement changes to nutrition labeling requirement in the U.S. In our summary of the final rule on the Nutrition Facts label requirements, we reported that FDA will require a declaration of the amount of added sugar and percentage daily value if a product contains 1 gram or more of added sugars in a serving, or if claims are made about sweeteners, sugars or sugar alcohol content.
  • Sean P. Duffy (R-WI) introduced the Fruit Labeling Accuracy Act of 2016 (H.R. 6142) on September 22, 2016, which would amend section 403(q) of the Federal Food, Drug, and Cosmetic Act to prohibit the FDA from requiring the percent of daily value of added sugars to be included in the labeling of certain nutrient-dense foods. More specifically, the bill would ban FDA from requiring the percent of daily value of added sugar to be included on the label of dried naturally tart fruits; or juice beverages that are made with at least 27% juice of a naturally tart fruit and contain no more than 28 grams of total sugars per serving or 111 calories per serving.
  • While this bill likely has little chance of passing, it signals an effort to amend the recently announced nutrition labeling requirements.

FDA has issued guidance updating the food product categories that companies can select when registering as a food facility with the agency.

  • Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA.  The registration requirement has been in effect since 2003.  However, the Food Safety Modernization Act (FSMA) added new provisions to the FD&C Act related to the registration of food facilities.  These new provisions were codified in a final rule published on July 14, 2016 (see previous blog coverage here).
  • On September 26, 2016, FDA issued guidance updating the food product categories that companies can select when registering with the agency.  Updates include:
    • Acidified foods and low acid canned foods are no longer listed as food product categories because they are now activity types
    • Additions to animal food categories of botanicals and herbs, direct fed microbials, animal protein products, forage products, human food by-products not otherwise listed and technical additives (The “animal protein products” category replaces the previous “animal derived products” category, and the “processed animal waste products” category replaces the “recycled animal waste products” category.)
    • Molluscan shellfish is now a food product category (previously, molluscan shellfish establishment was listed among the optional activity types)
  • The updated guidance explains that food companies will be required to select appropriate food product categories from the updated categories during the October – December 2016 registration renewal period. The guidance also explains that under certain FSMA amendments FDA is authorized to determine appropriate food product categories through guidance.  More specifically, under section 415(a)(2) of the FD&C Act (as amended by FSMA), a food facility must submit to FDA a registration containing information about the general food category (as identified in 21 CFR 170.3 or any other food categories as determined appropriate by FDA, including by guidance) of a food manufactured/processed, packed or held at such facility, if the Agency determines through guidance that such information is necessary.
  • Food industry stakeholders required to register with FDA should review and familiarize themselves with this newly-revised guidance and any potential implications for their businesses.