California adopts Prop 65 lead agency website regulation.

  • The California Safe Drinking Water and Toxic Enforcement Act of 1986 – also known as “Proposition 65” or “Prop 65” – requires the Governor of California to publish a list of chemicals known to the State to cause cancer or reproductive toxicity.  The list is updated by the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency at least once per year.  Under Prop 65, entities may not knowingly discharge or release listed chemicals into drinking water, and entities also must provide a “clear and reasonable warning” before exposing individuals to significant amounts of listed chemicals.  Many food and beverage companies are familiar with the Prop 65 warning requirement and the potential for lawsuits where exposures are detected in the absence of appropriate warning statements.
  • OEHHA is in the process of revisiting its Prop 65 regulations, which ultimately may include changes to the warning requirement itself.  Earlier this month, California adopted a new regulation to establish a framework for a new OEHHA website that will provide supplemental information to the public about warnings they receive for exposures to Prop 65 listed chemicals.  The new regulation will be effective on April 1, 2016.  Under the new regulation, OEHHA may request that a manufacturer, producer, distributor, or importer of a product bearing a Prop 65 warning provide the Agency with supplemental  information about the listed chemical(s), including the name, location, and concentration of the chemical(s), as well as anticipated routes and levels of exposure.  Although the data submission requirements are an additional burden for the industry, it is not clear how often OEHHA will request supplemental information from companies.  The new regulation does not require companies to perform additional testing to generate data.  Rather, a party must provide information that is already reasonably available.  Significantly, requests may be answered through a trade association if OEHHA seeks information from two or more businesses regarding the same product or exposure.
  • Many industry trade associations and companies have opposed development of the new website, arguing that the Agency lacked the statutory authority to require companies to provide the additional information sought.  Although OEHHA added certain clarifying language and concessions during the development of the regulation — including certain protections for trade secrets and a process for correcting information that appears on the website — the full impact of implementation and the ultimate value of the new website to consumers remains to be seen.

CPSC likely to gain new authority over packaging of some nicotine-containing e-liquid products.

  • The Consumer Product Safety Commission (CPSC) currently implements the Poison Packaging Prevention Act of 1970 (PPPA), which requires certain household substances to have packaging that makes it significantly difficult for children under five years old to open within a reasonable amount of time.  The PPPA has been credited with significant reductions in children’s deaths related to the unintentional ingestion of pharmaceutical products.
  • This month, Congress passed the “Child Nicotine Poisoning Prevention Act,” which will extend child-resistant packaging requirements to certain packages of nicotine-containing “e-liquid.”  Specifically, the law applies to “liquid nicotine containers,” defined to include “package[s] from which nicotine in a solution or other form is accessible through normal and foreseeable use by a consumer and that is used to hold soluble nicotine in any concentration.”  Click here for additional details regarding the scope and applicability of the law.
  • Prior to passage of the federal law, several states had already passed legislation requiring child-resistant packaging for e-liquid products, and many responsible manufacturers had already been using such packaging in the marketplace.  A major trade association representing e-liquid manufacturers — the American E-Liquid Manufacturing Standards Association (AEMSA) — has required child-resistant packaging for its members since 2012.  Assuming that the President signs the current bill, it is anticipated that the new legal requirements will be met with support from the industry and from consumers alike.

Keller and Heckman LLP has an active tobacco & e-vapor regulatory practice; for more information about this practice area in general, click here.

WHO recommends regulatory measures to slow sugar’s contribution to global childhood obesity.

  • Since the late 1980s, the World Health Organization (WHO) has recommended reducing dietary intake of free sugars (i.e., those added to foods and drinks and those naturally present in honey, syrups, fruit juices and fruit juice concentrates).  The WHO’s advice is based on the connection between a high level of free sugar intake and poor dietary quality, obesity, and risk of noncommunicable diseases.
  • The WHO has just issued a report urging the food industry and global governments to take active steps to slow sugar’s contribution to childhood obesity.  Specifically, the report discusses the benefits of regulatory actions such as mandatory nutrient labeling, a sugar tax, restrictions on the marketing of sugary foods to children, and consumer education campaigns.
  • Although the WHO certainly is viewed as an authoritative public health body, decisions about appropriate regulatory responses to sugar consumption and childhood obesity ultimately remain in the hands of individual governments.  In the United States, the federal government is taking a more active role with respect to the marketing and labeling of added sugar, with FDA poised to include a mandatory declaration and a daily value (DV) for added sugar as part of its comprehensive nutrition labeling revisions.  For the first time ever, the recently-released Dietary Guidelines for Americans recommend capping added sugar intake at 10% of one’s daily caloric intake.  The full global impact and response to the WHO’s report remains to be seen, but we anticipate that added sugars will continue to occupy the public health spotlight for many years to come.

New Jersey amends law to facilitate distribution of dietary supplements by physicians.

  • In recent years, the dietary supplement industry has grappled with concerns about regulation and enforcement action at the state level.  In terms of state-specific regulation, New Jersey law prohibited physicians from distributing more than a 7-day supply of any drug and imposed pricing restrictions on drug sale.  The law did not distinguish between pharmaceuticals and dietary supplements, even though a 7-day supply restriction is a non-starter in the supplement area.
  • New Jersey has now amended its law to exempt from the restrictions any “licensed physician, podiatric physician, or chiropractic physician who dispenses food concentrates, food extracts, vitamins, minerals, herbs, enzymes, amino acids, tissue or cell salts, glandular extracts, neutraceuticals [sic], botanicals, homeopathic remedies, and other nutritional supplements.”  The law received early and continued support from a leading trade association, the Council for Responsible Nutrition (CRN).
  • The lifting of New Jersey’s prior restrictions is being welcomed as a positive development in the supplement industry and one that will allow doctors to integrate supplements into patient health care regimens.  Still, the industry must remain attuned to regulatory and enforcement activities at the state level.  Many will recall that the widely-publicized 2015 investigation of the dietary supplement industry — targeting major retailers for marketing allegedly misbranded products — was kickstarted by the New York Attorney General before expanding to other states.  The significance of state-level activity in the supplement area should not be discounted.

Roos Foods pleads guilty to FD&C Act violation in connection with 2014 Listeria outbreak.

  • Thanks to the FDA Food Safety Modernization Act (FSMA), FDA now has the authority to suspend a food facility’s registration where there is a “reasonable probability” (of which the facility is or should be aware) that exposure to food will cause serious adverse health consequences or death to humans or animals.  A suspension effectively shuts down a food facility.  In March 2014, FDA suspended the registration of Roos Foods when their cheeses were linked to Listeria monocytogenes and where insanitary conditions (e.g., leaking roof, standing water) existed in the facility.  The Department of Justice (DOJ) eventually brought criminal charges against the company in connection with its distribution of tainted cheeses in interstate commerce.
  • Roos Foods has now pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act by introducing adulterated food into interstate commerce.  Should the company wish to re-open in the future, it is subject to numerous stringent conditions under a consent decree, such as obtaining support from third-party experts and labs to develop a remedial food safety plan aimed at dealing with Listeria.  The facility also would need to allow FDA to make unannounced inspections at any time and must bear the costs of these inspections.
  • The disposition of the Roos Foods case shows the significant potential long-term impact that food safety issues can have on a company.  In particular, DOJ recently indicated that a key area of increased focus for the Department is food safety.  The guilty plea in this case is further evidence of FDA’s/DOJ’s power to target and prosecute facilities for food safety violations.

NOP issues final guidance on substances that may be used in post-harvest handling of organic products.

  • The U.S. Department of Agriculture (USDA) administers the National Organic Program (NOP), which includes standards for “organic” food in the United States.  The use of synthetic substances generally is prohibited in organic foods, with the exception of specific materials that have been evaluated and added to a national list of allowed and prohibited substances (“National List”).  The National List also specifies nonsynthetic substances that may not be used in organic production.  Although the National List identifies substances that may or may not be used in organic production, it does not address the use of substances in post-harvest handling of organic products.
  • NOP recently issued a final guidance document to address this issue.  Titled “Substances Used in Post-Harvest Handling of Organic Products (NOP 5023),” the guidance clarifies USDA’s organic regulations with respect to substances used in post-harvest handling activities, such as washing, cleaning, sorting, packing, cooling, and storing of raw agricultural products, and facility pest management.  According to the guidance, substances that may be used in post-harvest handling include:
    • substances allowed for use in handling in the National List (where there are no restrictions specified that would prevent such use);
    • nonsynthetic substances allowed for use in crop production (where there are no restrictions in the National List that would prevent such use); and
    • synthetic substances in the National List (where they are specifically annotated to permit post-harvest use).
  • The guidance document provides greater clarity for accredited certifying agents and organic operations and helps resolve the confusion that previously existed in this area.

CSPI releases report criticizing use of artificial colors in food.

  • In recent years, both FDA and the food industry have faced criticism from consumer safety groups and the media related to the use of artificial colors in food, particularly where some ingredients are not approved or have been discontinued in other countries due to alleged safety concerns.
  • In January 2016, the Center for Science in the Public Interest (CSPI) released a report criticizing the continued use of artificial colors in the United States, alleging that the use of such dyes may trigger behavioral problems in children, and urging FDA to take action to ban or curtail the use of such dyes.
  • Although CSPI’s report cites to a “growing consensus” that food dyes are linked to behavioral problems, FDA consistently has maintained that there is insufficient evidence of a causal effect.  The Agency continues to stand by the safety of color additives, and it is not clear that the latest CSPI report will change FDA’s position on this issue.

USDA loosens livestock export rules.

  • The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) has regulatory authority over both the import and export of livestock products.  In the import context, APHIS works to ensure that products entering the U.S. meet the Agency’s entry requirements to exclude pests and diseases.  In the export context, APHIS works to keep export markets open for American products by seeking to eliminate unjustified sanitary or phytosanitary (SPS) barriers imposed by trading partners.
  • On January 20, 2016, APHIS issued a final rule to loosen restrictions on livestock exports from the U.S.  The new rule removes most previously-applicable requirements related to export health certifications, tests, and treatments and instead directs exporters of horses, cattle (including American bison), captive cervids, sheep, swine, and goats to comply with the importing country’s regulations.  APHIS is retaining only those export health certification, testing, and treatment requirements that the Agency considers necessary to have assurances regarding the health and welfare of livestock exported from the U.S.  The regulations take effect on February 19, 2016.
  •  The goal of the new rule is to provide APHIS and exporters with more flexibility in arranging for the export of livestock from the U.S. while continuing to ensure the health and welfare of animals.

Leading dietary supplement trade association to require all members to submit product labels to centralized database.

  • As previously covered on this blog, a leading dietary supplement trade association — the Council for Responsible Nutrition (CRN) — has been pursuing the goal of creating a Voluntary Product Registry for Dietary Supplements.  According to CRN, the goal of the registry is to increase transparency and give regulators greater access to information about the composition of supplement products currently on the market.
  • As a first step in creating a centralized label database, CRN will be requiring all member companies to submit their supplement product labels to the Dietary Supplement Label Database (DSLD) currently maintained by the National Institutes of Health (NIH) Office of Dietary Supplements (ODS).  The requirement will apply to member companies listed as the responsible party on the product label and will take effect in 2017.  CRN has some concerns about the robustness of the current NIH database and has submitted comments to ODS requesting improvements such as increased processing capabilities, a more refined product numbering system, and a clear process to govern label updates and the removal of errors from the database.  CRN also proposes to provide non-public information (to which only FDA would have access) about the parties who manufacture and package products in the DSLD, which could be useful to the Agency where the party named on the label serves only as the distributor.
  • CRN is the first trade association to require its members to submit labels to a centralized repository, although others may follow suit.  For years, good actors in the dietary supplement industry have worked to counteract the negative publicity associated with the marketing of illegal or tainted products.  The full impact of this concrete step toward transparency — both in terms of public perception and regulatory scrutiny — remains to be seen.

GAO report critical of USDA’s response to disease outbreaks

  • USDA has the authority to implement response measures to animal disease outbreaks to limit economic, animal health, and food security consequences. On January 14, 2016, the Government Accountability Office (GAO), the independent investigative arm of Congress, publically released a report critical of the USDA’s response to outbreaks of emerging animal diseases.  GAO studied USDA’s response to two highly contagious diseases, referred to collectively as Swine Enteric Coronavirus Diseases (SECD), that caused the deaths of millions of pigs in the U.S. in 2013 and 2014.  GAO concluded that, although USDA took steps to improve its response following the 2013 outbreak, the Agency needs to implement additional measures to better prepare for emerging animal disease outbreaks.
  • When SECD were first identified in the U.S. in May 2013, USDA did not take regulatory action based, in part, on the fact that SECD is not known to pose a risk to any species other than swine, the disease is not lethal to all pigs, and a quarantine would have resulted in the euthanasia of large numbers of animals – because swine are often moved among different premises to accommodate their growth, many facilities are unable to humanely house pigs larger than they customarily handle.  GAO concluded that USDA’s failure to take swift regulatory action limited the Agency’s understanding of and ability to respond to the outbreak.
  • In 2014, USDA issued a federal order imposing reporting and planning requirements and provided financial assistance to states and producers.  The Agency also released draft guidance and a proposed list of animal diseases that must be reported by anyone with knowledge of the diseases.  While the GAO report praised these efforts, the report notes that USDA still needs to define and communicate key aspects of its approach for responding to emerging animal diseases, including when the agency will take a lead role, what the agency’s responsibilities will be, and examples of circumstances that may trigger actions such as euthanasia or quarantines.  USDA indicated that it intends to refine and expand the draft guidance to clarify these matters.  As is the case for food borne illness, USDA must engage in a difficult balancing act when determining how to respond to animal disease outbreaks – if the Agency implements restrictive measures to contain an outbreak before all facts are known, it may impose needless costs if the outbreak is later discovered to be low risk, but if the Agency waits to act until more is known, it may be giving a virulent, lethal disease time to spread.