“100% Natural” claim challenged on products that contain GM ingredient. (subscription to Law360 required)

  • As the food industry is well aware, lawsuits challenging “natural” claims continue to proliferate nationwide, with particularly significant activity occurring in the Northern District of California (dubbed “The Food Court”).  Many challenges have focused on the presence or use of synthetic ingredients or processing aids in products positioned as “all-natural” or “100% natural.”
  • More recently, we have seen a trend toward “natural” challenges that focus on the presence of genetically modified (GM) constituents in food products.  In a lawsuit filed on June 8, 2015, a plaintiff has challenged Campbell Soup Co.’s “100% Natural” claim on Prego brand pasta sauces, citing the presence of GM canola oil in the products.  The challenge is premised on the allegation that reasonable consumers would not expect the presence of GM ingredients in a product positioned as wholly natural.  Considering that most (if not all) modern crops are “GM” based on the use of historical preferential breeding techniques, there is at least a reasonable argument that the use of GM technology does not render crops per se synthetic or artificial.
  • This is not the first GM-based “natural” challenge, nor is it likely to be the last.  The potential liability involved in such cases can be significant, as indicated by Kashi’s recently finalized $4 million settlement to end a class action lawsuit over the presence of GM components in its cereals and snack bars.  FDA has no official policy governing the use of “natural” claims, nor does the Agency appear likely to develop a definition in the foreseeable future.  In the meantime, the food industry’s actions in the “natural” claim space will likely continue to be shaped — and curtailed — by plaintiffs’ lawyers.

North Carolina’s recently enacted “Ag-Gag” law imposes civil consequences for interfering with private property.

  • “Ag-Gag” legislation generally seeks to prevent individuals or organizations from investigating and publicizing farming conditions and practices that occur on private property.  Several states have introduced and enacted Ag-Gag measures to date, but Utah’s and Idaho’s laws currently face constitutional challenges on 1st and 14th Amendment grounds.
  • In June 2015, North Carolina’s legislature enacted the “Property Protection Act” by overriding the Governor’s veto of H.B. 405.  Although the law is worded broadly enough to cover various industry sectors (e.g., nursing homes), the media has been focusing on its Ag-Gag implications.  Unlike other state Ag-Gag measures, the North Carolina law provides for civil remedies for interference with property, rather than criminal actions.  The law provides for recovery against a person who enters non-public areas of a premises to recover information subsequently used to breach that person’s “loyalty to the employer.”  Liability also extends to the use of surveillance (images, sound, or electronic) in non-public areas.  An employer may file a civil lawsuit and seek up to $5,000 per day for every day that violations continue.
  • The North Carolina provisions — and indeed, Ag-Gag laws in general — are likely to remain the subject of controversy in the weeks and months ahead.  Animal welfare activists view Ag-Gag laws as impeding the discovery and dissemination of information on improper or abusive farming practices.  The agriculture industry views Ag-Gag measures as necessary to protect farming operations from infiltration by undercover activists, corporate espionage, undue interference, and unwarranted negative publicity.  Particularly as Ag-Gag laws continue to be considered and challenged in other states, it remains to be seen whether North Carolina’s unique approach to providing civil remedies will be adopted elsewhere.

FDA Releases Draft Guidance on Voluntary Qualified Importer Program.

  • Under the FDA Food Safety Modernization Act (FSMA), FDA is required to establish a voluntary, fee-based program for the 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.
  • On June 5, 2015, FDA released Draft Guidance for industry on the Voluntary Qualified Importer Program (VQIP) for importers of human and animal food. The draft guidance outlines FDA’s planned implementation of the VQIP via a series of questions and answers addressing the benefits and eligibility criteria for participation, instructions on how to complete a VQIP application, conditions that may result in revocation of VQIP participation, and criteria for reinstatement following revocation. For the first year, FDA is estimating that a flat annual fee of approximately $16,400 will be paid by all VQIP participants.
  • Because VQIP participation hinges on certifications that must be issued by FDA-accredited third-party auditors/certification bodies, the VQIP program will not go into effect until after FDA’s third-party accreditation program is operational. FDA’s final rule to implement the third-party accreditation requirements is anticipated in November 2015.  At this point, importers should consult the Draft Guidance to develop a sense of how FDA envisions the role and operation of the VQIP.

Congress questions FDA policy regarding the publication of Untitled Letters.

  • FDA has the authority to issue two types of letters to regulated entities:  Warning Letters and Untitled Letters.  FDA issues Warning Letters to highlight alleged violations of the Federal Food, Drug, and Cosmetic Act that — if not appropriately resolved by the entity — may trigger enforcement action.  FDA issues Untitled Letters to highlight violative conduct that does not necessarily warrant enforcement action.  In practice, FDA posts Warning Letters on its website once redacted versions are available.  In contrast, FDA posts some — but not all — Untitled Letters on the web.
  • The U.S. House Committee on Energy and Commerce has sent a letter to FDA, indicating its intent to investigate the Agency’s policies regarding the “use and publication of untitled letters, including whether such policies and practices are consistently fair, effective, and efficient in gaining compliance.”  The letter cites the case of an unnamed company that was the recipient of an Untitled Letter that FDA posted in a manner that had a significant impact on the company’s stock price.  Congress appears to question both the timing and the nature of FDA’s release of information in that case.  Congress also seems concerned that FDA may be using Untitled Letters to advance new policies or interpretations without giving adequate notice to industry.  FDA has been asked to respond to Congress’ letter in writing by June 10, 2015.
  • According to FDA’s website, the Center for Food Safety and Nutrition (CFSAN) posts Untitled Letters related to violations from manufacturing controls or labeling that do not meet the threshold of significance for a Warning Letter, or that are issued to Internet websites (“Cyber Letters”).  Assuming that FDA is willing to engage with Congress on this issue, the Agency’s response may clarify the “publicity policy” with respect to Untitled Letters issued to food companies and could give the food industry more predictability with respect to the timing and nature of the release of information.

Registration is now open for Keller and Heckman’s Practical Food Law Seminar in Washington, D.C.!

Join us from September 29-October 1, 2015 in the firm’s D.C. office for a seminar that will provide members of the food industry with a comprehensive presentation of the applicable statutory and regulatory framework for foods (including dietary supplements).  The course will focus on food safety as well as labeling and advertising.

PFLS

FDA finalizes rule to require veterinary supervision of antimicrobial use in food-producing animals.

  • FDA and the animal feed industry have been working for years to address concerns about the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  As previously covered on this blog, FDA has requested voluntary industry efforts to reduce the use of antibiotics in food-producing animals and has proposed to expand the collection of data regarding the use of antibiotics in major food-producing species.  Congress also is considering a bill that would require FDA to withdraw the approval of particular antibiotics at high risk of abuse in food-producing animals.
  • On June 3, 2015, FDA published a final rule regarding Veterinary Feed Directive (VFD) drugs.  Under the new rule, the use of antimicrobials in food-producing animals must take place under veterinary supervision to ensure that such use occurs only when medically necessary to promote animal health.
  •  The rule represents only the latest in a series of steps being taken by FDA to promote the judicious use of medically important antimicrobial drugs in food-producing animals.  The animal drug and animal feed industries must remain attuned to developments in this space as numerous stakeholders continue to work together to reduce antibiotic use.

 

Blue Bell signs agreements with three states to address Listeria contamination.

  • As previously covered on this blog, Blue Bell Creameries has been dealing with the aftermath of a multi-state listeriosis outbreak linked to consumption of its ice cream products.  FDA has published inspectional observations for Blue Bell production facilities, indicating the company’s awareness of food safety violations in facilities dating back to 2007, as well as positive tests for Listeria monocytogenes in one plant as far back as 2013.
  • Blue Bell has signed voluntary agreements with health departments in Alabama, Oklahoma, and Texas specifying various steps that the company plans to take to address Listeria contamination prior to resuming the sale of products in these states.  The agreements include action items such as conducting root cause analyses to identify sources and potential sources of contamination; retaining the services of an independent microbiology consultant; notifying the health department of presumptive positive tests for Listeria and providing access to test results; targeting Listeria response as part of the company’s environmental monitoring program; and instituting a “test and hold” program prior to product distribution.
  • The agreements are illustrative of an extra-legal or quasi-enforcement strategy that state and local health authorities may deploy in the wake of a food safety crisis.  Particularly because of the high level of publicity associated with the Blue Bell situation, the agreements could have precedential value in the handling of future multi-state outbreaks.

Judge upholds convictions of defendants in Peanut Corporation of America case.

  • In 2008-2009, peanut products distributed by Peanut Corporation of America (PCA) were linked to a Salmonella outbreak that sickened over 700 people and caused 9 deaths across 46 states.  The government brought a criminal prosecution against PCA executives and employees, alleging that they had knowingly introduced tainted food into interstate commerce.  In September 2014, three key defendants were convicted of a host of criminal charges.
  • In May 2015, a judge upheld the three defendants’ convictions after considering a series of post-trial motions for acquittal and dismissal, as well as a request for a new trial.  The ruling means that the convictions of Stewart Parnell (former PCA owner), Michael Parnell (former peanut broker) and Mary Wilkerson (former quality control manager), will stand.  The Parnells’ convictions are sufficient to send the brothers to prison for the rest of their lives, while Wilkerson’s conviction carries a maximum sentence of 10 years in prison and a $250,000 fine.
  • The PCA-related Salmonella outbreak was one of the deadliest in modern history.  The severe criminal penalties that the defendants now face are indicative of the potential consequences that food companies — as well as their executives and employees — may face in the wake of food safety crises.

Researchers report effectiveness of FDA ban on ephedra.

  • In the 1990s and early 2000s, ephedra-based dietary supplements were widely marketed and consumed as stimulants and weight loss aids in the United States.  Ephedra consumption was linked to various serious adverse health effects, including heart attack, stroke, seizure, high blood pressure, and cardiac arrhythmia.  In certain cases, ephedra consumption was linked to sudden death.  FDA responded to the growing controversy over ephedra by investigating the safety of the substance, concluding that it posed an unreasonable risk to consumers, and ultimately issuing a final rule in 2004 to prohibit the sale of dietary supplements containing ephedra altogether.
  • Researchers have reviewed 13 years worth of data regarding ephedra-related deaths and poisonings, concluding that FDA’s ban on this substance produced a significant public health benefit.  According to the report, which was published in the New England Journal of Medicine, the “number of poisonings resulting in major effects or deaths has decreased by more than 98% since 2002.  The 2004 FDA ban has proved to be a very effective means of limiting the availability of ephedra and therefore its potential toxicity in the United States.”
  • The ephedra controversy resulted in FDA’s first official ban of a dietary supplement.  More recently, FDA took enforcement actions that resulted in an effective ban on the marketing of DMAA — a stimulant linked to high blood pressure, cardiovascular problems, and even heart attacks.  In the case of DMAA, however, FDA specifically noted that it had not undertaken the “lengthy scientific and legal steps” required by law for the Agency to formally ban a compound in a dietary supplement.  Rather, the Agency relied on Warning Letters and facility visits to stop firms from producing and marketing DMAA.  Even more recently, in the wake of increased media coverage citing concerns about beta-methylphenethylamine (BMPEA) in dietary supplements, FDA issued a series of Warning Letters to companies marketing this substance as a dietary ingredient in violation of the law.  It remains to be seen whether FDA’s more recent utilization of “effective bans” against dietary supplement products will have the same degree of public health efficacy as a formal prohibition.

Cannabidiol marketer challenges FDA’s view that such products may not be marketed as dietary supplements.

  • Under section 201(ff)(3)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the definition of a “dietary supplement” specifically excludes articles that are approved as new drugs, certified as antibiotics, or licensed as biologics, as well as articles that have been investigated for therapeutic uses for which “substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”  A product would not be excluded from the definition of a dietary supplement if it was marketed as a dietary supplement or as a food prior to formal regulatory approval or regulatory authorization to begin therapeutic investigations.  FDA has cited to the “drug exclusion” in section 201(ff)(3) on numerous occasions in Warning Letters to companies marketing approved drugs in dietary supplements.  Several Warning Letters addressed the marketing of dietary supplements containing sibutramine, a drug approved to treat weight loss (since withdrawn from the U.S. market).  In each case, FDA indicated that sibutramine was authorized for investigation as a new drug prior to its marketing as a dietary supplement or as a food.  Recently some have questioned FDA’s views regarding the permissible marketing of cannabidiol (CBD) products (containing substances derived from the marijuana plant) as dietary supplements.  CBD has been shown to have therapeutic promise and a drug company filed an investigational new drug application (IND) to investigate its use in the treatment of childhood epilepsy in 2013.
  • In a Q&A that FDA recently issued to address marijuana products, the Agency specifically states that “[based] on [the] available evidence” it has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act.  Recognizing this qualification, at least one company promoting CBD for dietary supplement use has openly challenged FDA’s conclusion and has asserted the existence of a CBD-based dietary supplement on the market since 2012, which would predate the filing of the IND.
  • In February 2015, FDA issued several Warning Letters to firms marketing CBD products as unapproved new drugs, based primarily on the claims made for such products.  In light of the Agency’s recently publicized view that CBD does not fit the dietary supplement definition, it remains to be seen whether future Warning Letters will target CBD-based dietary supplements on this basis.  Perhaps significantly, although FDA states that CBD products may not be sold as dietary supplements, the Q&A invites interested parties to “present the agency with any evidence that they think has bearing on this issue.”  The possibility exists that sufficiently robust evidence about the marketing of CBD products as dietary supplements prior to the investigation of therapeutic uses may change the Agency’s views on this point, although the practical likelihood of this happening is fairly low.