Vermont’s GM labeling law survives initial challenge.

  • For months, the food industry has anxiously awaited developments in the lawsuit brought by the Grocery Manufacturers Association (GMA) and other trade associations to challenge Vermont’s labeling mandate for Genetically Modified (GM) food products.  The law takes effect on July 1, 2016, and Vermont’s Attorney General recently adopted implementing regulations.  Under Vermont’s law, certain manufacturers and retailers will need to identify whether raw and processed food products sold in Vermont were produced in whole or in part using GM technology.  The law also prohibits the use of “natural”-type claims on GM food products.  GMA – together with the Snack Food Association (SFA), International Dairy Foods Association (IDFA), and National Association of Manufacturers (NAM) – challenged the law primarily on First Amendment, Commerce Clause, and preemption grounds.  The plaintiffs also sought a preliminary injunction in the case.
  • In an opinion issued on April 27, 2015, Judge Christina Reiss, Chief Judge of the U.S. District Court for the District of Vermont, has allowed Vermont’s law to stand for now, denying the plaintiffs’ motion for a preliminary injunction and dismissing specific counts related to the Commerce Clause and preemption-based challenges.  On a positive note for the food industry, the court found that plaintiffs are likely to prevail on their claim that the law’s ban on the use of “natural” claims for foods containing or possibly containing GM ingredients is unconstitutional.  In the context of the First Amendment challenge, however, the court held that Vermont’s labeling requirement does not warrant “strict scrutiny.”  In denying the plaintiffs’ motion for a preliminary injunction, the court did not appear to be persuaded that plaintiffs would suffer “irreparable harm” pending resolution by trial; instead, the judge concluded that plaintiffs had identified only “the ‘possibility’ of harm.”
  • Although several aspects of the plaintiffs’ challenge have survived the State’s Motion to Dismiss and proceed to a trial on the merits, it is very much an open question whether plaintiffs will be able to convince the court at trial to strike down the law.  In effect, the food industry still must wait in limbo, counting down to possible compliance on July 1, 2016…waiting to see if the federal government will intervene with its own labeling “fix”….waiting to see if other states will attempt to impose GM labeling requirements… and all the while continuing to hope for ultimate victory in the GMA challenge.

FDA takes enforcement action against BMPEA.

  • In recent weeks, we have seen increased media coverage regarding concerns about beta-methylphenethylamine (BMPEA) in dietary supplements in the United States.  Congressmen have urged FDA to take enforcement action and a major supplement trade association has imposed a “no-sale” policy for BMPEA supplements as a condition of membership.  Many have questioned the safety and the regulatory status of BMPEA for use as a dietary ingredient in dietary supplements.
  • FDA has now taken enforcement action, issuing Warning Letters to five companies marketing products that list BMPEA as a dietary ingredient.  FDA’s position is that BMPEA does not meet the statutory definition of a “dietary ingredient” permitted for use in dietary supplements.  By law, a dietary supplement is defined as a product intended to supplement the diet that bears or contains one of the following dietary ingredients:  a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.  According to FDA, “BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement.”  Further, two of the Warning Letter recipients identified the botanical Acacia rigidula as the source of the BMPEA, but FDA has conducted research establishing that BMPEA is not a constituent or extract of Acacia rigidula.  FDA considered specific products to be misbranded for that reason as well.
  • FDA’s enforcement actions in this space indicate that the Agency is taking a closer look at BMPEA and Acacia rigidula in dietary supplements, but several unanswered questions remain.  For instance, FDA’s Warning Letters make no mention of whether Acacia rigidula may appropriately be used as a botanical ingredient in dietary supplements.  If so, is it a new dietary ingredient requiring notification?  What is the full extent of the relationship between dietary supplements that contain Acacia rigidula and the masked presence of BMPEA?  The supplement industry and consumers alike are now on notice about the alleged dangers of BMPEA, but some speculate that bad actors simply will find other synthetic stimulants to market under the guise of botanical ingredients in the future.  The full ramifications of the BMPEA backlash remain to be seen.

FDA declares 2015, “the year of FSMA.”

  • Enacted in 2011, the FDA Food Safety Modernization Act (FSMA) is the most comprehensive food safety reform in the United States in over 70 years.  Numerous FSMA provisions require FDA rulemaking prior to implementation, and FDA has issued many major proposed rules at this point.
  • On April 23, 2015, FDA held a public “FSMA Kickoff Meeting” at which Agency officials provided updates on FSMA implementation, including a summary of key FSMA dates.
  • The key takeaway from FDA’s meeting was that the food industry should be preparing for FSMA compliance.  All proposed rules are due to be finalized within the coming year and nearly all food companies will be required to comply in less than five years (with compliance dates staggered in some instances based on the size of the business).

Kraft pledges to remove artificial colors and preservatives from flagship product.

  • In recent years, the food industry has faced media criticism related to the use of artificial ingredients in products sold in the United States, particularly where the same ingredients are not approved or have been discontinued in other countries due to alleged safety concerns.
  • Major food manufacturer Kraft has announced that it will replace artificial preservatives and synthetic colors in its “Original Kraft Macaroni & Cheese” product with ingredients derived from natural sources, such as paprika, annatto, and turmeric.  Food blogger, Vani Hari (the “Food Babe”) cites Kraft’s announcement as a victory, as she has been touting a petition to urge Kraft to discontinue the use of artificial colors Yellow #5 and #6.
  • FDA’s express approval of artificial ingredients like Yellow #5 and #6 unfortunately does not insulate the food industry from criticism or attacks by consumer groups, bloggers, and individuals.  We likely will continue to see more and more “voluntary removals” of controversial ingredients from the market — despite conclusive evidence of any safety concerns — as public pressure and social media continue to grow in their quasi-regulatory role.

Vermont’s Attorney General formally adopts rules to implement mandatory GM labeling law.

  • Vermont is the only state in the U.S. with an effective law that mandates the labeling of foods produced with genetic engineering.  Although the law is set to take effect on July 1, 2016, the Grocery Manufacturers Association (GMA) and other national food trade associations have challenged the law in court; the case is still pending.
  • In the meantime, Vermont’s Attorney General (AG) has formally adopted regulations to implement the mandatory labeling requirement.  The rules specify the scope of the labeling requirement and provide details regarding requirements for claim wording, prominence, and placement.
  • The food industry continues to await resolution of the legal challenge to Vermont’s labeling law; the disposition of that case likely will set the stage for future legislative action at the state and/or federal level.

EFSA publishes an overview report on chemicals in food for 2015.

  • As requested by the European Commission, the European Food Safety Authority (EFSA) published for the first time a report on chemicals found in food. This exercise will be repeated every year and will cover two topics:  (1) pesticide residues in food, and (2) veterinary drug residues in animals and food. Also, it will contain supplementary parts – this year EFSA analyzed arsenic levels found in food and drinking water, and ethyl carbamate levels in spirit drinks.
  • The report addresses chemical concentrations based on two annual reports (pesticide residuesand veterinary drug residues) as well as two ad hoc reports published during this period: one on arsenic in food and drinking water, and the other on ethyl carbamate in spirit drinks. The conclusions are as follows:
    • Pesticide residue levels in food have continued to decrease since 2012, and in 2013 only 1,5% of samples tested by EFSA exceeded the maximum residue levels for the EU. Organic food and baby-food possess the lowest pesticide residue levels, and the highest levels were found in tea leaves, peppers and tomatoes (among others). In its analysis EFSA used a model called PRIMo (the Pesticide Residue Intake Model) to estimate exposure of European consumers to pesticide residues. The expected exposure was then compared with guidance levels for acceptable exposure, known as toxicological reference values. This analysis brought EFSA to the conclusion that the probability of being exposed to pesticide residues at levels that pose a health risk is low in the short term. The long-term exposure estimates were concluded with a statement that residues, according to the current scientific knowledge, are not likely to pose a chronic health risk.
    • Compliance with maximum veterinary drug residues in animals and food has also increased steadily since 2007. The recent horsemeat scandal drew attention to the safety of meat. Accordingly, the use of veterinary drugs in food-producing animals was monitored very closely. The results of the studies showed that the situation is largely under control.
    • EFSA also spoke of organic and inorganic arsenic, residues of which can be found in some foodstuffs. EFSA analyzed the residues of two types of arsenic – inorganic and organic. Organic arsenic is considered less harmful for human health. Inorganic arsenic levels in the EU are still quite high in rice (white and brown). Therefore rice requires a thorough wash before cooking, as well as a large quantity of cooking water in order to reduce the arsenic concentration. 98% of Europe’s drinking water is under the EU limit for arsenic, except in territories with volcanic soils. Also, fish and seafood turn out to be a source of arsenic, but in those cases the arsenic occurs as the less harmful, organic form.
    • EFSA also notes that Ethyl carbamate levels in alcoholic beverages (that appear during food processing and/or storing and may cause cancer in humans) also appear to be on a downward trend since 2007.
  • The report is aimed at non-specialists and provides an overview of the available information. The overall outcome appears to be positive. The report has been welcomed with appreciation by the European Commission.  The acting Director General for Health and Food Safety, Ladislav Miko said: “This new report aimed at the European public translates complex scientific data on food in a more accessible and understandable way. I very much welcome this new way of reporting on issues that matter to people who are concerned about what’s in their food and hope we will see more of this type of food information from EFSA in the future.

Stakeholders call for action of the European Commission on trans fatty acids.

  • Members of the European Parliament (MEP) Heart Group, with the support of the European Society of Cardiology (ESC) and of the European Heart Network (EHN) organized a panel debate with representatives of the European Commission and WHO Europe to discuss the situation on trans fatty acids in the EU. The debate took place on April 15th, 2015.
  • Under the Regulation 1169/2011/EU the European Commission was to present by 13 December 2014 a report on the presence of trans fats in foods and in overall diet in the EU population. The report has not been issued so far. According to the press releases the Commission informed during the debate that it is considering how to handle the trans fats, i.e. whether to issue legislation that would ban the use of industrial trans fatty acids. The report by the Commission is due to be issued in June 2015.
  • Many stakeholders await the Commission’s report, as its findings may have significant ramifications both within and outside the EU.

Trade association proposes application of dietary supplement GMPs to raw material suppliers.

  • FDA’s current Good Manufacturing Practice (GMP) regulations in 21 CFR Part 111 apply to finished dietary supplements, but not directly to the raw materials or dietary ingredients used in their production.
  • In yet another development related to the New York Attorney General’s (AG) investigation into the marketing of herbal supplements, the Organic & Natural Health Association met with the AG’s office and proposed that the dietary supplement GMP regulations be expanded to encompass the production of raw materials (e.g., dietary ingredients) as well.
  • Organic & Natural plans to file a citizen petition to request that FDA expand the scope of the dietary supplement GMPs.  The CEO of Organic & Natural reportedly has not formally communicated with other dietary supplement trade associations regarding the scope of 21 CFR Part 111.  Organic & Natural’s proposal is unlikely to be without its detractors, but the full extent of industry support or opposition remains to be seen.

 

FSIS releases guidance on new technology notifications.

  • Under a longstanding policy, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has requested that meat, poultry, and egg producers (and their suppliers) notify the Agency of any “new technology” intended for use in official establishments and plants.  This notification gives the Agency an opportunity to determine whether the new technology requires a pre-use review.  Where new technology may affect product safety, FSIS regulations, inspection procedures, or inspector safety, FSIS will advise the submitter that a pre-use review is necessary.
  • FSIS has issued Compliance Guideline Procedures to provide guidance manufacturers and users of new technology on the preparation and submission of new technology notifications and protocols to the Agency.  The guidance clarifies the information that FSIS expects to see in a new technology notification, as well as the types of data that provide scientific support for the use of a new technology.  The guidance also specifies the elements that should be included in the protocol for any experiment used to support the use of a new technology.
  • A new technology is defined as a new, or new application of, equipment, substances, methods, processes, or procedures affecting the slaughter of livestock and poultry or processing of meat, poultry, or egg products.  This broad definition means that new technology issues affect numerous sectors of the supply and production chain, thus making the new FSIS guidance document potentially relevant to a significant swath of the food industry.

Congressmen urge FDA action against BMPEA in dietary supplements.

  • According to a recent study that has garnered media attention, some dietary supplements that purport to contain the herbal ingredient, Acacia rigidula, actually contain detectable amounts of the synthetic compound, beta-methylphenethylamine (BMPEA).  BMPEA apparently has not been studied in humans and thus, safety information for the substance is lacking.  Further, BMPEA does not have a clear regulatory status for its use as a dietary ingredient in dietary supplements at this time.
  • Following the release of the study, Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) sent a letter to FDA requesting that the Agency launch an investigation into, and take appropriate regulatory action against, products purporting to contain Acacia rigidula.
  • The dietary supplement industry appears somewhat supportive of the BMPEA backlash at this point, with one major trade association — the United Natural Products Alliance (UNPA) — imposing a “no-sale” policy for BMPEA supplements as a condition of membership in the organization.  Still, the media attention on BMPEA continues to keep the spotlight on the regulation and safety of dietary ingredients and dietary supplements, with even greater focus on herbal or botanical ingredients.

Consumer safety groups file extensive comments criticizing GRAS process.

  • In recent years, consumer groups have been attacking the “Generally Recognized as Safe” or “GRAS” exemption that permits the marketing of food substances in the United States without the need for FDA premarket approval.  GRAS opponents criticize FDA’s alleged lack of oversight and direct involvement in the marketing of GRAS substances.
  • On April 15, 2015, four groups — Center for Science in the Public Interest, Consumers Union, Environmental Working Group, and Natural Resources Defense Council — filed an extensive set of comments with FDA criticizing the GRAS process and urging the Agency to rein in the food industry’s reliance on the GRAS exemption to market food substances in the United States.
  • The contents of the comments likely will come as no surprise to the food industry, as they reiterate the same rhetoric that consumer groups have been sharing with the media for years, e.g., the “Generally Recognized as Secret” catchphrase.  Because Congress expressly codified the GRAS exemption in the law, it is likely that the debate will continue over whether the right solution — if indeed any “solution” is warranted here — will come from Congress, FDA, or voluntary food industry action.