FDA to Begin Inspections for Intentional Adulteration in March 2020

FDA recently announced that verification of compliance with the Intentional Adulteration (IA) rule will begin in March 2020. Addressing hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration. Those food facilities covered by the rule will be required to develop and implement a food defense plan, (which is part of the Food Safety Modernization Act (FSMA) requirements), identifying vulnerabilities and mitigation strategies for those vulnerabilities. Additionally, facilities will be required to ensure that the mitigation strategies are working. The first compliance date arrives in July 2019. EAS Consulting Group’s FSMA team can help assess current food defense strategies and strengthen those that do not meet FDA’s stringent requirements.

Final Rule on OTC Hand Sanitizers Issued

FDA issued a Final Rule, effective April 13, 2019, which aims to ensure the safety and effectiveness of OTC hand sanitizers, formally known as topical consumer antiseptic rub products. These products are intended for use without water and marketed under the FDA’s OTC Drug Review.

Active ingredients of ethanol, isopropyl alcohol, benzalkonium chloride, which the majority of hand sanitizer rubs on the market contain, have deferred action to allow for the ongoing study and submission of additional safety and effectiveness data to enable FDA’s safety determination for use in OTC consumer antiseptic rub products.  At this time, FDA states that it does not intend to take action to remove hand sanitizers containing these three active ingredients from the market and their status will be addressed either after completion and analysis of the studies or at another time, if these studies are not completed.

However, 28 other active ingredients, identified in the 2016 Consumer Antiseptic Rub proposed rule, including triclosan and benzethonium chloride, are no longer eligible for inclusion in any future OTC monograph.

This long awaited rule finalizes a June 30, 2016 proposed rule on consumer antiseptic rubs, where FDA requested additional scientific data to support the safety and effectiveness of active ingredients used in OTC consumer antiseptic rubs. FDA has determined that less than 3% of the marketplace will be affected by the issuance of this final rule, as most OTC consumer antiseptic rubs use ethyl alcohol as the active ingredient.

Concerned companies may contact EAS to learn more about how this Final Rule impacts product formulations and compliance with the OTC monograph.

Slack Fill – EAS Experts are Here to Help

There has been an increasingly growing volume of litigation in the slack fill area. This is a daunting issue for food manufacturers and is complicated by a dearth of clear guidance which ultimately leads to a lack of understanding of the many competing requirements and increases a company’s risk for legal challenges. In fact, there are at least five levels of law where one should look for guidance with slack fill, including international, federal, state, local and common law. Answers on how to interpret and piece the various laws and rulings together is not found on the FDA website, and moreover, it is very difficult to predict how a consumer attorney will interpret them as they attempt to bring suits against the industry.

If you are one of the many who have questions concerning how to find, understand, interpret and implement policies and practices regarding slack fill, call EAS’ team of experts who can assist in navigating this very complicated and confusing issue. 

FDLI Cannabis Conference Covers Possible Pathways to Regulation

The first annual FLDI Cannabis Conference was held in Washington D.C. on November 2nd. What made this cannabis conference unique for me was not the content or the speakers but the audience attending. I have been part of the cannabis industry for the past four years, from the start of recreational sales in Colorado in 2014, and I have attended many cannabis conferences. They are normally attended by science researchers and cannabis industry people.

However, the FDLI Cannabis Conference was attended by representatives of US federal agencies such as FDA, USDA, Department of Health and Human Services, NIDA, NIH, lobbying groups, think tanks, various large corporations both inside and outside (pharma and tobacco) of the current cannabis businesses and many attorneys. Unfortunately, there was very little industry representation.

The speakers and topics offered both scientific data from published studies and opinions of how the US federal government might regulate cannabis at some point in the future. There was a discussion of legalities currently in place and international treaties that prohibit the DEA from de-scheduling cannabis and hemp on a federal level. I think the industry would have benefited from participating in these discussions and providing their perspectives.

A very useful speaker was a researcher from University of Colorado who detailed the obstacles in her path to performing accredited, scientifically recognized research with cannabis when she only has one source of cannabis plant material, cannot use the university’s pharmacy department storage facilities or their brainpower and experience and cannot administer medication and must trust her subjects to report their use accurately. Study approval is by DEA and NIDA and often takes years to receive. It is commonly recognized that the US has fallen behind in the research and commercialization of cannabis. Israel is the global leader of cannabis research, while Canada leads in the commercialization of cannabis through federal legalization.

This is the only conference that I am aware of that has presented information about cannabis to federal agency representatives, which is a historic first. That said, the information was somewhat one-sided as it appeared those who currently own cannabis companies and work in the industry did not attend this conference. The FDLI Cannabis Conference is a wonderful opportunity to educate both the agencies that would regulate cannabis in addition to the industry on the regulatory issues and challenges. Only if the industry and regulators come together to discuss these very complex issues can progress be made. Perhaps we will see more industry participation next year.

There has been much discussion for the past year regarding the need for the US to find a federally legal way to ensure the safety of consumers and patients who use cannabis through some type of regulation while leaving the choice of participation to individual states. This past election saw the number of recreational states increase to 10 and medical states to 33. It appears that the time will be sooner rather than later, so hopefully, this conference is only the first which attempts to bring all of the parties together to engage in open dialogue to move these issues forward. As we move closer to federal GMP regulations, EAS Consulting Group will be ready to assist the cannabis industry with quality system implementation, laboratory operations, training, procedures and other compliance-related issues that they may face.

Are Plant-Based Proteins Milking Dairy?

By Allen Sayler, Senior Director for Food Consulting Services

When FDA announced recently that the agency is seeking public comment for standards of identity overhaul that will focus in part on plant-based products that are marketed as “milk” substitutes, manufacturers of those products as well as the consumers who enjoy them were left wondering how this review and any future changes would affect them. Consumers of soy, almond, rice, coconut and other plant-based “milk” enjoy these dairy alternative products for any number of reasons, but in some cases, their consumption decisions are based on incomplete or inaccurate information and may result in a diet deficient in certain nutrients found in dairy milk but not the substitute protein. This issue is of interest to others outside of the US as Canada, the European Union and Codex all have laws, regulations and beverage standards that limit the use of the term “milk” to only beverages where dairy “milk” is the major or characterizing ingredient.

There are nearly 300 standards of identity on the books at FDA, and these plant-based proteins which use qualified terms as part of their “milk”, “yogurt” and “cheese” product names aren’t in-fact “milk” as we have come to know it. Based on this technical violation of the standard of identity for “milk” and a concern regarding consumer misunderstanding of the nutritional value of plant-based beverages, FDA has decided to look at the term milk as part of its overall effort of modernizing standards of identity and improving information provided to consumers and their physicians so that the nutritional composition and benefits of products is clear.

FDA is currently seeking information on how consumers understand the term “milk” and whether the nutritional differences between dairy-based and plant-based “milk” products is understood. FDA is also trying to understand if the use of the term “milk” in non-dairy products is misleading and if that lack of understanding plays a role in less informed dietary choices. Stakeholder feedback is actively recruited by the agency and, based on initial comments gathered, FDA will provide an additional request for information in late summer or fall targeted more directly towards consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives, including a focus on nutritional impact. The agency will use this feedback to refine its policy for these standards of identity and will issue new guidance for industry as well as their compliance and enforcement approach (no timeline is currently established). 

In addition to gaining an understanding of milk products, the agency is additionally seeking feedback on how the agency should consider food technology, nutritional science, fortification practices and marketing trends for not only dairy but all foods as part of their standards of identity review to gain an understanding of how each may enhance or stymie innovation or nutritional improvements.

As manufacturers of foods, standards of identity can at times protect the consumer and food industry from misleading or fraudulent foods, food ingredients, and labels, but they can also hinder efforts at product innovation, use of new ingredients and processing technologies and restriction on modification of the standard to improve nutritional content. Understanding food labels, content, nutritional value and product claims are all critical for consumers to make informed choices today. It is equally important for food manufacturers, who are committed to providing cleaner food labels while trying to deliver more nutritionally sound food into the US marketplace.

Regulatory opportunities, headwinds, and challenges will be facing the Agency as it begins to review and potentially revise the current food standards of identity. As the agency seeks comment, now is the time for food firms to provide their input and begin the conversation as to how technology, fortification, and sound science need to be considered in the review and revision process, to the benefit of the consumer, food industry and FDA. As an innovation for a healthier food supply continues to evolve, the ability to clearly communicate an improved and clear message of food content and nutritional value will enhance consumer understanding and allow for more informed choices. Formulating agency feedback can help to effectively lead awareness of those opportunities and challenges. Incorporating sound scientific assessments, food processing technologies and market research on consumer perceptions and trends incorporated into well-written comments can enhance a firm’s position. EAS independent consultants, toxicologists, microbiologists who are experts in dairy, plant-based beverages and FDA food standards of identity and labeling can help you to formulate your position and develop agency comment.

U.S. CODEX Office Relocated Within USDA, New Opportunities for the Food Industry

The Codex Alimentarius Commission (Codex) is a United Nations food standards setting body working under the auspices of the Food and Agriculture Organization and the World Health Organization (WHO). The official mission of Codex is to protect consumers’ health and ensure fair practices in the food trade. Codex standards are relied upon by exporters to set a level competitive playing field. Many countries incorporate Codex standards into their national laws and Codex standards often serve as specifications within the international food trade. Codex standards, ranging from labeling requirements to lists of approved food additives, significantly affect the ability of food manufacturers to export their products around the world.

Since 1994, Codex food safety standards have also played an express role in settling trade disputes over unjustified trade barriers disguised as national food regulatory requirements. Under the World Trade Organization’s (WTO) Agreement on Sanitary and Phytosanitary Measures, nations that wish to apply stricter requirements than those set by Codex must justify those measures scientifically. Not surprisingly, trade disputes have long been intertwined with the Codex standard-setting process.

In response to such controversies, U.S. Secretary of Agriculture Sonny Perdue late last year moved the U.S. Codex Office from USDA’s Food Safety and Inspection Service (FSIS) to the Office of the Undersecretary for Trade and Agricultural Affairs led by Ted McKinney. Food companies and industry trade associations have overwhelmingly supported the decision.

Secretary Perdue announced the creation of the Undersecretary for Trade and Foreign Agricultural Affairs position while reviewing options for improving coordination on trade and international activities. As part of that process, Secretary Perdue determined that the U.S. Codex Office should be moved from FSIS to the new trade mission area. While the U.S. Codex Office mission remains the same, the move is significant.

Food companies and trade associations should take a new look at the agendas of key Codex Committees, http://www.fao.org/fao-who-codexalimentarius/committees/en/ to examine whether the U.S. government positions on specific points can be strengthened. A full list of all active Codex Committees can be found here, http://www.fao.org/fao-who-codexalimentarius/committees/en/. Each Codex committee is considering agenda items that will have an impact on U.S. exports.

Some draft Codex standards now under development are inconsistent with U.S. laws and regulations. For example, the agenda of the Codex Committee on Nutrition and Foods for Special Dietary Uses (which includes dietary supplements), http://www.fao.org/fao-who-codexalimentarius/committees/committee/en/?committee=CCNFSDU, has been particularly controversial in recent years, with the nitrogen to protein conversion factor issue pitting dairy interests against vegetable protein interests and the US against the EU in the areas of infant formula and other special dietary food standards. The agenda for the November 2017 meeting can be found at http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-720-39%252Fnf39_01_rev1e.pdf.

Food manufacturers may also wish to keep a special eye on the Codex Committee on Food Labeling, http://www.fao.org/fao-who-codexalimentarius/committees/committee/en/?committee=CCFL. Canada, which hosts and chairs the Committee on Food Labeling, http://www.fao.org/fao-who-codexalimentarius/committees/committee/en/?committee=CCFL, is formally proposing its own national regulations for front-of-pack nutrition rating symbols, https://www.canada.ca/en/health-canada/programs/consultation-front-of-package-nutrition-labelling-cgi/summary-of-proposed-amendments.html. The issue has already been placed on the agenda for the Codex Committee on Food Labeling, http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-714-44%252FWD%252Ffl44_01e.pdf. In contrast to Canada, the U.S. Food and Drug Administration (FDA) supports a voluntary front-of-pack nutrition-labeling program developed by the Grocery Manufacturers Association and the Food Marketing Institute.

The U.S. Codex Office regularly announces public meetings, held in the Washington, D.C. area, to formulate the position that the U.S. government will take at Codex meetings held in the U.S. and overseas. Companies and trade associations have an opportunity to express their views to USDA, FDA, Office of the U.S. Trade Representative, and other relevant U.S. government agencies. https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/us-codex-alimentarius/public-meetings. Participants can offer comments in written or oral form and speak directly with leading U.S. government officials that will attend official Codex meetings.

For example, on March 15, 2018, a U.S. government preparation session for the forthcoming meeting of the Codex Committee on Pesticide Residues was held in the Washington metro area, https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/us-codex-alimentarius/committees-and-task-forces/general-subject-committees/codex-committee-on-pesticide-residues/ct_index.

Other open meetings of the U.S. government delegation to Codex committee meetings will follow later this year. In addition to the Codex Committee on Nutrition and Foods for Special Dietary Use, and the Codex Committee on Food Labeling, key Codex committees include the Codex Committee on Food Additives http://www.fao.org/fao-who-codexalimentarius/committees/committee/en/?committee=CCFA, with over 400 food additives being considered for inclusion or deletion including those for fish, chocolate, wine, a number of dairy products. Also anticipated is an initial resolution of a stalemate between the EU block and the US and its allies on a significant number of colors and sweeteners, stalled from adoption for almost 6 years. The November 2017 report of the Codex Committee on Food Hygiene can be found at http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-712-49%252FReport%252FREP18_FHe.pdf, with significant rewrites of a number of Codex Hygiene documents including the HACCP Appendix for the Codex General Principles for Food Hygiene. The upcoming agenda for the Codex Committee on Contaminants in Foods and be found at http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-735-12%252FINV-PA%252Fcf12_01e.pdf, with lead levels and dioxins in foods, among a number of important topics to be discussed.

The relocation of the U.S. Codex Office within USDA to the new office for the Undersecretary for Trade and Agricultural Affairs should strengthen the new Administration’s commitment to international trade by providing a broader platform and US presence within the Codex “world” in order that global food standards are supportive and do not hinder US food exports, as they have sometimes done in the past. It’s housing within Trade and Agricultural Affairs should enhance ongoing dialogue and understanding about food regulatory matters domestically and worldwide. US-based food companies and their supporting trade associations should take advantage of this new opportunity and become more active in those Codex issues impacting their food sector by becoming strong Codex advocates and make their views known.

For more information, contact Allen Sayler, Senior Director of Food Consulting Services at asayler@easconsultinggroup.comor 571-447-5509.

EAS and FoodMinds Offer Strategic Solutions to Food Industry Nutrition Marketing Challenges

EAS has teamed up with FoodMinds to offer food firms a new solution to the many product and marketing challenges of this highly regulated and litigious climate. From acceptable claims to new requirements for compliant labels, to how products are marketed, the industry is faced with new challenges daily. EAS and FoodMinds combine the best in regulatory and marketing talent to develop a targeted approach for promoting brand awareness and integrity while meeting the many federal requirements of FDA and/or USDA and FTC. Learn more about this collaboration by reading our Press Release and learn more about how this collaborative effort can benefit your organization.

What’s New at FDA

The Center for Food Safety and Applied Nutrition has released the 2017 Food Code Book which includes science-based guidance for reducing known risks of foodborne illness. Originally designed for foods offered at the retail and food service locations, it has been widely adopted by the state, local, tribal and territorial regulatory agencies that regulate restaurants, retail food stores, vending operations and food service operations in schools, hospitals, nursing homes, and child care centers. EAS Consulting Group offers services to the retail and food service industries and would be glad to discuss your specific questions on regulatory compliance and enhanced food safety. Contact Allen Sayer, Senior Director of Food Consulting Services at asayler@easconsultinggroup.com

USDA has launched a new a new electronic data platform that includes Market News Information by commodities such as dairy, fruits and vegetables, livestock and tobacco. The platform also includes resources which are of interest to USDA and FDA regulated industries, such as the pesticide data program, organic reports, and food safety. EAS would be glad to help you to better understand data found them in the reports and how they pertain to your business. Contact Allen Sayler at asayler@easconsultinggroup.com