Statements

IFAC Statement on U.S. Food and Drug Administration Final Rule Regarding Substances Generally Recognized as Safe

On August 17, 2016, the U.S. Food and Drug Administration (FDA) published a final rule regarding substances that are “generally recognized as safe” or GRAS. This rule formalizes the steps food manufacturers must take to ensure GRAS substances are safe for human consumption and reaffirms a process that has worked extremely well for many years. The FDA has created a number of resources to help stakeholders comply with the rule, including a frequently asked questions (FAQ) document that was updated in October 2016 to incorporate provisions of the final rule. A copy of the FAQ is available here while other FDA GRAS resources are available here.

The rule finalizes a 1997 proposed rule that replaced the GRAS affirmation process with the GRAS notification procedure, under which the industry has been operating for nearly 20 years. The final rule codifies many of the concepts found in the proposed rule and does not represent a major shift in FDA’s thinking or regulatory policies towards GRAS substances. In fact, the final rule mandates many of the common procedures that International Food Additives Council (IFAC) members were already conducting voluntarily under the proposed rule. As such, the final rule includes many useful clarifications and procedures that IFAC members strongly support. While it does not fundamentally alter the GRAS concept or create over burdensome requirements, it provides a clearer explanation of how general recognition of safety is demonstrated under the law, what is expected when a company makes a GRAS determination and what companies must do when submitting a GRAS notification to the Agency for review.

The GRAS concept, which is rooted in the 1958 Food Additives Amendment to the Food, Drug and Cosmetic Act, is intended to address ingredients that have a long history of use or where a general recognition of safety exists in the public domain. Over the last two decades, FDA’s proposed GRAS notification system has evolved and the quality and rigor of GRAS notifications have also generally improved. Most manufacturers that have submitted a GRAS notification under the proposed rule will not find much in the final rule that is new or that FDA has not previously communicated to submitters. However, as the final rule becomes effective on October 17, 2016, IFAC notes the following highlights and key differences between the proposed and final rules which are intended to help IFAC members and their customers navigate the requirements of the final rule:

  • The final rule defines the following terms (among others) which were not defined in the proposed rule: “GRAS,” “GRAS notice,” “notified substance,” “notifier,” “qualified expert” and “supplement.”
  • While the proposed rule suggested that GRAS notifiers could incorporate into a GRAS submission data and information previously submitted to the Agency, the final rule makes it expressly clear that such information can be incorporated.
  • FDA makes it clear in the final rule that the Agency would like GRAS submissions to be more uniform in format. As such, the final rule specifies that GRAS notifications must contain seven parts and lays out the information that is needed in each part.
  • To provide greater clarity regarding a notified substance, the Agency now requires that an “appropriately descriptive term” of the notified substance be submitted rather than the “common or usual name” (as was included in the proposed rule).
  • The final rule now includes a requirement that the notifier must identify any data or information in the notice that should be exempt from disclosure under the Freedom of Information Act (FOIA) (e.g., trade secret, commercial or financial information that is privileged or confidential).
  • To avoid incomplete submissions and ensure that all submissions accurately reflect all information about the substance, the final rule expressly requires that the notice be signed to certify that is complete, representative, and balanced. Balanced means it must include favorable and unfavorable information known to the notifier and pertinent to the evaluation of the safety and GRAS status of the use of the substance. While this was common practice under the proposed rule, it is now mandatory.
    • In regard to information that may not support GRAS status, the final rule requires that the submitter either: (1) Identify, discuss, and place in context, data and information that are, or may appear to be, inconsistent with the conclusion of GRAS status; or (2) state that the notifier has reviewed the available data and information and is not aware of any data and information that are, or may appear to be, inconsistent with the conclusion of GRAS status.
    • This implies that the submitter must be thorough in his or her review of the body of literature and include reference to any information that could be relevant to the determination in the notification.
  • The final rule also explicitly states that source information including applicable data and information at the sub-species level (e.g., variety, strain) for a notified substance of natural biological origin be provided. This is in addition to genus and species information that was noted in the proposed rule. This reflects FDA’s current thinking on the issue and is consistent with other FDA documents such as the revised draft guidance on New Dietary Ingredient Notifications.
  • Greater clarity is provided in regard to what must be provided to describe the manufacturing method. FDA now requires a description of sufficient detail to evaluate the safety of the notified substance as manufactured; trade secret information may be included so long as it is clearly marked as confidential and not subject to FOIA disclosures.
  • The final rule expressly requires relevant information on the physical or other technical effect the notified substance is intended to produce when necessary to demonstrate safety, including the quantity of the notified substance required to produce such effect. This information was generally provided in notices under the proposed rule, but is now mandatory.
  • In order to help FDA calculate the impact on dietary exposure of the intended use of the substance, the final rule expressly requires the notifier to consider dietary exposure, regardless of whether the conclusion of GRAS status is through scientific procedures or through experience based on common use in food. The final rule also creates two distinct parts for dietary exposure:
    • Part 3, which addresses how much of the notified substance consumers would eat as part of the total diet (including exposure from its intended use and all sources in the diet), as well as how much consumers would eat of other substances (e.g., contaminants or byproducts); and
    • Part 6, which requires the submitted to address the safety of the notified substance, considering all dietary sources and taking into account any chemically or pharmacologically related substances in such diet.
  • While notifications under the proposed rule commonly included a “comprehensive discussion,” the final rule requires a narrative (Part 6 of a GRAS notice), and a list of supporting data and information (Part 7 of a GRAS notice). The narrative is intended to provide FDA with greater understanding of the basis on which the GRAS conclusion is being made.
  • In the narrative, FDA also requires an explanation of how there could be a basis for a conclusion of GRAS status if qualified experts generally do not have access to non-public, safety related data and information.
  • The final rule also provides greater clarity in regard to the review process itself. For example:
    • The final rule permits the notifier to submit a timely “amendment” to a GRAS notice before FDA makes a determination and allows the notifier to ask FDA to cease review.
    • It also states that FDA will conduct an initial evaluation of the submission to determine whether to file it as a GRAS notice for evaluation within 30 days as specified in the proposed rule. In the proposed rule FDA was only obligated to acknowledge receipt.
    • When a submission is filed as a GRAS notice, FDA is required to send a letter informing the notifier. If a submission is not filed, FDA will must inform the notifier and provide reasons for not filing the submission as a GRAS notice.
    • FDA is obligated to respond to the notifier within 180 days of filing (as opposed to 90 in the proposed rule) based on FDA’s evaluation of the notice. FDA may extend this response window by 90 days on an as needed basis. If extended FDA will inform the notifier “as soon as practicable” but no later than within 180 days of filing.
    • If FDA ceases review or responds to a submission, the notifier is entitled to submit a “supplement” to a GRAS notice addressing the FDA response.

IFAC and its member companies strongly supports this final rule and believes its requirements largely reflect industry best practices under the 1997 proposed rule. However, the final rule brings certainty and clarity about FDA’s expectations for GRAS determinations and notifications to the Agency. IFAC continues to be very supportive of GRAS, which represents the pinnacle of public and private sector collaboration, but also supports FDA’s continued efforts to strengthen the process. Further, IFAC welcomes forthcoming Agency guidance documents intended to clarify its interpretation of what it means for a substance to be GRAS and minimize conflicts of interest in GRAS expert panels. GRAS offers industry and FDA many benefits and shifts the resource burden of determining safety of some substances to industry while allowing FDA resources to be directed at activities that have the greatest impact on public health, such as implementing the FDA Food Safety Modernization Act. The GRAS process, and this final rule, provides a clear legal framework under which food manufacturers can bring innovative, safe food and beverage products to market to meet consumer demands.

IFAC and its members look forward to working with FDA and other stakeholders to implement this final rule and achieve our common goal of maintaining the safest food supply in the world. Moving forward, all stakeholders should make GRAS conclusions and submit GRAS notifications following FDA’s final rule. To help companies navigate future submissions, IFAC is updating its GRAS Best Practices Guide to include all of the requirements in the final rule. The updated GRAS Guide will be made available in the near future.

 

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IFAC and IDF sign Memorandum of Understanding

Washington DC, and Brussels, October 17, 2016 — The International Food Additives Council (IFAC) and the International Dairy Federation (IDF) signed a Memorandum of Understanding (MOU) to promote the global harmonization of food additives and food ingredients for milk and milk products.

Specifically, IFAC and IDF have agreed to cooperate in submitting relevant science-based information and positions to intergovernmental organizations such as Codex Alimentarius. In addition, the organizations will exchange relevant information and collaborate in aligning communication efforts relating to food additives and ingredients affecting the dairy sector. Providing technical assistance regarding global specifications as well as the interpretation and implementation of regulations is also within the scope of the agreement.

“The dairy industry is very important to IFAC members,” said Robert Rankin, Executive Director of IFAC. “Many dairy products contain ingredients produced by IFAC member companies, so this partnership with IDF will help enhance our visibility within the dairy industry and facilitate alignment on key issues facing our industries, organizations and ultimately, consumers.”

“It is critical for the dairy sector to be proactively involved in the setting of international standards given the impact on safeguarding consumer health and safety, protecting the environment, facilitating the global trade of milk and milk products and supporting sustainable economic growth” said Dr. Nico van Belzen, Director General of IDF. “IDF’s strategy includes an objective to develop collaborations with relevant organisations to create synergies and increase effectiveness in international harmonization of standards affecting the dairy sector. The collaboration with IFAC is a close fit with this strategy.”

IFAC logo

About IFAC

The International Food Additives Council is a global association representing manufacturers of food ingredients. Founded in 1980, IFAC strives to promote science-based regulation and the global harmonization of food ingredient standards and specifications. For more information about IFAC visit www.foodadditives.org

IDF-logo

About IDF

The International Dairy Federation provides science-based information to its National Committees as well as to international organizations, governments and legislators. IDF places great emphasis and importance on ensuring that the work conducted by its Standing Committees and Task Forces is of the highest scientific quality and integrity and is relevant and applicable to the entire dairy sector and industry worldwide. For more information, visit www.fil-idf.org.

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IFAC CONTACT:

Randy Spoon

+1 678 303 3017

rspoon@kellencompany.com

 

IDF CONTACT:

Apolina Fos

+32 2 325 67 40

afos@fil-idf.org

 

New study proves no adverse effects of carrageenan in human cells

WASHINGTON, D.C. (August 10, 2016) – A new study on carrageenan, an ingredient key to delivering stability, texture and nutrients in many foods and beverages, clearly demonstrates that the ingredient does not induce inflammation in human cells as claimed by carrageenan critics.  The study, which was conducted by internationally recognized toxicologist and carrageenan expert Dr. James M. McKim, Jr., was recently accepted for publication by the peer-reviewed journal Food and Toxicology. This pivotal study represents the culmination of two years of research that was unable to replicate any of the findings of carrageenan critics, including Dr. Joanne Tobacman, who claim the food ingredient contributes to certain adverse health outcomes.

Publication of McKim’s study raises major questions about the validity of Tobacman’s conclusions and underscores the importance of replicating scientific results in different laboratories and by multiple researchers. McKim’s research was carefully designed to investigate several recent studies Tobacman has cited as evidence of her claims that carrageenan causes inflammation and is harmful. Not only was McKim unable to replicate the negative effects Tobacman has reported, his research showed carrageenan has no measurable effects on cells and provides strong evidence that carrageenan consumed in foods and beverages would not cause inflammation in humans.

“Dr. McKim’s research confirms what we have known for decades—carrageenan has no impact on the human body when consumed in food,” said Robert Rankin, Executive Director of the International Food Additives Council (IFAC), which commissioned the study. “Carrageenan producers have taken very seriously claims that the ingredient is unsafe, thoroughly investigated the research supporting those claims and found them to be baseless.”

Carrageenan is a common food ingredient used in many foods, such as ice cream, chocolate milk, yogurt and soy milk, for its stabilizing and thickening properties. It is also an approved additive for use in infant formula, where it is ensures that essential nutrients remain mixed throughout liquid products. It occurs naturally in red seaweed that is grown and harvested sustainably by tens of thousands of family farmers around the globe. Carrageenan is popular as a plant-based, eco-friendly alternative to animal-derived thickeners and has been used safely in foods for hundreds of years.

McKim’s study comes just months before the U.S. National Organic Standards Board (NOSB) is expected to vote on whether to reapprove the use of carrageenan in organic foods sold in the United States. Groups touting Tobacman’s research have lobbied the U.S. Food and Drug Administration to ban carrageenan in all foods and the NOSB to remove it from organic products. Despite these efforts, regulatory bodies around the world have repeatedly reviewed and dismissed their claims, finding carrageenan to be safe for use in all foods.

McKim’s research exposes fundamental flaws in Tobacman’s evidence, adds to the vast body of scientific research demonstrating carrageenan safety and thoroughly debunks certain groups’ claims that carrageenan is harmful and should be removed from foods. For more information about carrageenan and other ingredients and additives used in food production, please visit www.foodingredientfacts.org.

About IFAC

The International Food Additives Council (IFAC) is a global association representing manufacturers of food ingredients. Founded in 1980, IFAC strives to promote science-based regulation and the global harmonization of food ingredient standards and specifications.

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Contact:
Randy Spoon

678-303-3017

rspoon@kellencompany.com

To view the complete study, click here.

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IFAC Statement on Claims Linking Emulsifiers to Negative Gastrointestinal Health Outcomes

Safety is and always will be the number one priority of members of the International Food Additives Council (IFAC). The food ingredients IFAC members produce have been determined to be safe by regulatory authorities and are consumed by billions of people every day around the world. As a result, IFAC is working diligently to understand the implications on human populations of the findings of research, including a 2015 study by Chassaing et al., which has examined how food ingredients interact with GI microbiota. Potential effects of dietary constituents on the human microbiome is a complex and emerging area of study, but an important one for further research given the emerging evidence and the importance of the microbiome on human health.

However, IFAC has very serious concerns about the validity of broadly extrapolating the results observed by Chassaing et al. in mice to human populations. Based on IFAC’s review of the research, there is no cause for concern at this time that CMC, P80 or other emulsifiers are unsafe for human consumption or should be removed from products. IFAC is committed to fully investigating this subject, but current understanding of the safety of CMC, P80 and other emulsifiers do not substantiate claims that Chassaing et. al. make on the effects observed in mice and whether the findings in the study have any relevance in humans or that the substances studied in mice have similar impacts when consumed by humans in food. Without more scientific substantiation of the Chassaing et al. results, the overwhelming scientific consensus is that all of these materials remain safe and consumers and users should feel confident using and consuming them.

In February 2015, the Journal Nature published a study, “Dietary emulsifiers impact the mouse gut microbiota promoting colitis and metabolic syndrome” by Chassaing et. al, in which the authors allege that carboxymethylcellulose (CMC) and/or polysorbate-80 (P80) may negatively impact gut microbes and are the cause of several adverse health impacts in humans, including inflammation of the gut and symptoms associated with colitis, metabolic syndrome, and other chronic inflammatory diseases.

In the study, mice were fed water and feed supplemented with CMC or P80. Through analysis of feces and gastrointestinal (GI) tissue, the researchers found that CMC and P80 altered the composition of the microbiota in both the feces and intestines of the mice adversely impacted the mucosal layers of the mouse intestinal lumen. Based on the results, the researchers extrapolated their observations in mice to suggest the possibility that dietary emulsifiers “may have contributed to the post-mid-twentieth century increase in incidence of inflammatory bowel disease, metabolic syndrome, and perhaps other chronic inflammatory diseases.”

A number of media outlets reported on these allegations stemming from broad extrapolations simplifying the complex study to claim that the research demonstrates a link between human consumption of CMC, P80 and, in some cases, all emulsifiers and negative GI health outcomes, obesity, diabetes and other inflammation related diseases.

 

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