FDA’s Final Guidance for preparation of Food Contact Notifications for substances that come into contact with infant formula and human milk is intended to help industry understand FDA’s process for evaluating the safety of food contact substances. It incorporates the latest scientific thinking about the effects chemical substances may have on infant health. If you missed the recent EAS webinar on infant formula submissions, you may find it On-Demand. If you have specific questions about this Guidance, development of infant formula products, including GRAS submissions, or submission of a Food Contact Notification contact EAS.
Voluntary recalls are a vital means to protect public health and typically are the quickest way to remove defective or potentially harmful food, medical, and consumer products from the market. FDA’s new Draft Guidance includes steps companies may take to plan, prepare and initiate a voluntary recall in the event of a problem. The Guidance includes information on employee training, record keeping and written procedures for executing a recall. Companies in need of assistance in developing these tools or who feel a voluntary recall is warranted may contact EAS for assistance.
FDA has issued Final Guidance related to drug marketing application submissions for human drugs and recommendations for considerations of whether to submit a 501(b)(2) New Drug Application, commonly referred to as an NDA, or a 505(j) Abbreviated New Drug Application, commonly referred to as an ANDA. These are two of the four available pathways for drug submissions for FDA approval, with ANDA known as an abbreviated pathway.
While an NDA is required for all new drug products, administration routes, etc, an ANDA may be an appropriate submission for products which duplicate a previously reference listed drug (RLD) that FDA has already determined is safe and effective. In such cases where the active ingredient(s), dosage form, route of administration, strength, previously approved conditions of use, and labeling (with certain exceptions) mimic that of a RLD, an ANDA may be appropriate. ANDAs must still include full investigative reports of safety and effectiveness, and may also rely on FDA’s previous finding of such to the extent that the proposed drug shares the same characteristics as the RLD.
It is important to note that in cases where an ANDA is the appropriate submission choice, FDA will reject a 501(b)(2) application as a duplicate of an RLD. Therefore, a thorough consideration of the drug under submission compared to RLDs already approved by FDA is warranted. Firms wishing to outsource this review and seek recommendations on the appropriate FDA filing are invited to contact Bryan Coleman, Senior Director of Drugs and Medical Devices.
The recently signed Farm Bill answers a number of questions, particularly for those manufacturers of single ingredient foods, jars of honey and maple syrup specifically, who objected to the requirement in FDA’s 2016 Final Rule of adding a declaration of daily value (DV) for added sugars as misleading. Single ingredient products no longer require an added sugar declaration on the label.
FDA released a technical amendment correcting or further explaining minor errors and omissions in the May 27, 2016, Final Rules for Food Labeling: Revisions of the Nutrition and Supplement Facts Labels and Food Labeling: Serving Sizes of Foods that Can Reasonably be Consumed at One-Eating Occasion. These latest technical corrections are considered administerial in nature. Should you have any questions on these or other labeling issues please contact us for assistance.
FDA has released an updated version of the downloadable Food Safety Plan Builder tool designed to help owners and operators of food establishments with the development of a food safety plan that identified hazards requiring preventive controls to prevent foodborne illnesses specific to their facilities. All Food Safety Plans must contain those components that are needed to be in compliance with the 21 CFR part 117, or “CGMP & PC for Human Food rule” requirements in Subpart C – Hazard Analysis and Risk-Based Preventive Controls. A Food Safety Plan is a set of written documents that are based on food safety principles and incorporates hazard analysis and preventive controls, including supply-chain programs and a recall plan; and delineates the procedures to be followed for monitoring, corrective actions, and verification. Those wishing to use the FSPB as their primary tool may wish to have a qualified third-party, such as EAS, review the plan for adequacy.
Before 2016, FDA regulations for nutrition labeling did not define the term “dietary fiber” but in 2016, FDA issued regulation defining dietary fiber as two types of fiber:  non-digestible soluble and insoluble carbohydrates and lignin that are intrinsic and intact in plants; and  isolated or synthetic non-digestible carbohydrates determined by FDA to have acknowledged beneficial physiological effects. The FDA regulation listed 7 ingredients that had been found to have a beneficial physiological effect.
On June 14th, 2018, a little over 18 months before the compliance date for the new nutrition labeling, FDA issued two guidance documents regarding how isolated or synthetic non-digestible carbohydrates relate to the dietary fiber declaration. These guidance documents resolve nearly two years of uncertainty for at least 26 non-digestible carbohydrates under FDA review for their potential beneficial physiological effect.
FDA stated in one guidance document that the agency had found a beneficial physiological effect for 8 more ingredients and would use enforcement discretion to allow manufacturers to immediately reevaluate their fiber ingredients for inclusion in the dietary fiber declaration. The second document contained the scientific evaluation of data showing a beneficial physiological effect for those 8 ingredients.
The list of FDA-approved isolated or synthetic non-digestible carbohydrates with acknowledged beneficial physiological effects now include the following 15 substances:
- [beta]-glucan soluble fiber (as described in 101.81(c)(2)(ii)(A))
- psyllium husk (as described in 101.81(c)(2)(ii)(B))
- guar gum
- locust bean gum
- mixed plant cell wall fibers
- inulin and inulin-type fructans
- high amylose starch (resistant starch 2)
- resistant maltodextrin/dextrin.
The agency describes “Mixed plant cell wall fibers” as a large group of fibers that include cellulose, pectin, β-glucan, and/or arabinoxylan. FDA listed several examples of ingredients that include these fiber components, including apple fiber, citrus fiber, pea hull fiber and many others.
With the evaluation decisions in the new guidance, the list of 26 non-digestible carbohydrates under FDA evaluation as dietary fiber has now been shortened to 9. The ingredients where no determination has been reached include commonly used fibers such as gum acacia, carboxymethylcellulose, karaya gum, pullulan, xanthan gum and some other starches.
With the publication of these new documents, firms are encouraged to verify whether the updated guidance affects the dietary fiber declaration of their products. Nutrition information in recently created Nutrition Facts and Supplement Facts panels might need to be updated. EAS consultants are available to assist in evaluating ingredients in light of the new guidance and revising labels accordingly.
The names of new and returning members of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) have been announced and the committee now includes two EAS Independent Consultants. Returning member, Dr. Omar Oyarzabal who is a professor at the University of Vermont and newly elected member, Dr. Kathy Glass, a professor at the University of Wisconsin at Madison. The NACMCF was established in 1998 by the USDA’s Food Safety and Inspection Service (FSIS), the U.S. Department of Health and Human Services, Food and Drug Administration, Centers for Disease Control and Prevention, the Department of Commerce’s National Marine Fisheries Service, and the U.S. Department of Defense and the committee provides impartial scientific advice on issues pertaining to food safety. Says Sonny Perdue, US Secretary of Agriculture, “The committee members represent a diverse group from academia, consumers, the food industry, laboratories, consultants and government agencies, all of which play an important role in providing scientific advice and expertise to USDA on food safety and wholesomeness.”
A new section of the FDA Data Dashboard has been launched to help importers and manufacturers/processors meet supply-chain requirements under the FDA Food Safety Modernization Act (FSMA) by helping them more easily find compliance and enforcement information related to specific firms. Three of the FSMA rules contain supply-chain requirements: the Foreign Supplier Verification Programs rule, the Preventive Controls for Human Food rule, and Preventive Controls for Animal Food rule.
The Data Dashboard allows users to search multiple databases. The data used to generate the dashboard graphs and search results are based on data already available to the public through the FDA.gov website. The datasets and data include the Inspections Database, Recalls, Import Alerts and selected data elements from the compliance and enforcement related information on FDA.gov. Additional data will be included in future releases of the Dashboard. You may find the location and additional information about each dataset and other data sources by clicking on the Compliance Dashboards or FSMA Data Search options above.
To assist with the evaluation process, FDA created a Supplier Evaluation Resources page to help importers and manufacturers/processors find relevant compliance and enforcement information for their suppliers, but that page required them to search multiple databases.
EAS Consulting Group would like to bring to your attention an FDA Center for Tobacco Products announcement regarding updates to the Provisional Substantial Equivalence review process. Substantial equivalence (SE) is the most commonly used pathway by which tobacco products may obtain premarket authorization. Whether SE reports were submitted Provisionally, (products introduced into commercial distribution between February 15, 2007, and March 22, 2011) or are now submitted Regularly (SE Reports received after March 22, 2011), manufacturers must demonstrate that their new products have the same characteristics as a predicate product, or that any differences do not cause the new tobacco product to raise different questions of public health.
EAS Consulting Group offers a wide range of regulatory services. For assistance with dietary supplement and tobacco questions, including preparation of TPMPs, please contact our Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. at 571-447-5510 or firstname.lastname@example.org.
FDA recently responded to a letter from congressional representatives regarding product safety in the dietary supplement industry. In the letter, dated April 12, 2018, the agency states that safety, product integrity, and informed decision-making are the prioritization factors used to determine enforcement and regulatory strategies for the dietary supplement industry which is now a $40 Billion market with up to 80,000 products through a supply chain that includes approximately 7,000 facilities.
The agency stressed that the review of Serious Adverse Events, New Dietary Ingredient notifications, and work with the FTC to remove product and companies from the market that contain undeclared pharmaceutical ingredients and other adulterants when found through inspection, label compliance reviews, and market surveillance is key.
This was sent in a letter to Congressional Representative Andy Harris from MD, Derek Kilmer from WA, and David Young from IA who had previously requested that FDA describe its role and current progress in dietary supplement enforcement and regulation. It is a great glimpse into the current thinking of the Office of Dietary Supplements.
FDA released Guidance for Industry on highly concentrated caffeine in dietary supplements. FDA considers products which only or primarily consist of pure or highly concentrated caffeine and are sold as dietary supplements to be adulterated under section 402(f)(1)(A) of the FD&C Act [21 U.S.C. § 342(f)(1)(A)] due to the significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling or, if no conditions for use are suggested or recommended, under ordinary conditions of use. These products which have been linked to at least two deaths in recent years are considered to present a significant public health threat.
At TMAs 103rd Annual Meeting held on Tuesday, April 10, 2018, Dr. Zeller confirmed that FDA is actively working on a number of priorities that he called “Foundational Rules and Guidances”. This includes the issuing of the Tobacco Product Manufacturing Practice (TPMP) Rule which is required by Section 906(e) of the Tobacco Control Act addressing Good Manufacturing Practice (GMP) Requirements, which the FDA now calls TPMPs. Mr. Zeller made it clear that the FDA is “hard at work” on this rule.
When asked about when the industry can expect this Foundational Rule and Guidance for TPMPs to be issued by the FDA, Mr. Zeller declined to comment on a specific timeline, however, he did stress that the rule, along with the other foundational rules and guidance, is a priority for CTP. FDA is actively working on these and is committed to issuing the TPMP rule as soon as possible.
The tobacco industry should begin prioritizing manufacturing and quality processes assessments to begin preparing for and implementing quality systems, manufacturing controls, documentation, and SOPs. Based on Mr. Zeller’s presentation, the impending issuance of Tobacco TPMPs in conjunction with FDA’s new priorities indicates this preparation should begin sooner rather than later.