• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains

    Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality

    Nutrition and Flavor: Formulating for Modern Product Preferences

    What Do Consumers Know About the Gut Microbiome?

    How Will the European Green Deal Impact Dietary Supplements?
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise

    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    Exclusives
    Blogs & Guest Articles
    Health E-Insights
    Area Code 420
    eBook
    Antioxidants
    Dairy-Based Ingredients
    Enzymes
    Fatty Acids
    Fiber & Carbohydrates
    Green Foods
    Herbs & Botanicals
    Marine Nutraceuticals
    Minerals
    Omega 3s
    Probiotics & Prebiotics
    Proteins, Peptides, Amino Acids
    Sweeteners
    Vitamins

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise

    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression

    Fact or Myth: Antioxidants Negatively Impact Iron Absorption

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    Consumer Trends
    Contract Manufacturing
    Cosmeceuticals / Nutricosmetics
    Delivery & Dosage Technologies
    Dietary Supplements
    Flavors & Colors
    Functional Foods & Beverages
    Healthcare Trends
    Medical Nutrition
    Mergers & Acquisitions
    Natural/Organic
    Nutrition Bars
    Packaging
    Pet Nutraceuticals
    Quality & Safety
    Regulations
    Research
    Testing
    World Markets

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise

    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression

    Fact or Myth: Antioxidants Negatively Impact Iron Absorption

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    Bone & Joint Health
    Cancer Risk
    Cardiovascular Health
    Cognitive Function
    Diabetes & Blood Sugar Management
    Digestive Health
    Energy
    Eye Health
    Healthy Aging
    Immune Function
    Infant & Children's Health
    Inflammation
    Men's Health
    Mood Health & Sleep
    Oral Health
    Sexual & Reproductive Health
    Skin Health
    Sports Nutrition
    Weight Management/Weight Loss
    Women's Health

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise

    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Gencor

    Atlantia Clinical Trials

    Aiya America, Inc. (Aiya Matcha)

    Verdure Sciences

    KLK OLEO
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Gencor

    Atlantia Clinical Trials

    Aiya America, Inc. (Aiya Matcha)

    Verdure Sciences

    KLK OLEO
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • All Companies
      • Categories
      • Trade Associations
      • Company Capabilities
    • Nutraceuticals
      • Antioxidants
      • Dairy-Based Ingredients
      • Enzymes
      • Fatty Acids
      • Fiber & Carbohydrates
      • Green Foods
      • Herbs & Botanicals
      • Marine Nutraceuticals
      • Minerals
      • Omega 3s
      • Probiotics & Prebiotics
      • Proteins, Peptides, Amino Acids
      • Sweeteners
      • Vitamins
    • Markets
      • Consumer Trends
      • Contract Manufacturing
      • Cosmeceuticals / Nutricosmetics
      • Delivery & Dosage Technologies
      • Dietary Supplements
      • Flavors & Colors
      • Functional Foods & Beverages
      • Healthcare Trends
      • Medical Nutrition
      • Mergers & Acquisitions
      • Natural/Organic
      • Nutrition Bars
      • Packaging
      • Pet Nutraceuticals
      • Quality & Safety
      • Regulations
      • Research
      • Testing
      • World Markets
    • Health
      • Bone & Joint Health
      • Cancer Risk
      • Cardiovascular Health
      • Cognitive Function
      • Diabetes & Blood Sugar Management
      • Digestive Health
      • Energy
      • Eye Health
      • Healthy Aging
      • Immune Function
      • Infant & Children's Health
      • Inflammation
      • Men's Health
      • Mood Health & Sleep
      • Oral Health
      • Sexual & Reproductive Health
      • Skin Health
      • Sports Nutrition
      • Weight Management/Weight Loss
      • Women's Health
    • Online Exclusives
    • Webinars
    • Slideshows
    • Blogs & Guest Articles
    • Health E-Insights
    • Videos
    • Podcasts
    • Infographics
    • eBook
    • Whitepapers
    • Research
      • TrendSense
      • Monograph Center
      • White Papers
      • Research News
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Supplier Showcases
      • Companies
      • Product Releases
      • News Releases
      • Literature / Brochures
      • White Papers
      • Jobs
      • VIdeos
      • Services
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Columns

    Understanding The GRAS Self-Determination Process

    Gaining GRAS status can help companies expand their business into the fortified foods market.

    Understanding The GRAS  Self-Determination Process
    Related CONTENT
    • Unfolding the Interrelationship Between GI Health & Immunity
    • Transforming Health with Nature’s Sunshine
    • Understanding FTC Standards for Claims Substantiation
    • TREHA Trehalose Available As ‘Natural Flavor’
    • ConsumerLab.com Tests Popular Vitamin D Supplements
    Greg Stephens & Sandy Bigelow, Windrose Partners06.01.16
    Manufacturers of nutritional ingredients are legally allowed to market their product if they meet one of three criteria:
    1. The ingredient was lawfully marketed as a dietary supplement prior to Oct. 25, 1994 (which corresponds to the passage of the Dietary Supplement Health and Education Act, DSHEA);
    2. If the ingredient was introduced into interstate commerce on or after Oct. 25, 1994, then companies must submit a “new dietary ingredient” notification to FDA; or
    3. The manufacturer conducts an analysis demonstrating that the use of these ingredients in food and supplement products is Generally Recognized As Safe (GRAS). 
    The first two of these options, however, limit the ingredient use to dietary supplement applications only. For the manufacturer of food products (including medical foods) the ingredient must meet FDA’s GRAS standards.

    There are two approaches to achieve GRAS status, based on 1) history of safe use and 2) scientific procedures, or both, which are discussed in more detail here. Supplement ingredient companies can voluntarily notify the FDA regarding their GRAS self-determination, and FDA’s acknowledgement of this analysis enables greater acceptance from customers.

    Most supplement manufacturers and their suppliers have not taken advantage of the GRAS self-determination process, often because of the added cost to product development and their level of understanding of the process. Yet nowadays, some supplement companies on the vanguard are conducting GRAS self-determinations justified by the large potential that their dietary ingredients represent in the market beyond supplements—the total U.S. food supply. 

    Several advocates have recently called for greater transparency in the GRAS self-determination process to illuminate any potential for perceived conflict of interest, hoping to pressure the federal government to monopolize the GRAS process. The FDA has stated that by August 2016 it will finalize its 1997 proposal for the GRAS notification process as part of a legal settlement with the Center for Food Safety. It is expected that, among other issues, FDA will address the transparency and conflict of interest issues.

    The GRAS self-determination process has been used for food ingredients for more than 50 years, yet this process has not been widely used for supplement ingredients because of cost constraints and a full understanding of the process by the supplement manufacturing community. What follows is a business perspective overview of the process and the specific requirements to determine GRAS status for supplement ingredient use. 

    Qualified Experts
    Since 1958, manufacturers have been allowed to self-determine the GRAS status for specific use(s) of their ingredient(s) used in food products (62 FR 18,937 at 18,940). General recognition of safety may be based on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly added to food (21 CFR 170). 

    Manufacturers often hire an expert consultant external to their firm to prepare a GRAS dossier for the ingredient. The consultant convenes a panel of experts to address the issues identified during dossier preparation. The experts serve on the panel to determine whether the use of the ingredient is indeed GRAS, and to determine whether sufficient technical and scientific information exists as elaborated in the dossier to achieve general recognition that use of the ingredient is GRAS. 

    The panel convenes at a neutral site, deliberates pertinent issues, resolves them, and based on reasoned judgment, concludes whether the specific use(s) of the ingredient is GRAS. The panel develops and signs a consensus statement of its conclusions that embodies the issues raised during the panel review; this statement forms the basis of the GRAS self-determination. Both the dossier and statement of conclusions can be used by manufacturers to aid in the technical sales aspect of ingredient marketing. 

    Before each expert is selected, it must be established that he/she is free of conflict (actual or perceived)—be it financial, personal or professional—for or against the manufacturer or its competitors. These potential conflict(s) can be elaborated in the consensus statement to enable transparency of the safety determination.

    Experts can develop bias based on their experience(s). Bias is allowed if it is strictly based on scientific issues alone, as it is understood that expertise cannot be gained without developing some sort of intuitive bias and inclination on scientific issues. The expert panel should represent, as a whole, a balance of bias regarding the full gamut of issues related to the GRAS determination, and is composed in a manner that minimizes the likelihood of predilections and skewed judgment. Accordingly, subjective variability of the panelists, such as personal leanings not based on scientific data or “going with the conventional wisdom,” should be avoided. These steps are necessary to obtain a panel of experts that can objectively self-determine GRAS status independent of the manufacturer and other interested parties. 

    Safety Standards
    The safety standard component requires that for the use of a substance to be determined as GRAS, competent scientists must establish reasonable certainty that the substance is not harmful under its intended conditions of use (21 CFR 170.3(i); 62 FR 18,937 at 18,940). This has served well as an acceptable, time-tested standard for determining the safety of ingredients when consumed as part of the diet.

    A supplement and its ingredients are considered safe if they do not present a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling (21 CFR 190.6). Even though these safety standards differ slightly, on a practical basis, the GRAS self-determination process has been used for validating the safety and regulatory acceptability for both food and supplement ingredients. 

    FDA has listed the types of ingredients that are eligible for a GRAS self-determination (21 CFR 170.30), many of which are already used as supplement ingredients. Substances of biological origin consumed for their nutrient properties, without known detrimental effect, whether altered through breeding practices or otherwise, are eligible to be classified as GRAS. In addition, the use of substances of natural biological origin intended for consumption for other than their nutrient properties are also eligible for GRAS determination. 

    The agency recognizes two approaches that manufacturers can use to self-determine GRAS status for ingredient use: 1) “scientific procedures” and/or 2) in the case of a substance used in food prior to Jan. 1, 1958, through experience based on “common use” in food, which serves as the basis of expert opinion. 

    For the latter, general recognition of safety may be determined without the quantity or quality of scientific procedures required for approval of a food additive regulation. An ingredient not in common use in food prior to Jan. 1, 1958, may achieve general recognition of safety only through scientific procedures.

    General recognition of safety based upon scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of a food additive. For the scientific procedures approach, animal toxicology studies are often conducted with the substance. General recognition of safety through scientific procedures shall ordinarily be based upon published studies, which may be corroborated by unpublished studies and other data and information. 

    Primarily, the evidence for a GRAS determination must be publicly available in an effort to achieve and support general recognition by the scientific community. In defining consensus of the scientific community, the FDA recognizes that consensus does not require unanimity among qualified experts to satisfy the common knowledge element of the GRAS standard (62 FR 18,937). 

    In summary, since before DSHEA, supplement manufacturers have been enabled to GRAS self-determine the use of their supplement ingredients. This year the FDA is expected to finalize its 1997 proposal for the process of conducting GRAS self-determinations and submitting voluntary notifications, due in late 2016. 

    Understanding the considerations and requirements for conducting the GRAS self-determination process should help ingredient manufacturers make wise decisions. The outcome of GRAS self-determinations can help ingredient companies expand their markets to fortified/functional foods and medical foods. Most often the most effective and efficient approach to GRAS self-determination is to speak with a qualified consultant or firm to provide a preliminary GRAS opinion and, with your input, to lead the process forward. 

    References
    1. Code of Federal Regulations (CFR). U.S. Government Printing Office, Washington, D.C. 
    2. FCC 2014. Food Chemicals Codex, Ninth Edition. The U.S. Pharmacopeial Convention, Rockville, MD. 
    3. FDA 2007. FDA Redbook. Guidance for Industry and Other Stakeholders. Toxicological Principles for the Safety Assessment of Food Ingredients. pp. 286.
    4. Federal Register (FR). U.S. Government Printing Office, Washington, D.C.

    Gregory Stephens
    Windrose Partners

    Greg Stephens is president of Windrose Partners, a company serving clients in the the dietary supplement, functional food and natural product industries. Formerly vice president of strategic consulting with the Natural Marketing Institute (NMI) and vice president of sales and marketing for Nurture, Inc (OatVantage), he has 25 years of specialized expertise in the nutritional and pharmaceutical industries. His prior experience includes a progressive series of senior management positions with Abbott Nutrition (Ross Products Division of Abbott Laboratories). He can be reached at 267-432-2696; E-mail: gregstephens@windrosepartners.com.

    Sandy Bigelow

    Sandy Bigelow, PhD, DABT, is principal at Vanguard Global Associates LLC (VGA), a leading-edge consultancy of experienced associates who work together to develop creative solutions to their clients’ challenges. VGA helps clients deal with the safety and claims aspects of commercializing their ingredients and products. Mr. Bigelow is Board Certified in General Toxicology (DABT), qualifying a practice in safety assurance and evaluation.  
    Related Searches
    • DSHEA
    • Fortified
    • Natural
    • Regulatory
    Related Knowledge Center
    • Regulations
    • Quality & Safety
    • Functional Foods & Beverages
    Suggested For You
    Unfolding the Interrelationship Between GI Health & Immunity Unfolding the Interrelationship Between GI Health & Immunity
    Understanding FTC Standards for Claims Substantiation Understanding FTC Standards for Claims Substantiation
    Transforming Health with Nature’s Sunshine Transforming Health with Nature’s Sunshine
    TREHA Trehalose Available As ‘Natural Flavor’ TREHA Trehalose Available As ‘Natural Flavor’
    ConsumerLab.com Tests Popular Vitamin D Supplements ConsumerLab.com Tests Popular Vitamin D Supplements
    Gottlieb Confirmed to Lead FDA Gottlieb Confirmed to Lead FDA
    Study Links Lutein to Brain Health and Intelligence in Older Adults Study Links Lutein to Brain Health and Intelligence in Older Adults
    Cyber-Security Questions for Nutraceutical Company Executives Cyber-Security Questions for Nutraceutical Company Executives
    Study Ties Nutrition to Brain Health and Intelligence in Older Adults Study Ties Nutrition to Brain Health and Intelligence in Older Adults
    Challenges for Nutritional  Products in Healthcare Facilities Challenges for Nutritional Products in Healthcare Facilities
    Medical Nutrition Market Enhanced by Rising Incidence of Disease Medical Nutrition Market Enhanced by Rising Incidence of Disease
    An Interview with Sandy Bigelow of Vanguard Global Associates An Interview with Sandy Bigelow of Vanguard Global Associates
    How To Get The Most Out Of Trade Shows & Conferences How To Get The Most Out Of Trade Shows & Conferences
    Nutrition for the Whole (Furry) Family Nutrition for the Whole (Furry) Family
    Food Chemicals Codex to Focus on Natural Colors & Flavors, Functional Ingredients Food Chemicals Codex to Focus on Natural Colors & Flavors, Functional Ingredients

    Related Columns

    • Consumer Trends | Digestive Health | Immune Function | Medical Nutrition
      Unfolding the Interrelationship Between GI Health & Immunity

      Unfolding the Interrelationship Between GI Health & Immunity

      Diet and nutritional status are vitally connected to the immune and gastrointestinal systems.
      By Gregory Stephens, Windrose Partners, & Sheila Campbell, PhD, RD 06.02.17

    • Dietary Supplements | Digestive Health | Healthcare Trends | Herbs & Botanicals | Quality & Safety | World Markets
      Transforming Health with Nature’s Sunshine

      Transforming Health with Nature’s Sunshine

      With a long history in the supplement market, Nature’s Sunshine remains committed to quality and innovation.
      By Sean Moloughney, Editor 06.02.17

    • Dietary Supplements | Regulations | Research
      Understanding FTC Standards for Claims Substantiation

      Understanding FTC Standards for Claims Substantiation

      Randomized clinical trials aren’t the only source of competent and reliable scientific evidence.
      By Todd Harrison, Venable 06.02.17


    • Breaking News | Flavors & Colors | Supplier News

      TREHA Trehalose Available As ‘Natural Flavor’

      With improved manufacturing process, TREHA trehalose is now produced from non-GM starch using non-GM enzymes.
      05.25.17

    • Breaking News | Industry & Market News | Testing | Vitamins

      ConsumerLab.com Tests Popular Vitamin D Supplements

      Review includes test results and quality comparisons for 44 products.
      05.22.17

    Loading, Please Wait..
    Trending
    • Pycnogenol Evidenced To Have Skin Benefits In Dermatology Study
    • Nature’s Way Acquires Personalized Nutrition Company Baze
    • Oregon Files Lawsuit Against GNC
    • Chemi Nutra Introduces PS And PA Phospholipids For Functional Beverages
    • Study Examines Vitamin K2 Content In Cheese
    Breaking News
    • Vitamin K2 May Ameliorate Polycystic Ovary Syndrome
    • Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    • Omega-3 Fatty Acids Linked to Reduced Episodes of Depression
    • Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    • ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • A Growing Herbal Products Market Still Faces Formidable Threats, Challenges
    • Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality
    • Nutrition and Flavor: Formulating for Modern Product Preferences
    • Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains
    • How Will the European Green Deal Impact Dietary Supplements?
    • What Do Consumers Know About the Gut Microbiome?
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome
    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression
    Coatings World

    Latest Breaking News From Coatings World

    Indorama Ventures Posts Record 2Q 2022 Results
    Advanced Polymer Coatings Strikes Series of New Tanker Deals
    Barentz Named Distributor for Pilot Chemical Segments in US and Canada
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Spartech Promotes Three Staff Members
    Elisabeth Lackner Named Chief Scientific Officer at Element Materials Technology
    Natech Plastics Purchases Three New Injection Molding Machines
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Novavax Submits EUA for Protein-based COVID-19 Vax Booster
    BeiGene, Ontada Enter Strategic Oncology Alliance
    AskBio Appoints Clinical Ops Executives
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Mary Kay Supports International Women's Forum's Latest Research
    Vegamour Launches in the UK
    Maelys Rolls Out to Ulta Beauty
    Happi

    Latest Breaking News From Happi

    Dr. Bronner’s Releases 2022 All-One! Report, ‘Leading with Heart’
    In-Cosmetics Asia Returns to Bangkok to Deliver Look at Market Trends and Ingredient Innovations
    Perfect Corp. AI Skin Analysis Beauty SaaS Brand Console Is HIPAA-Compliant
    Ink World

    Latest Breaking News From Ink World

    BASF Breaks Ground on Riverfront Park in East Newark
    Roland DG Corporation to Relocate HQ to Miyakoda, Japan
    Gallus Launches Gallus One, Its First Fully Digital Inkjet Label Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Color-Logic partners to feature metallics at autumn events
    New Era Converting Machinery heads to The Battery Show
    Cyngient, Imageworx partner at Labelexpo for security labeling innovation
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Babyganics Introduces Triple Dry Diapers
    Daio Paper Acquires Pet Care Products Manufacturer
    Honest Reports Increased Revenue
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FundamentalVR Raises $20 Million in Series B Funding
    Bioventus Achieves Strong Growth in Q2 2022
    Bone Void Fillers Market Growing at 6%
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    onsemi Celebrates Expansion of Silicon Carbide Production Facility in New Hampshire
    Applied Materials CTO Dr. Om Nalamasu Receives IEEE Frederik Philips Award
    Weekly Recap: ALTANA, Universal Display and Emerson Top This Week’s Stories

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login