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Expert in Regulatory Requirements for Food Additives, Color Additives and GRAS Substances
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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While some sugars and sugar alcohols maybe produce synthetically (at least in part), the term artificial sweetener is ordinarily applied to the intensely sweet synthethic additives: aspartame, acesulfame potassium, sucralose. saccharin, and neotame. Expert supervised the drafting of FDA approval documents for aspartame, acesulfame and sucralose as well as responses to objections to the first two. He was heavily involved in the neotame approval also and is very familiar with the regulatory aspects of saccharin. He spoke often to the press on such issues during his nearly 29 years at FDA.
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The term "food additive" has a special legal definition and includes ingredients, food contact materials that may migrate to food, and radiation equipment used to treat food. The signicance of the definition is that anything meeting the definition must be approved by regulation before using it with food. It is to be contrasted with those substances whose use is generally recognized as safe by qualified experts (GRAS). substances whose use is GRAS are excepted from the food additive approval requirements. He drafted or supervised drafting of numerous food additive regulations.
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Food additive regulations must be promulgated by FDA before a food additive may be used with food. Such regulations identify the additive and prescibe how it may be used. Food containing additives not authorized for such use is deemed adulterated as a matter of law and can be seized and destroyed. Expert has experience with the regulations surrounding food additives.
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Expert can help to determine if a food additive is safe. Food additives must be shown to be safe under their intended conditions of use before use is legal. Safety assessment requires a clear chemical identity, possibly with specifications, an estimate of how much is likely to be consumed by those who commonly choose foods where it is used, and animal feeding studies showing lack of harm to animals consuming prportionately far more than humans would. Typically, lifetime feeding studies and reproduction studies will be conducted in two rodent species with noo adverse effect when consumed at 100 times human exposure. Specialized knowledge may modify such requirements.
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21 CFR 175 lists several ingredients that may be used as coatings on metal. Its original and main purpose is for coatings on the inside of food cans. Because such use condtions are very severe, the coatings may also be used on permanent equipment not made of metal. The regulations provide end tests to ensure proper application. Part 175 also lists adhesives used behid a functional barrier except for some contact at the seams. Other, more minor, descritions of coating material also are covered. Expert understands 21 CFR 175 inside and out and can help you to ensure that your product meets its requirements.
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Because food packaging materials that contact food may migrate in small amounts into food, they must be approved before their use is permitted. Approval applies to components of packaging but the final formulation does not require approval if all components comply with regulation. Historically, approval has come about by formal regulation, with special "threshold of regulation" exemptions issued by letter for trivial applications (21 CFR 170.39). Since 1999, most approvals have come about by a notification process established by statute and apply only to the notifier. He can help to work through food packaging regulations.
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Color Additives come under their own statutory provisions and must be safe and suitable for use. Unlike food additives, there are no exceptions to the approval process (such as for GRAS ingredients). Color additives may be derived from nature or be synthetic peroleum-based products. Synthetic color additives generally require certification for purity (since 1938) because the possibility of highly toxic impurities is a concern). Colpr additive petitions require payment of a fee for review and certification for purity by FDA chemists also is fee-based. Certified color additves bear rhe names FD&C Color # x. Expert can help you navigate the approval process for food color additives.
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Expert knows that substances whose use is generally recognized as safe (GRAS) by qualified experts do not require premarket approval by FDA. Based on the definition of a food additive, the various food ingredients in a stew recipe (and even water) would all require safety evaluation and approval if not for the GRAS exception. The safety of substances may be GRAS based on a demonstration of safety by common use prior to 1958 or by widely known (generally published) information. Criteria for GRAS are described in 21 CFR 170.30.
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The term indirect additive has been applied to substances that are not intended to be ingredients in food but become components in food indirectly by how they are used. Usually this applies to food packaging materials or processing equipment in direct contact with food but may apply also to other substances used in a manner such that their presence of food is expected though not desired. The term has no special legal meaning although it has been a useful as a way of describing substances requiring safety evaluation and approval but not ingredient labeling.
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Food sweeteners may be synthetic or natural, providing little or no calories because their intensity requires very small amounts or providing calories typical of other carbohydrates. Intense sweeteners do not affect other technical functions, such as viscosity or mouth feel, as do the sugars and sugar alcohols. Some sweeteners (e.g., sugar alcohols) are not readily absorbed or digested and can cause gastrointestinal disturbances if consume in very high amounts. All food sweeteners must meet the same safety standard. He has experience with many food additives both natural and synthetic.
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Nonnutritive sweeteners are generally very intense, providing sweetness at very low levels of use. They may be nonnutitive because they are not metabolized or because the levels are too low to be nutritionally significant. In the U.S. we think of acesulfame potassium, aspartamr, neotame, saccharin, and sucralose as nonnutitive. Aspatame as been described as nutritive because it supplies two amino acids and some calories although the levels are too low to be significant. He has many years of experience with nonnutritive sweetners.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Baltimore, Maryland;
Frederick, Maryland;
Gaithersburg, Maryland;
Bowie, Maryland;
Richmond, Virginia;
Alexandria, Virginia;
Wilmington, Delaware;
and Lancaster, Pennsylvania.
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Degree |
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Subject |
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Institution |
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1968
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PhD
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Physical Chemistry
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Indiana University
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1961
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BS in Chemistry
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Chemistry
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U of Michigan
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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1977 to 2006
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Food & Drug Administration
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Office of Food Additive Safety
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Associate Director for Science and Policy
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Directed Scientific Staff in safety review and document preparation for food ingredients, food contact materials, food irradiation, and biotechnology.
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1976 to 1977
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Lehigh University
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Emulsion Polymer Institute
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Research Associate
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Conducted research on emulsion polymers and provided mentoring support to graduate students.
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1967 to 1976
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Lafayette College
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Chemistry Department
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Assistant Professor
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Taught chemistry and served two years as long-range planning coordinator.
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Associations/Societies
American Chemical Society
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| Publications: |
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Selected Publications and Publishers
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- Journal of Food Protection
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- Radiation and Public Perception
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- Food Safety Assessment
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- Food Control
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- The Analysis, Communication and Perception of Risk
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| Government Experience: |
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| Years |
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Agency |
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Role |
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Description |
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1977 to 2006
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Food & Drug Administration
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Regulatory Scientist
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He managed the safety review of food & color additives, drafted Federal Register decision documents and supervised such activity
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Recent Litigation Client Requests:
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Expert for consulting on interpretation and explanation of "fields of use" in license agreement.
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Expert in mineral oil product for consulting on determining whether substance is GRAS for use in particular application in food.
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| International Experience: |
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Country / Region |
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Summary |
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1992 to 1992
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Switzerland
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He served on expert panel on food irradiation for World Health Organization.
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| Additional Skills and Services: |
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Training/Seminars
He taught college level chemistry for several years and has given numerous presentations on food additive safety at professional meetings.
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Education
