From FCC e-Newsletter (Summer 2010)
United States Pharmacopeial Convention (USP) and the Food Chemicals Codex (FCC) at Institute of Food Technologists (IFT) 10th Annual Meeting and Food Expo, July 18–20, 2010 in Chicago
At the IFT 10th Annual 2010 Meeting and Food Expo, USP was represented on the exhibition floor at booth #3373 and hosted three symposia and presented four posters as described below.
Symposium: Compendial quality standards for food ingredients – an efficient first-line defense against economically motivated adulteration
(Session 105; Monday, July 19; 8:30–10:00 a.m., Room S501cd)
Compendial standards set acceptance criteria and describe test methods to define what a food ingredient is, rather than focusing on compounds that are not supposed to be present. Thus, compendial standards define the purity, identity, and quality – in short the authenticity – of food ingredients, and they can be used to tightly define any food ingredient in commerce. Recent incidences of food ingredients that have been adulterated for economic gain highlight the necessity of applying tighter standards to keep the food supply chain safe. Wherever economically motivated adulteration occurs, the safety of the adulterated product is determined exclusively by the ethics and knowledge of the adulterer, thus bypassing all other safety considerations by governmental organizations. The development and use of compendial standards can help to provide a first line of defense against the potential adulteration of food ingredients, especially newer standards that have been dev! eloped with a specific emphasis on detecting adulteration.
Symposium: Quality and safety of functional foods – from naturals to designer molecules, new challenges to keep the food supply chain safe
(Session 215; Tuesday, July 20, 8:30–10:00 a.m., Room S503ab)
More and more functional foods are incorporated into mainstream foods as consumers are appreciating their benefits. New frontiers are opened through the development of new sources and ultimately the design of molecules according to desired specifications. This session will highlight some of the latest innovations in the development of functional foods and discuss the challenges that long supply chains may have. The special product of today with well-controlled supply chains may transform into a common commodity of tomorrow. A quality standard defining the authenticity, identity, and purity of such an ingredient will be an essential tool to maintain its quality and ultimately its safety throughout such a transition.
Symposium: Dietary supplement safety assessment: past, present, and future
(Session 119; Monday, July 19; 10:30 a.m.–12:00 p.m., Room S501cd)
With the growth in dietary supplement use in many countries, there is an increasing need to assess the safety of such products; this is not an easy task. Both the quantity and quality of information with respect to toxicological and clinical effects are challenging. Adverse reactions are typically underreported, and the interpretation of reported cases is often difficult. Challenges also exist due to the complex nature of many dietary supplements. Many dietary supplements are obtained from raw/crude botanical or other natural (marine, mineral, etc.) sources; they are not singular, highly purified moieties. Further, many are presented to the public as complex mixtures incorporating an ever-increasing number of individual ingredients, such as herbs, vitamins, and minerals. In the U.S. under DSHEA, dietary supplements are assessed by the manufacturer/distributor and held to a lesser safety standard than food, i.e., the "reasonable expectation of no harm." This symposium will not only address some of the historical and continuing challenges faced when assessing dietary supplement safety, but will also highlight emerging initiatives and toxicological methods aimed at overcoming these challenges.
Poster: Opportunities to modernize the compendial quality standard for food-grade glycerin to reduce the risk of adulteration
(#142-14; Monday, July 19; 11:00 a.m.–1:30 p.m.)
[Moore, J.C.*; DeVries, J.W.**; Lipp, M.*; Holloway, G.*; Griffiths, J.C.*; * = U.S. Pharmacopeia Staff; ** = Medallion Labs/USP Food Ingredients Expert Committee]
Human consumption of adulterated glycerin includes many tragedies over the past century involving hundreds of deaths. In the United States, recent revisions to the compendial standard for excipient-grade glycerin have been implemented to reduce the risk for adulteration of medicines (both prescription and over-the-counter) with diethylene glycol (DEG) and ethylene glycol (EG). The objectives for this study were to characterize the risks of potential dietary exposure to DEG adulterated glycerin, to assess the likelihood of economic adulteration and supply chain issues, and to identify opportunities to modernize the Food Chemicals Codex (FCC) standard for glycerin to mitigate the risk for adulteration with DEG and other potential adulterants. Results indicate that economic incentive and supply chain confusion could lead to gross adulteration of food-grade glycerin, and that low-level adulteration from supply chain contamination is possible. Dietary exposure to DEG/EG adulterat! ed glycerin would pose a serious food safety concern even when adulterated at low levels. The current FCC standard for glycerin is capable of only detecting materials adulterated with significant (5–10%) levels of DEG, and flagrant replacement with other potential adulterants. To prevent the risk of low-level DEG/EG adulteration of glycerin, the addition of a GC method capable of detecting such adulterants is recommended for the FCC. Investigation into new quantitative assay methods capable of distinguishing glycerin from other potential economic adulterants is also recommended.
Poster: Current regulatory challenges surrounding "inactive ingredient (excipient)" use in dietary supplement applications
(#142-13: Monday, July 19; 11:00 a.m.–1:30 p.m.)
[Catherine Sheehan*; Ranga Velagaleti**; James Griffiths*; * = U.S. Pharmacopeia Staff; ** = BASF]
Excipients are by definition inert substances often used as a diluents or vehicles in dosage forms. They may have "functional" roles that can make a pharmaceutical and/or dietary supplement dosage form achieve a desired performance. The purpose or role (e.g., functionality) of a given excipient(s) in a dietary supplement dosage form (e.g., tablets, capsules) is similar to the traditional role of a given excipient(s) added to achieve the delivery and thus therapeutic effect of an active pharmaceutical ingredient in a final drug product. The performance requirements or critical material attributes (e.g., particle size, size distribution, surface area) of the selected excipient(s) ensures consistent performance throughout the product life-cycle, whether that product be a pharmaceutical or a dietary supplement. The similarity lies in ensuring the dosage form retains its targeted physical form, consistency, and palatability for human consumption, bioavailability, and adsorption/desorption of the active ingredient(s) within the human body. The history of excipients use in dietary supplements and current pharmacopeial and regulatory expectations for their continued use will be covered. The pre-DSHEA "grandfathered" excipients will be reviewed and their use in current dietary supplement manufacturing explained. FDA's Food Additive Status list provides a resource for those needing traditional dietary supplement excipients approved uses. For those potential excipients neither grandfathered through historical use nor appearing on the Food Additive Status list, approaches wi! ll be reviewed to determine their requirements for classification as Generally Recognized As Safe (GRAS) to enable them to be used in dietary supplement dosage forms, including potentially via FDA-approved drug products, and consequent listing in the FDA Inactive Ingredient (IIG) database.
Poster: Protein adulteration with non-declared potential allergenic proteins: can quality standards play a role?
(#142-26, Monday, July 19; 11:00 a.m.–1:30 p.m.)
[Moore, J.C.; Griffiths, J.C.; Lipp, M.]
Allergenic proteins are an important food safety issue, yet most of the routine testing for allergens occurs in finished food products. High-value, protein-based ingredients have historically been susceptible to economically motivated adulteration with alternative (cheaper) proteinaceous materials. The fraudulent substitution of presumed non-allergenic proteins with allergenic proteins could cause significant adverse public health consequences and/or lead to product recalls. Testing of protein-containing ingredients for authenticity/identity and purity early in the supply chain may be a potential option to reduce the risk of allergen safety issues and help prevent the need to recall finished products for the presence of undeclared allergens. Compendial quality standards can provide more selective analytical methods to better identify and distinguish authentic protein ingredients from those that may be contaminated with non-authentic, potentially allergenic proteins.
Poster: Limits for elemental contaminants in dietary supplements: compendial perspectives
(#142-21, Monday, July 19; 11:00 a.m.–1:30 p.m.)
[Tokiwa, Y.; Giancaspro, G.I.; Griffiths, J.C.; and Sarma, D.]
Elemental contamination in some dietary supplements is a well-recognized problem. The natural origin of some dietary supplement ingredients (such as herbals, or natural calcium) might contribute heavy metals, in some cases depending on the part of the plant used, the geographical location of cultivation, or the way they are processed. USP is an official public standards-setting authority for all prescription products and also sets widely recognized standards for food ingredients and dietary supplements. Recently, an informational General Chapter, <2232> Elemental Contaminants in Dietary Supplements, was developed, which proposes daily exposure limits for inorganic arsenic (15 μg/day), cadmium (5 μg/day ), lead (10 μg/day ), mercury (15 μg/day), and methyl mercury (2 μg/day). The proposed limits for elemental contamination in dietary supplements are derived by subtracting their average exposures from air, food, water, and prescription drugs, from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) provisional tolerable weekly intake (PTWI) levels. A safety factor ranging between 5% and 15% was used to calculate the suggested limits. Using this safety range, the resulting values are consistent with proposed Pharmeuropa limits and Health Canada and! WHO proposals. Dietary supplements, especially those of a botanical or marine raw material stock, may be contaminated with high levels of arsenic, cadmium, lead, mercury, and methyl mercury. Compendial monographs need to take these compounds into consideration when setting quality specifications.
USP's First-ever Nomenclature Workshop Addresses Food Ingredient Naming Challenges
What: Compendial nomenclature: overview and challenges
When: Monday–Tuesday, July 27–28, 2010
Where: USP Headquarters, Rockville, Maryland
Highlights of this first-ever Nomenclature Workshop include
In addition, participants will learn about the United States Adopted Names (USAN) Council, International Nonproprietary Names (INN), ISO, and other drug product naming initiatives. Participants also will be able to provide input on implementation and communication issues related to the USP Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations.