Food Law and Labeling News |
| Oct, 2008 |
Clarification of Chocolate Standards & Sweet Whey Powder
During the past week, we have received many inquiries from different companies both in the US and in Germany concerning the permissibility of Sweet Whey Powder in chocolate. After contacting the FDA, we were informed of the following:
"When we spoke yesterday you asked about the use of whey powder in the “Chocolate” product that is defined in 21 CFR 163.111. This standard of identity does not list whey powder as an optional ingredient in “chocolate.”
"In your e-mail you ask about the use of whey in milk chocolate. Milk chocolate falls under the standard of identity in 21 CFR 163.130 which provides for the use of the following dairy ingredients: cream, milkfat, butter, milk, concentrated milk, evaporated milk, sweetened condensed milk, dried milk, skim milk, concentrated skim milk, sweetened condensed skim milk and nonfat dry milk. Since whey powder is not one of the dairy ingredients that is listed the standard of identity for milk chocolate, it can not be used in the formulation of a product that is intended for the US market.
"In summary, the US standards for chocolate products do not provide for the use of whey powder."
-- Statement by the FDA
The links to the above-mentioned Code of Federal Regulations are provided below.
Chocolate Standards Regulations
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| Oct, 2008 |
Whey Powder in Baked Goods - Allergen Advisory
It has come to our attention that "whey powder" and "sweet whey powder" are being used as ingredients in cookies, cakes and other baked goods.
Please be advised that although in Europe it is "understood" that this ingredient stems from milk and is, therefore, an allergen, that is NOT the case in the US.
As a result, the FDA requires the allergen regulations to be followed. There are 2 options for the declaration of this ingredient:
1. As part of the ingredient statement: ".....sweet whey powder (milk)"
OR
2. As part of the "Contains......"-Statement, which lists all allergens contained in the product. This declaration appears immediately after the ingredients list.
If you have any additional questions concerning this topic, please do not hesitate to contact us.
Whey Powder in Baked Goods - Allergen Advisory
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| Oct, 2008 |
Germany Takes Action on Melamine-Tainted Chocolate from China
The Deutsche Welle reported on October 1, 2008 that A German state consumer protection ministry says Chinese candies tainted with the industrial chemical melamine have been found for sale in an Asian foods store in the southern state of Baden Wuerttemberg.
A ministry spokesman in the southern German state of Baden Wuerttemberg confirmed on Wednesday, Oct 1 that Chinese-made "White Rabbit" candies, imported through the Netherlands, were tainted with melamine in an escalating toxic milk scandal that has sickened more than 50,000 and killed four babies in China and sparked alarm in a host of countries.
Both the Chinese producer and the Dutch importer have begun recalling the products, the spokesman said, adding there was no concrete health danger.
German and European Ministries remain vigilant to keep consumers at home and abroad safe from these tainted Chinese products.
Deutsche Welle Report
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| Oct, 2008 |
FDA Issues Interim Risk & Safety Assessment on Melamine
The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.
A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods.
The safety/risk assessment, prompted by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China, was conducted by scientists from FDA's Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The FDA reviewed scientific literature on melamine toxicity. The FDA is in the process of identifying a group of experts that would be charged with the task of reviewing the risk assessment and providing guidance regarding the current gaps in scientific knowledge relating to the toxicity of melamine and its analogues.
FDA Interim Safety & Risk Assessment
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| Sep, 2008 |
USDA Permits Required for Some Dehydrated Soups
Dehydrated soups that contain eggs, egg products, milk and/or milk products MUST obtain an import permit before shipping to the US. This also applies to breaded seafood and breaded crab cakes.
APHIS has requested a science-based risk analysis to determine whether such permits are still necessary. If a powdered soup's ingredients are fully cooked, APHIS would require a foreign government certificate stating that. Most dehydrated soups also contain beef or chicken extract, which adds to the Agency's cautiousness. They are, however, looking at changing the present regulation should the risk assessment analysis prove the current requirements to be unnecessary.
An explanation of affected products that require an import permit appears in the APHIS Animal Product Manual (APM).
Fully cooked and processed products such as confectionery, baked goods, breads, etc. are NOT included in these regulations. They continue to fall totally under the jurisdiction of the FDA.
Animal Product Manual
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| Jul, 2008 |
FDA "Third Party Certification Programs for Foods & Feeds"
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Voluntary Third-
Party Certification Programs for Foods
and Feeds.’’ This draft guidance
describes the general attributes FDA
believes a voluntary third-party
certification program should have in
order to help ensure its certification is
a reliable reflection that the foods and
feeds from certified establishments are
safe and meet applicable FDA
requirements.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by September 8, 2008
July 10, 2008 Federal Register Notice
Draft Guidance |
| Jul, 2008 |
Canada Issues Food Allergen Labeling Proposal
Health Canada published its Proposed Amendments to the Food Allergen Labelling Regulations in Canada Gazette, Part I (CGI) on July 26, 2008 to allow for public comment. Health Canada will take into consideration any comments received during the 90-day comment period before bringing the final regulations forward and publishing them in the Canada Gazette, Part II.
At the same time, Health Canada also issued updated guidance to industry, urging food manufacturers to enhance labelling of priority allergens, gluten sources and added sulphites in prepackaged foods.
Food Allergen Labeling Proposal
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| May, 2008 |
TTB Announces Consumer Corner Website
The Alcohol and Tobacco Tax and Trade Bureau (TTB) has announced the availablity of a Consumer Corner Website. It provides information on the agency and its responsibilities as well as issues that are or may be of interest to consumers.
Consumer Corner Website
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| May, 2008 |
TTB Implements Certification Requirements for Imported Natural Wine
The Alcohol and Tobacco Tax
and Trade Bureau (TTB)is adopting as a final
rule, without changes, the temporary
regulations implementing the
certification requirements regarding
production practices and procedures for
imported natural wine. These
requirements were adopted in section
2002 of the Miscellaneous Trade and
Technical Corrections Act of 2004 as an
amendment to section 5382 of the
Internal Revenue Code of 1986.
Effective Date: This final rule is
effective on May 28, 2008.
FOR FURTHER INFORMATION CONTACT:
Jennifer Berry, Alcohol and Tobacco
Tax and Trade Bureau, Regulations and
Rulings Division, P.O. Box 18152,
Roanoke, VA 24014; telephone 540–
344–9333.
April 28, 2008 Federal Register Final Rule
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| May, 2008 |
TTB Issues Guidance for Imported Wine Certification
Imported natural wine produced after December 31, 2004, must have the required certification. TTB is providing guidance and a convenient format for the certification.
There is also a useful Question-and-Answer Section
Certification Requirements for Imported Wine
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| May, 2008 |
Canada Issues Food and Consumer Safety Action Plan
Canada's food supply is increasingly global in nature and many Canadians are seeking clearer information about the foods they buy. Recognizing this, the Government of Canada is taking action to improve the labelling information on food products and to help Canadians make better purchasing decisions.
Following the launch of the Healthy Canadians website on October 24th, 2007, Prime Minister Stephen Harper announced Canada's Food and Consumer Safety Action Plan on December 17th, 2007, with the goal of ensuring Canada's product safety standards are second to none.
As part of the Food and Consumer Safety Action Plan, the Government committed to reviewing the policy on the use of "Product of Canada" and "Made in Canada" claims on food labels and advertising.
Food and Consumer Safety Action Plan
Healthy Canadians Website |
| Apr, 2008 |
FDA Launches Guide to Help Consumers Make Healthier Choices
The FDA has published a brochure that is intended to assist consumers in making healthier food choices by teaching them how to read the food label. The focus is on the Nutrition Facts Panel, but label claims are also explained. The agency is also urging consumers to request nutrition information in full-service and fast- food restaurants. There are useful links if a consumer needs or wants more detailed information.
FDA Consumer Food Label Brochure
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| Apr, 2008 |
Food Labeling Guide Update
The FDA has finally updated the "Guidance for Food Industry -- Food Labeling Guide." It is the first revision in many years. The Guide is presented in a question-and-answer format with examples of label formats, charts explaining rounding rules and detailed explanations of various claims. It is a useful, easy-to-understand resource guide. The 102-page document is also available in a printable format.
Food Labeling Guide
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| Apr, 2008 |
FDA Updates Bioterrorism Compliance Rates
In a recent notice, FDA announced the compliance rates of domestic and foreign facilities and what possible action is being considered for companies who continue to refuse to comply. To date, more foreign facilities than domestic have met the registration requirements. Of the 198,271 foreign companies registered, 3,668 are in Germany. US companies total 142,159. The FDA anticipates 420,000 registrations in total, however, only 340,430 have done so.
FDA Food Facility Registration Compliance Report
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| Apr, 2008 |
FSIS Announces Changes to Omaha Tech Center
The Food Safety & Inspection Service (FSIS) has announced recent changes in the Office of Policy and Program Development (OPPD). They are also informing industry and trade how they can contact the Policy Development Division (PDD), formerly known as the Technical Service Center,located in Omaha, more effectively.
The agency has simplified and provided detailed information for contacting the correct department with a particular question or problem.
FSIS Notice 26-08 - Contacting PDD (Formerly Technical Service Center)
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| Apr, 2008 |
Food Protection Plan Outreach Activities
The Food and Drug Administration (FDA) is announcing that it
is establishing a public docket to receive information and comments
related to its comprehensive Food Protection Plan (the Plan) released
in November 2007. The new Plan presents a robust strategy to protect
the nation's food supply from both unintentional contamination and
deliberate attack. FDA is establishing this docket for the purpose of
soliciting comments from its stakeholders on the Plan and the questions
set forth in this notice.
Submit written or electronic comments by July 31, 2008.
Federal Register Announcement
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| Apr, 2008 |
FDA Announces Plan for Third Party Certification Programs for Foods
The Food and Drug Administration (FDA) is requesting comments
on the use of third-party certification programs for foods and feeds,
including pet foods. An increasing number of firms that sell foods to
the public, such as retailers and food service providers, are
requesting that their suppliers become certified as meeting food (and
feed) safety and quality standards as a condition of doing business.
FDA seeks more information on the existence and use of these types of
programs to better understand how they can help to ensure that food
products are safe, secure, and meet FDA requirements.
Comments must be submitted by May 19, 2008
Federal Register Announcement
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| Feb, 2008 |
FDA Plans to Post Inspectors Overseas
The January 25, 2008 New York Times On the Web reported that FDA Commissioner Dr. Andrew von Eschenbach intends to post inspectors in embassies and consulates throughout the developing world in hopes of improving the quality of food and medicines increasingly flowing to the United States.
Details are still unclear as to how this program will be funded or when it will be implemented. The plans are still in their infancy. Regions envisioned for staffing include: India, China, Europe, Middle East, Central and South America.
Dr. von Eschenbach still needs to work out with the State Department how inspectors might interact with other parts of the federal government. In addition, host nations would have to request their presence, he said.
FDA Plans to Post Inspectors Overseas
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| Feb, 2008 |
Possible New Nutrition Reference Values and Declarations
The Food and Drug
Administration (FDA) issued an
advance notice of proposed rulemaking
(ANPRM) to request comment on what
new reference values the agency should
use to calculate the percent daily value
(DV) in the Nutrition Facts and
Supplement Facts labels and what
factors the agency should consider in
establishing such new reference values.
In addition, FDA requests comments on
whether it should require that certain
nutrients be added or removed from the
Nutrition Facts and Supplement Facts
labels. Comments on what factors
should be considered to update the
agency’s reference values will inform
any FDA rulemaking that may result
from this ANPRM.
DATES: Submit written or electronic
comments by January 31, 2008.
ADDRESSES: You may submit comments,
identified by Docket No. 2006N–0168,
by any of the following methods:
Electronic Submissions
Federal Register ANPRM Notice
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| Feb, 2008 |
FDA Comment Extension for Nutrition Labeling Reference Values
The Food and Drug
Administration (FDA) is extending to
April 30, 2008, the comment period for
the advance notice of proposed
rulemaking (ANPRM) that appeared in
the Federal Register of November 2,
2007 (72 FR 62149). In the ANPRM,
FDA requested comments on what new
reference values the agency should use
to calculate the percent daily value (DV)
in the Nutrition Facts and Supplement
Facts labels and what factors the agency
should consider in establishing such
new reference values. In addition, FDA
requested comments on whether it
should require that certain nutrients be
added or removed from the Nutrition
Facts and Supplement Facts labels. The
agency is taking this action in response
to requests for an extension to allow
interested persons additional time to
submit comments.
Federal Register Comment Extension Notice
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