Fadi M. Aramouni, Ph.D

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EXTENSION VALUE-ADDED PROGRAM
Fadi M. Aramouni, Ph.D Professor, Extension
Specialist Food Systems
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EXTENSION VALUE-ADDED

• About 1,200 requests annually
• e-mail, telephone, letters, extension agents
• Funded by K-State Research and Extension
• Grants from KDOC (50,000 in 2003), USDA
  (HACCP/Food Safety)

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EXTENSION VALUE-ADDED

• Provide technical assistance to food companies
• New product development
• Formulations, processing, packaging
• Labeling. Nutrition Facts panels
• HACCP, GMPs, Food Safety, Shelf-life testing
• Trouble shooting, problem solving
• Media

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EXTENSION VALUE-ADDED

• 2 components
• Educational
• Seminars, workshops, newsletter, training
• Service
• Analyses, labels, ingredients, technical support

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• Kansas Department of Commerce and Housing (KDOCH)
  survey of food companies in the state (n84)
• 78 of respondents rated the quality of our
  services as Exceptional
• 22 as Satisfactory
• 0 Average
• 0 Unsatisfactory

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Public Health Security and Bioterrorism
Preparedness and Response Act of 2002

• Overview Background The Law The Bioterrorism
  Act requires domestic and foreign facilities that
  manufacture, process, pack, or hold food for
  human or animal consumption in the United States
  to register with the FDA by December 12, 2003.

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Who must register?

• Owners, operators, or agents in charge of
  domestic or foreign facilities that
  manufacture/process, pack, or hold food for human
  or animal consumption in the United States are
  required to register the facility with the FDA

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Is there a registration fee?

• No registration fee is required.
• FDA is aware that various firms may be offering
  their services to assist domestic and/or foreign
  facilities to register with FDA. Please note that
  these firms are not affiliated with FDA, nor has
  the agency contracted with any firms to register
  facilities

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What facilities are exempted from registration?

• Exempt from registration are farms retail food
  establishments restaurants non-profit
  establishments that prepare food for, or serve
  food directly to, consumers fishing vessels not
  engaged in processing as defined in 21 CFR 123.3
  (k) and facilities regulated exclusively
  throughout the entire facility by the U.S.
  Department of Agriculture

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How long will this take?

• FDA estimates that it will take one or two hours
  of a manager's time to read and understand the
  regulations. Filling out a registration form
  would take a total of one hour -- 45 minutes of
  an administrative worker's time and 15 minutes of
  an owner, operator, or agent-in-charge's time to
  certify the registration before submitting the
  form to FDA

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Electronic Registration via the Internet

• Computer System Requirements
• Internet Access Internet access is widely
  available
• Web BrowserThe online registration system
  supports the following web browsers
• Microsoft Internet ExplorerVersions 5.5, 6.0
• Netscape NavigatorVersion 7.1
• OperaVersion 7.0
• Additional hints
• Clear Browser Cache

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What Information Is Required?

• Name, physical address, phone number of the
  facility
• Same information for the parent company, if the
  facility is a subsidiary
• All trade names the facility uses
• Food product categories (21 CFR 170.3)
• A statement certifying that the information
  submitted is true and accurate and submitter is
  authorized to register the facility

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Where should label statements be placed on
containers and packages
Place all required label statements on the front
label panel (the principal display panel or PDP )
Place certain specified label statements on the
principal display panel and other labeling on
the information panel
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What label statements must appear on the
principal display panel?

• Place the statement of identity, or name of the
  food, and the net quantity statement, or amount
  of product

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Which label panel is the information panel

• The information panel is the label panel
  immediately to the right of the PDP, as displayed
  to the consumer

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What is information panel labeling ?

• label statements that are generally required to
  be placed together, without any intervening
  material
• name and address of the manufacturer, packer or
  distributor, the ingredient list, and nutrition
  labeling

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What type size, prominence and conspicuousness is
required?

• Use letters that are at least one-sixteenth
  (1/16) inch in height based on the lower case
  letter "o".
• The letters must not be more than three times as
  high as they are wide

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What name and address must be listed on the
label?

• Name and address of the manufacturer, packer or
  distributor. Unless the name given is the actual
  manufacturer, it must be accompanied by a
  qualifying phrase which states the firm's
  relation to the product, e.g., "manufactured for"
  or "distributed by."

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• Street address if the firm name and address are
  not listed in a current city directory or
  telephone book
• City or town
• State (or country, if outside the United States)
  and
• ZIP code (or mailing code used in countries other
  than the United States).

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What is the ingredient list?

• Descending order of predominance means that the
  ingredients are listed in order of predominance
  by weight
• Always list the common or usual name for
  ingredients unless there is a regulation that
  provides for a different term. For instance, use
  the term "sugar" instead of the scientific name
  "sucrose

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Is it necessary to declare trace ingredients

• If a substance is an incidental additive and has
  no function or technical effect in the finished
  product, then it need not be declared on the
  label. An incidental additive is usually present
  because it is an ingredient of another
  ingredient. Sulfites are considered to be
  incidental only if present at less than 10 ppm.

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What ingredient listing is necessary for chemical
preservatives

• When an approved chemical preservative is added
  to a food, the ingredient list must include both
  the common or usual name of the preservative and
  the function of the preservative by including
  terms, such as "preservative,"

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How are spices, natural flavors or artificial
flavors declared in ingredient lists?

• These may be declared in ingredient lists by
  using either specific common or usual names or by
  using the declarations "spices," "flavor" or
  "natural flavor," or "artificial flavor."
• Spices, such as paprika, turmeric, saffron and
  others that are also colorings must be declared
  either by the term "spice and coloring" or by the
  actual (common or usual) names, such as
  "paprika."
• Vegetable powders must be declared by common or
  usual name, such as "celery powder."

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FDA AUTHORITY OVER COSMETICS

• FDA is only able to regulate cosmetics after
  products are released to the marketplace. Neither
  cosmetic products nor cosmetic ingredients are
  reviewed or approved by FDA before they are sold
  to the public.
• FDA cannot require companies to do safety testing
  of their cosmetic products before marketing. If,
  however, the safety of a cosmetic product has not
  been substantiated, the product's label must read
  
• "WARNING The safety of this product has not been
  determined."

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• FDA does not have the authority to require
  manufacturers to register their cosmetic
  establishments, file data on ingredients, or
  report cosmetic-related injuries. To keep abreast
  of such information, FDA maintains a voluntary
  data collection program. Cosmetic companies that
  wish to participate in the program forward data
  to FDA

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• FDA can inspect cosmetics manufacturing
  facilities, collect samples for examination, and
  take action through the Department of Justice to
  remove adulterated and misbranded cosmetics from
  the market. Domestic and foreign manufacturers
  must follow the same regulations.

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Warning Letters Address Claims Made for Topical
Skincare Preparations

• Warning Letters issued to Basic Research, LLC and
  University Medical Products USA, Inc. illustrate
  an important legal distinction, the difference
  between a cosmetic and a drug under the Federal
  Food, Drug, and Cosmetic Act (FDC Act). The
  Warning Letters cited numerous drug claims
  associated with topical skincare preparations,
  noted on both product labeling and Web sites.

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• Among the claims cited in the Warning Letter and
  Amended Warning Letter issued to Basic Research,
  LLC were wrinkle and stretch mark reduction,
  stimulation of collagen synthesis, transdermal
  fat emulsification, and increased testosterone.

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• Among the claims cited in the Warning Letter to
  University Medical Products USA, Inc. were
  increased collagen production strengthening
  collagen and elastin fibers cellulite reduction
  through cellular stimulation to release stored
  fat weight reduction through appetite
  suppression, increased metabolism, and fat
  burning and reduced water retention.

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• Such claims establish the products' intended use,
  namely, to affect the structure or function of
  the body, thus causing them to be drugs under
  Section 201(g) of the FDC Act. Because these
  drugs are not generally recognized by qualified
  experts as safe and effective when used as
  labeled, they are new drugs under the section
  201(p) of the FDC Act and require an approved
  New Drug Application for legal marketing. The
  Warning Letters charge these products as
  unapproved new drugs in violation of Section
  505(a) of the FDC Act.

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COSMETIC LABELING

• The PDP must state the name of the product,
  identify by descriptive name or illustration the
  nature or use of the product, and bear an
  accurate statement of the net quantity of
  contents of the cosmetic in the package in terms
  of weight, measure, numerical count, or a
  combination of numerical count and weight or
  measure

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• The name and place of business of the firm
  marketing the product must be stated on an
  information panel
• The address must state the street address, city,
  state, and zip code. If a firm is listed in a
  current city or telephone directory, the street
  address may be omitted.
• If the distributor is not the manufacturer or
  packer, this fact must be stated on the label by
  the qualifying phrase "Manufactured for ......"
  or "Distributed by ......"

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• The ingredients must be declared in descending
  order of predominance. Color additives and
  ingredients present at one percent or less may be
  declared without regard for predominance.
• The ingredients must be identified by the names
  established or adopted by regulation
• Those accepted by the FDA as exempt from public
  disclosure may be stated as "and other
  ingredients"

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Cruelty Free--Not Tested on Animals

• Some cosmetic companies promote their products
  with claims such as "CRUELTY-FREE" or "NOT TESTED
  ON ANIMALS" in their labeling or advertising.
• The unrestricted use of these phrases by cosmetic
  companies is possible because there are no legal
  definitions for these terms.

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• THANK YOU
• QUESTIONS????