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Probiotics: Safety Issues


Probiotics: Safety Issues Francis B Palumbo, PhD, Esq. University of Maryland School of Pharmacy Center on Drugs & Public Policy * * * Section 406 . – PowerPoint PPT presentation

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Title: Probiotics: Safety Issues

Probiotics Safety Issues
  • Francis B Palumbo, PhD, Esq.
  • University of Maryland
  • School of Pharmacy
  • Center on Drugs Public Policy

  • Must be safe and effective
  • Effectiveness demonstrated by substantial
    evidence (i.e. well controlled clinical trials)
  • Safety data compiled throughout the clinical
    trials process.

  • Post market safety data collected via Medwatch
    and entered into FDAs AERS.
  • Safety continually evaluated.

Conventional Foods
  • Ordinarily injurious to health standard
  • Standard for adulteration of food caused by
    naturally occurring substances.
  • Less rigorous safety standard than for added

Food Shall be Deemed to be Adulterated
  • If it bears or contains any poisonous or
    deleterious substance which may render it
    injurious to health, but if not an added
    substance it will not be adulterated if the
    quantity of substance does not ordinarily render
    it injurious to health.

Food Shall be Deemed to be Adulterated
  • If it bears or contains
  • any added poisonous or deleterious substance that
    is unsafe within the meaning of section 406 FDCA
    (tolerances for poisonous ingredients).
  • Pesticide residue
  • Unsafe food additive or unsafe new animal drug

Food Shall be Deemed to be Adulterated
  • Consists in whole or part of any filthy, putrid,
    or decomposed substances, or if it is otherwise
    unfit for food.
  • Prepared, packed or held under unsanitary
  • Others

GMPs Foods?
  • The food industry, however, does observe the
    concept of GMPs and FDA has promulgated several
    regulations establishing current GMPs in the
    manufacturing, packing, or holding of human food
    (21 C.F.R. 110)

Enforcement Actions GMPs
  • In enforcement actions, FDA usually does not rely
    on the food GMP regulations as creating legally
    binding requirements against the food industry
  • Instead, FDA uses evidence gathered during
    factory inspections to prove a direct violation
    of the Food Drug Cosmetic Act.

Dietary Supplements
  • Under DSHEA, manufacturer is responsible for
    ensuring that the DS is safe before it is
  • FDA can take action if product is adulterated or

Dietary Supplement Adulteration
  • The dietary supplement failed the general food
    safety standard in that the product bears any
    poisonous or deleterious substance which may
    render it injurious to health.
  • if it presents a significant or unreasonable risk
    of illness or injury under conditions of use
    recommended or suggested in the labeling or,
    under ordinary conditions of use if no conditions
    of use are suggested or recommended in the

Dietary Supplement Adulteration
  • if it is a new dietary ingredient for which there
    is inadequate information to provide reasonable
    assurance that such ingredient does not present a
    significant or unreasonable risk of illness or

Dietary Supplement Adulteration
  • if the Secretary (of HHS) declares it to pose an
    imminent hazard to public health
  • if it contains a food additive (not a dietary
    ingredient) that is unapproved for such use, is
    not generally recognized as safe or is otherwise

Dietary Supplement Adulteration
  • if it failed to meet current good manufacturing
  • Dietary supplement manufacturers follow the
    general food GMPs

Food Additives
  • A manufacturer wishing to market a new ingredient
    in a conventional food can
  • Make a self determination of GRAS
  • File a notification with FDA asking that they not
    object to the self determination, or
  • File a food additive petition supported by
    extensive toxicology testing

Generally Recognized as Safe (GRAS)
  • Any substance that is intentionally added to food
    is a food additive and is subject to premarket
    review and approval by FDA, unless the substance
    is generally recognized, among qualified experts,
    as having been adequately shown to be safe under
    the conditions of its intended use, or unless the
    use of the substance is otherwise excluded from
    the definition of a food additive.

  • the use of a food substance may be GRAS either
    through scientific procedures or, for a substance
    used in food before 1958, through experience
    based on common use in food.

  • Under 21 CFR 170.30(b), general recognition of
    safety through scientific procedures requires the
    same quantity and quality of scientific evidence
    as is required to obtain approval of the
    substance as a food additive and ordinarily is
    based upon published studies, which may be
    corroborated by unpublished studies and other
    data and information.
  • Under 21 CFR 170.30(c) and 170.3(f), general
    recognition of safety through experience based on
    common use in foods requires a substantial
    history of consumption for food use by a
    significant number of consumers.

GRAS Notification
  • Information about the identity properties of
    the substance a discussion of the notifiers
    reasons that the substance is GRAS
  • Information is generally chemical, toxicological
    and, if applicable, microbiological in nature

Food Additive Petition
  • Chemical composition, substances used in
    preparation, etc.
  • Amount proposed use
  • Data that it will have intended effect
  • Methods to determine amount of additive in food
  • Safety reports

Food Additive-Safety Standard
  • General two-part food additives standard
  • Legislative history- whether substance is
    hazardous to the health of man or animal
  • Must be reasonable certainty that no harm will

The Delaney Clause
  • The Food Additives Amendment Delaney Clause
  • Asserts that no additive shall be deemed to be
    safe if it is found to induce cancer when
    ingested by man or animal, or if it is found
    after tests which are appropriate for the
    evaluation of the safety of food additives, to
    induce cancer in man or animal

Tests Showing Safety of a Food Additives
  • FDA has summarized in its Redbook the various
    types of testing that may be required to show
    that a particular use of a food additive is safe
  • Depending on the food additive and its intended
    use, the data required to demonstrate safety vary
    depending on the additives chemical structure,
    projected human exposure, and current knowledge
    about its safety

Tests Showing Safety of a Food Additives Contd
  • As long as the tests conducted do not show that
    the additive induces cancer (thereby invoking
    the Delaney Clause), FDA will review the data and
    then determine the level at which the additive
    does not cause an adverse effect
  • Then, FDA will apply a safety factor to that
    number (21 C.F.R. 170.22)

Food Additives Toxicity Testing
  • NOEL No-Observed-Effect Level
  • Highest exposure that does not produce an adverse

Safety Factor
  • Safety Factor used to account for differences
    between humans and animals
  • Generally, a safety factor of 100 is used to
    apply animal test data to man
  • May be modified based on subpopulation (e.g.
    children where it might be increased)

Hazard Analysis Critical Control Points and
Principles (HACCP)
  • a management system in which food safety is
    targeted through review control of biological,
    chemical, and physical hazards from raw material
    production, procurement and handling, to
    manufacturing, distribution and consumption of
    the end product
  • designed for use in all areas of the food
    industry (growing, harvesting, processing,
    manufacturing, distributing, and merchandising)

Genetically Modified Organisms Food
  • The FDA uses the term genetic modification to
    refer to all forms of breeding -- both modern,
    e.g. genetic engineering, and conventional
  • Bioengineered foods and food ingredients
    (including food additives) must adhere to the
    same standards of safety and adulteration
    provisions under the FDCA
  • GMO products must be as safe as the traditional
    foods/food additives in the market

Genetic Modification as Food Additives
  • FDA considers the existing statutory authority
    and regulations to be fully adequate to ensure
    the safety of new food ingredients and foods
    derived from new varieties of plants , regardless
    of the process by which they are produced.

Food Safety Modernization Act - 2011
  • Gives FDA much greater oversight over the food
    industry, including requiring facilities to
    register every two years, to develop new food
    safety plans, and to provide the agency with test
  • Gives greater incentives to the industry and
    importers to implement strong food safety
  • Gives FDA the power to mandate recalls
  • Requires FDA to develop by this coming April a
    consumer-friendly website to help identify food
    that is subject to a recall
  • Requires grocery stores to provide notices about
    recalls to customers when they are shopping