Best Practices: Where Industry Should
Lead on Ensuring Proper Testing & Auditing
Stephen F. Sundlof, DVM, PhD
Senior Advisor for Animal and Food Safety
EAS Consulting Group, LLC.
Topics
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FSMA Changes
Foreign Supplier Verification
Domestic Supplier Verification
Accredited Third Party Audits
Accredited Laboratories
New Dietary Ingredients vs GRAS
substances
FSMA Changes
• Functional Foods: Major changes
– Preventive Controls
– Foreign Supplier Verification
– Third Party Audits
• Dietary Supplements: Minor changes
– Biennial Registration
– Maintain list of foreign suppliers
– Ensure importer identification at entry
– Maintain records
What FSMA does not mandate
(yet)
• Product testing
• Environmental monitoring
• Domestic supplier approval and verification
Supplier Qualification/Verification
Programs
• DS Ingredient Supplier Qualification
• Food Foreign Supplier Verification
• Food Supplier Approval and Verification
Dietary Supplement Supplier
Qualification
• DS manufacturer responsible for to verify
supplier’s compliance to GMPs
• Standards for “qualification” not clearly
defined
• Private third party auditors and certification
bodies developing their own standards
Foreign Supplier Verification
(FSVP)
• FSMA requires food importers to verify
that their foreign suppliers produce food at
the same level of public health protection
as required by domestic producers by:
– Annual on-site auditing???
– Sampling and testing
– Review of foreign supplier food safety
records
– Other appropriate procedures
FSVP – 2 Options
• Proposed rule on FSVP presents 2 options:
– Option 1
• Requires importer to conduct annual on site audit of
the foreign supplier if there is a reasonable
probability that the food will cause serious adverse
health consequences in humans or animals
– Option 2
• On site audit is an option but not a requirement for
all foods except those requiring certification or as
part of a Voluntary Qualified Importer Program
Supplier Approval & Verification
• Applies to domestic suppliers of food and
food ingredients
• Not required under FSMA, but FDA has
requested comments in the Preventive
Controls proposed rule as to whether it
should be mandatory
• If required in the final rule, will be very
similar to FSVP
Industry Leadership
• Should the food and DS industries petition
FDA to harmonize supplier
qualification/verification programs?
• If a supplier produces ingredients for both
dietary supplement and food manufacturers,
is the supplier subject to both food and DS
qualification/verification?
Accreditation of Third-Party
Auditors/Certification Bodies
• Private third party auditing of food and DS
suppliers and manufactures is a rapidly
growing enterprise
• Quality of third party audits range from
rigorous to poor
• Until FSMA, FDA did not recognize third
party audits and did not establish
standards for accreditation or certification
Accreditation of Third-Party
Auditors/Certification Bodies
• Proposed rule sets out a framework for
how FDA will:
– Recognize accreditation bodies
– Provide accreditation of third-party
auditors/certification bodies to conduct food
safety audits
• Applies only to foreign food facilities
Accreditation of Third-Party
Auditors/Certification Bodies
• FDA accredited third-party certification
required when:
– Importing high risk foods that require
certification
– Importers establish eligibility for the Voluntary
Qualified Importer Program (VQIP)
• Certified audits may be used to comply
with FSVP requirements
Cost of Accredited vs.
Unaccredited Audits
• Accredited $3,600
• Unaccredited $2,700
Benefits of a Single Standard
• “Widespread participation and broad
acceptance of audits and certifications
under the FDA program help increase
efficiency and reduce costs, by eliminating
redundant auditing to assess foreign
suppliers’ compliance with the Federal
Food, Drug, and Cosmetic Act.”
Industry Leadership
• FDA third-party accredited audits are likely
to become the “gold standard” for the food
industry
• Should FDA create a similar accreditation
program for the DS industry?
Laboratory Accreditation
• FSMA requires certain food testing to be
carried out by accredited laboratories and
directs FDA to establish a program for
laboratory accreditation to ensure that
U.S. food testing laboratories meet highquality standards
Laboratory Accreditation
• FDA has not yet fully developed its
thinking or rulemaking on the FSMA
requirement for laboratory accreditation so
any interpretations of requirements are
premature at this time.
Industry Leadership
• When FDA promulgates standards for
laboratory certification they will likely
become the “gold standard” for the food
industry
• Should FDA create a similar certification
program for the DS industry?
New Dietary Ingredients vs GRAS
Substances/Food Additives
New Dietary
Ingredient
GRAS
Substance
Food Additive
Premarket
Approval
No
No/Yes
Yes
Notification
Yes
Yes
No
Self-Affirmation
No
Yes
No
General
Recognition
No
Yes
No
Safety Standards: A Distinction
without a Difference???
• GRAS and Food Additives:
– Reasonable Certainty of No Harm
• New Dietary Ingredients:
– Reasonable Expectation of Safety
• <25% of NDI notifications receive “no
objection” letters from FDA
GRAS Workaround
A legal theory to avoid NDI notification*
1. Self-affirm that the NDI is GRAS
2. Introduce the GRAS substance into food
3. Market food containing the GRAS substance
for some period of time
4. NDI now exempt from notification
requirements because of GRAS status
*I
neither condone nor recommend this approach
Industry Leadership
• Request that FDA clearly
delineate/differentiate Reasonable
Certainty of No Harm from Reasonable
Expectation of Safety
• Provide FDA with suggestions on how to
differentiate, e.g. greater reliance on
published studies for NDIs
Summary
• Changes brought about by FSMA will have
significant impact on DS and functional food
industries
– Alignment of supplier qualification/verification
programs
– FDA recognition of third-party audits/certification
– FDA certification of laboratories
• NDI notification requirements substantially
same as GRAS/Food Additives
Thank You