How To Sustain Regulatory Compliance
In Food & Beverage Labeling
By Jim Scanio
Managing regulatory compliance has always been a challenge for organizations, particularly
those in the food and beverage industry.
The stakes are even higher today as
companies must balance adherence
to strict — often exhaustive, always
changing — policies and procedures
with the desire to embrace digital
transformation and accelerate business to
keep up with growing global competition.
This leaves the regulatory affairs, as
well as quality and compliance, personnel
in the middle, serving as the conduit
between standards bodies or agencies
and senior leadership representing
manufacturing, supply chain and other
key operational functions. The back-and-forth can be dizzying as one side expects
compliance at all costs while the other
desires getting product to customers
faster and more efficiently than ever.
Labeling is one such area that
crosses departmental boundaries.
For manufacturing and supply chain,
the barcode label is the passport that
enables the fast identification, transport,
tracking and delivery of product — from
production line to end customer. For the
regulatory manager, that same label
must conform to myriad regulations and
standards, many of which are a moving
target due to constant change.
In food and beverage, the FDA’s Food
Safety Modernization Act (FSMA) expects
full transparency of how products are made
and where they are at all times in the
distribution and consumption layer — and
labels must support that effort as well.
Of course, the nutrition label itself must
adhere to an array of regulations to provide
consumers with the information they need
to make safer, more informed decisions.
Managing Global Standards,
In addition to complying with these
strict, industry-focused regulations,
companies must also pay attention to
global standards and regional specific
requirements. This gets particularly
complicated as you enter emerging
markets where countries like Brazil, China
and India, as well as growing economies
in Africa, continue to set unique label
requirements for their trade partners. As
such, regulatory departments must be
more vigilant than ever in keeping up with
Growing role of GS1: GS1 is one of
the world’s largest organizations that
develops and maintains standards to
enable trade partners — manufacturers,
suppliers, distributors and retailers — to
use a common language as products
traverse from one party to the next. With
more than a million members in over
100 countries, GS1 provides, among
other things, unique numbering and
identification systems, as well as barcodes
that are captured on labels to help improve
visibility and traceability across the
international supply chain.
Unique rules by country: Management of
regulations and standards gets especially
tricky as you expand operations into other
regions of the world. Many countries expect
you to meet their strict requirements for
language, symbologies, transactional data
and other criteria. The reasons for these
stipulations are valid — they improve the
speed and efficiency in how products move
through the supply chain — but they also
present a set of challenges.
The Perils And Pitfalls
The risks associated with non-compliant labeling vary, but all are
damaging, if not potentially crippling.
Health and safety issues: First and
foremost, you never want to put lives in
danger due to mislabeling. Unfortunately,
there are too many stories in recent years
in which products were labeled incorrectly
resulting in sickness — and even death.
Whether it was allergen omissions on food
labels, or the infiltration of counterfeit
drugs with inaccurate labels, the losses
are tragic and usually lead to lengthy,
Product recalls: When food, chemicals
and drugs are mislabeled, companies
typically have to go through an exhaustive
recall process, which takes up valuable
resources, throws off production
schedules and greatly reduces profitability.
Most companies have recall procedures
in place — but that doesn’t mitigate the
significant impact to operations.
Fines and penalties: Regulatory agencies
like the FDA warn violators of fines
(upwards of $500K or more), seizures,
suspension or revocation of licenses, and
criminal sanctions. While there’s been a
bit of a grace period allowing companies
to get their processes in place for some
regulations, you can be sure agencies will
be looking to crack down on violations in
the coming months.
Supply chain disruption: A ripple effect
of unforeseen events like product recalls
or seizures is the interruption to the flow
of goods across your supply chain. What if
product is confiscated or even destroyed
when crossing international borders?
Not only does this impact your bottom
line, but it can hurt relationships with