| FDA
Regulations have been the hottest topic floating around our nation’s
capitol since Obama took office. Furthermore, last month’s recall
of Hydroxycut heightened the importance of these regulations. In the
past weeks, the FDA has condemned and forfeited $1.3 million worth
of dietary supplements due to inadequate information. They also seized
more than $1.5 million of adulterated food products due to filthy
conditions and obtained permanent injunctions barring two companies
from manufacturing and distributing unapproved drugs. As a result,
Hydroxycut and Raptiva voluntarily removed their products from the
US market.
The FDA is responsible for regulating and supervising
the safety of food, nutritional supplements, drugs, vaccines, cosmetics,
blood products and other medical products. The FDA regulates more
than $1 trillion worth of consumer goods, of which 25% is in the
United States. This includes $466 billion in food sale, $275 billion
in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements.
Much of the expenditures are for goods imported into the United
States; the FDA is responsible for monitoring a third of all imports.
The FDA has requested $3.2 billion, a 19%, budget
increase for the 2009-2010 fiscal years. This increase will go towards
protecting America’s food supply ($259 million), safer medical
products ($166 million), current law user fees ($74 million), and
follow up on biologics and drug importation ($5 million).
Recent scandals such as the Peanut
Butter Salmonella, Pet Food Melamine and the Tainted Milk Recall
have awakened the FDA from its lax position and it is now preparing
to protect consumers at all costs. With Obama appointing new leaders,
an increase in funds and the new cGMP regulations, the FDA will
be auditing manufactures for proper product handling, sanitary conditions,
product contamination, proper labeling and most importantly false
claims.
What can companies do to keep production flowing
smoothly? Follow the rules. These policies and regulations have
been in place for many years but were rarely enforced. It is not
clear if it was a lack of resources or political importance that
stopped the FDA from enforcing policies. However, the movement is
now marching towards policy enforcement and consumer safety at full
speed.
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