Hello!
I hope that 2016 is off to a good start for you and your
business and that you are looking forward to great new things! While we look forward to seeing what 2016 will
bring, many industries continue to wait for action from FDA. I have listed just a few topics that various
industry sectors hope to have clarified in 2016 below.
Foods
It has been two years since FDA proposed dramatic changes to
nutrition labeling regulations (http://tinyurl.com/jjvls5q)
. Will the final rule require that ‘Added
Sugars’ be listed in the nutrition facts box as originally proposed? Industry has objected to this particularly
since the amount of sugar added to jams, applesauce, etc. can vary with the
inherent sweetness of the fruit. Since there is no lab test that can
distinguish between naturally-occurring and added sugars, it is difficult to
understand how FDA, which prides itself on being a science based organization,
can ensure compliance with this rule.
Restaurant Menu Labeling: The
publication of the final rules for calorie declarations on restaurant menus was
delayed in 2013 and then in 2015 the compliance date for this regulation was
delayed by one year to December of 2016.
Will chain restaurants really be required to post caloric values on
their menus and menu boards? While seemingly
simple, there are genuine challenges with complying with this rule. First, the accuracy required by the
regulation could be tough to meet since even though restaurants are careful
about portioning, there is variation. Second,
the regulation requires chain restaurants to list the calories on alcoholic
beverages but the wine, beer and spirits industries are not required to provide
calorie information. How is a restaurant supposed to comply? (See more on the
rule: http://tinyurl.com/j7vwkgo.)
Pet Foods: In 2007 Congress mandated that FDA take
over regulation of pet food. Since that
time FDA has been working with State pet and animal food regulators to come up
with ingredient definitions that would meet FDA criteria. As that progresses, FDA’s Center or
Veterinary Medicine is scheduled to publish draft guidance documents that pertain
to the pet food industry:
Animal Food Current Good
Manufacturing Practices
Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals
Human Food By-Products for Use as
Animal Food
Dietary Supplements
It has been four and a half years since the first draft of the
proposed guidance on New Dietary Ingredients was published (http://tinyurl.com/jtuqe4r) . In 2013 FDA has proposed that the final rule would
be published in 2014. We are still
waiting but it could be published any day!
Over the Counter Drugs
The FDA monograph that covers hand sanitizers and
antibacterial soaps and body washes has been tentative since 1994. In 2010 a lawsuit was filed to try to force
FDA to finalize the monograph. In December
of 2013, FDA published a proposed rule stating that there was not sufficient data
to support the safety of these products and that additional data on both safety
and clinical benefit was required (http://tinyurl.com/z26bgs4). The comment period closed in June of 2014 but
no final rule has been issued.
Homeopathics
Both the FDA and FTC held hearings in 2015 looking into the
regulation of homeopathic medicines. The
tone of these hearings made it very clear that both agencies view homeopathic products
as quackery and would like to change the regulatory framework for homeopathic
products. Under the current policy, homeopathic
products that comply with the Homeopathic Pharmacopoeia of the United States (HPUS)
may be marketed in the US.
Unfortunately, some companies have introduced products that do not
comply with HPUS to the market. It seems
that this is due, at least in part, to FDA’s complete failure to enforce the current
regulations that apply to homoepathics. This
industry is waiting to see whether it will have a place in the US marketplace.
Cosmetics
Will the voluntary cosmetic registration and GMP program
become mandatory? For years there have been bills introduced in Congress to
more tightly regulate the cosmetic industry.
Discussions on Cosmetic Safety Legislation between the FDA and the
cosmetic industry broke down in 2014 (http://tinyurl.com/hkmzhg7).
Will we see fundamental changes to the way cosmetics are regulated in 2016?
It can be difficult to keep up with all the possible
regulatory changes that can affect your day to day operations. My
associates and I work hard to stay abreast of FDA regulations, policies and
related issues so we can help you stay compliant. Contact us with your
questions and we’ll do our best to keep you up to date on FDA’s activities.
Please use this link
http://eepurl.com/Imbjv to subscribe to
our occasional email newsletters regarding FDA regulations and other topics of
interest to FDA-regulated companies. We
send messages targeted to the dietary supplement, cosmetic, food, OTC drug and
medical device industry sectors. You may
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Regards,
Evelyn & Associateswww.FDALabels.com
www.BioTransApp.com
