Search This Blog

Wednesday, February 17, 2016

Waiting on FDA

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.

It has been two years since FDA proposed dramatic changes to nutrition labeling regulations ( .  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:

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  As that progresses, FDA’s Center or Veterinary Medicine is scheduled to publish draft guidance documents that pertain to the pet food industry: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 ( .  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 (  The comment period closed in June of 2014 but no final rule has been issued.

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.

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 ( 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 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 subscribe to one or all of the newsletters and you may unsubscribe at any time.

Evelyn & Associates

No comments:

Post a Comment