Take a look at any food label. Check out the back panel entitled, “Nutrition Facts”. It should look similar to the image on the left. Take a look at the total carbohydrate. In this sample, the total carbs is 37g, with 4g of dietary fiber, and 1g of sugar. That leaves 32g of carbohydrates unaccounted for! What are those carbs you might wonder? Well, a majority of them are added sugars.
On May 20, 2016 the FDA finalized the new Nutrition Facts label final rule for packaged foods. It was the first major update, and regulation, to the nutrition facts label in 20 years. The FDA’s regulation targeted sugars, in particular “added sugars”, and provided a major update to the amount of nutrients people customarily consume. Additionally, the nutrition facts label received a face lift.
One might naturally think of a product like a defibrillator as a medical device, but in our business, we find many companies unsure if its products are, in fact, medical devices.
The following is the first of a two part series which you may use as a helpful guide to get you through the medical device maze. First is a description of what medical devices are, and helpful hints so that you may identify if your product is regulated as a medical device. Second is a brief overview of FDA’s regulation of medical devices. The second part of the series will discuss the classes of medical devices, and the FDA registration process.
What is a Medical Device? Continue Reading
Today the U.S. Food and Drug Administration (FDA) launched a new webpage to assist the public understand the Use of Symbols in Labeling Final Rule. The final rule was issued by the FDA in June 2016 and became effective three months later.
FDA intends the final rule to be an attempt to “harmonize the U.S. device labeling requirements for symbols with international regulatory requirements. As the medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets.” This is exciting news for our clients who are Medical Device Manufacturers or Importers – as of September 2016 all medical device labeling may use stand-alone symbols!
What does the Use of Symbols in Labeling Final Rule provide for?
- Permits the use of symbols in all medical device labeling without adjacent explanatory text. This means “stand-alone symbols” may be used, but only if certain requirements are met.
- Stipulates the use of symbols, accompanied by adjacent explanatory text is still permitted. This means companies are not required to relabel their products, even if they meet the requirements for the use of “stand-alone symbols”.
- Revises prescription device labeling regulations, now permitting to use the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
- The final rule does not apply to product graphics or pictograms, such as graphics showing the steps for using a device.
In celebration of World Trade Month, Diaz Trade Law is hosting a World Trade Month Seminar Series for Compliance Professionals featuring U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) speakers.
Food Importers, here is your chance to learn practical tools for trade! We are providing the trade community a valuable opportunity to speak direct with FDA, Brokers, and legal experts to address any concerns relating to food importations and discuss the upcoming Foreign Supplier Verification Program (FSVP) requirement under the Food Safety Modernization Act (FSMA).
The TOP reasons you should attend?
- For a limited time, registration is FREE!
- You have the ability to hear DIRECTLY from FDA.
- We want the seminars to be informative and all of your questions answered. In that vain, we are currently taking ANY questions you have related to food importation/FSMA for the FDA. Please email your questions today to email@example.com!
You have a limited time to RSVP to this event for FREE!!! Yes, for FREE. We find this information to be invaluable so Diaz Trade Law is sponsoring this event, to bring it to you for FREE. RSVP today! Our full event agenda including the who, what, when, and where is below. Don’t miss it!
What is the FSVP Rule?
The Foreign Supplier Verification Program (FSVP) was created on November 27, 2015, as “a significant provision of the Food Safety Modernization Act (FSMA)”. The FSVP “shifts the burden of certifying the safety of food imports from [the] FDA to the importers themselves”. This means that importers must set up a program that verifies that both the foreign supplier of the food and the food itself will comply with United States (U.S.) laws.
DTL saved clients MILLIONS of dollars in 2016, below we list a summary of some of our compliance successes!
U.S. Customs & Border Protection (CBP)
- Assisted an importer in having $434,486.00 worth of goods seized returned to it in a RECORD 24 working days, with a signed settlement agreement with CBP in a record 17 working days!
- Assisted an importer in having $324,466.00 worth of goods seized for an underlying AES violation returned.
- Assisted importers in filing prior disclosures that were accepted by CBP, advising of errors found, and avoiding substantial penalties.
- Assisted importers in successfully responding to CBP 28’s and 29’s resulting in close outs, and no further enforcement action by CBP!
- Assisted importers in creating and maintaining pre-compliance programs to evaluate intellectual property rights and pre-report merchandise to CBP resulting in expedited entry into the U.S. with no delays or examinations by CBP.
We want to make sure you stay up to date with the hottest trade topics from 2016. Below is a summary of what you missed by category. Enjoy!
- Why Pre-Compliance is a Must
- Ongoing Hoverboard Concerns
- Yet Another Reason to Record your Trademark or Copyright with U.S. Customs and Border Protection (CBP)
- U.S. Customs – Your Personal Policeman at the Border
- Learn About “The ABC’s of Customs Seizures – Plus Top 10 Tips to Ensure Import Compliance” From the Expert!
- ISF Penalties Have Officially Arrived: Self File and Self Police
Each year, according to the findings of a Center for Disease Control and Prevention study, 48 million people (1 in 6 Americans) get sick, 128,000 people are hospitalized, and 3,000 people die as the result of food-related diseases. Instead of reacting to this news on a yearly basis, the U.S. Food and Drug Administration (FDA) decided to do something about it (although not fast enough, some would say) by enacting the Food Safety Modernization Act (“FSMA”). This law, which went into effect on January 4, 2011, aims to protect public health and ensure food safety by placing a greater emphasis on prevention, compliance, and enforcement.
We’ve summarized the seven foundational rules of FSMA for you below. The compliance elements which food facility owner/operators, growers, suppliers, importers, consignees, carriers, and/or accreditation/certification bodies should, at a minimum, incorporate into their 2017 actions plans are highlighted in red (information regarding compliance deadlines for different size-based categories of business can be viewed here). Diaz Trade Law has extensive advising clients on FDA matters and welcomes the opportunity to help your company get FSMA compliant.
Do you assume that when shopping for soaps or body washes, consumers will often times reach for products labeled “antibacterial” in hopes that those products will keep them and their families safer? If so, you would be right. The popularity of antibacterial products has grown tremendously since they first appeared on the market. According to a 1998 Gallop Study of Consumer Awareness and Perception of Antibacterial Products, 33% of those surveyed expressed the need for special antibacterial products to protect their homes from bacterial and viral pathogens. A similar study conducted by Gallop in 2010 revealed that an overwhelming 75% of those surveyed said they preferred to purchase products with antimicrobial protection. Continue Reading