Globalization has brought U.S. consumers access to foods from around the world to satisfy any need or want, and as we’ve reported, food imports continue to surge. Increasing globalization has resulted in frameshifts in food production, including a transition from food supply chains to food supply webs; multiple-facility manufacturing of a single product, and vast, complex distribution networks. With the ever-increasing complexity of food production and distribution, compliance with applicable regulations and laws at each step of the production process can be difficult to achieve.

Food Allergies in the US

Furthermore, food allergies … READ MORE

FDA Regulation of Tobacco Products: Then

The road to tobacco regulation has been a long one for FDA. Although the public health consequences of tobacco usage had been observed for several decades, FDA was not very involved in the regulation of tobacco products until 1996. In 1996 FDA issued the “FDA Rule,” a set of regulations that aimed to reduce children’s exposure to tobacco. However, tobacco companies sued, claiming that Congress had not given FDA regulatory authority over tobacco products. It was 2009 when Congress passed the Family Smoking Prevention and Tobacco Control … READ MORE

The National Oceanic and Atmospheric Administration (NOAA) will require a permit and additional data reporting for certain imported fish and fishery products. Starting January 1, 2018, failure to provide the appropriate permit information and/or sufficient accompanying data can delay entry or even result in the rejection of shipments.

Who should be concerned?

If you work with the following fish species: Atlantic Cod, Pacific Cod, Blue Crab, Red King Crab, Dolphinfish (Mahi Mahi), Grouper, Red Snapper, Sea Cucumber, Sharks, Swordfish and Tunas (Albacore, Bigeye, Skipjack, Yellowfin, and Bluefin). However, you won’t be affected by the … READ MORE

President Trump has suggested a possible executive order to lower drug prices, which is to establish new trade policies that would strengthen intellectual property rights (IPR) in other countries markets. IPR refers to legal rights given to inventors or innovators of new products or technologies to protect their inventions for certain statutory time periods.

In the US, we have strong IPR protections including our 20-year patent exclusivity right for new inventions. Additionally, the US is part of an international trade agreement, Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which imposes obligations … READ MORE

The U.S. Food and Drug Administration has two roles related to its food jurisdiction: (1) ensure food safety and (2) protect against consumer fraud or deception. Over FDA’s 110-year history, the Agency’s focus has oscillated between these two areas. Since the early 2000s, FDA’s focus has largely been centered on food safety, especially as it applies to preventing and controlling for pathogenic bacteria like Salmonella, Listeria, and E. coli. This created the impression that FDA lost interest in food labeling, which has resulted in some companies paying less attention to label compliance.

However, … READ MORE

The 21st century has brought us many new technologies that have improved lives, and now AdEchoTech has added one more innovation to the list:

MELODY. 75 YEARS after the first sonography was used for medical diagnosis by neurologist Karl Dussick, AdEchoTech has designed and developed a telerobotic ultrasound system called MELODY, which makes expert ultrasound examination possible anywhere in the world that has an internet connection. MELODY uses robotic technology and the internet to connect patients with trained sonographers to image fetuses, small organs, peripheral vessels and … READ MORE

The Food Safety Modernization Act’s (FSMA’s) staggered implementation continues with two new compliance events for the animal food industry starting yesterday, September 18, 2017.

• “Large” Facilities (500 or more employees) must comply with the Hazard Analysis and Risk-based Preventive Control Rule (referred to as PCR or HARPC). This regulation requires a facility to conduct a hazard analysis and implement appropriate controls for the significant hazards.
• Small Facilities (fewer than 500 employees) must comply with the Current Good Manufacturing Practices (cGMPs) requirements. This regulation establishes baseline standards for the sanitary manufacturing of animal … READ MORE
  

The Microneedling industry developed and flourished without any substantive guidance from FDA other than periodic whack-a-mole enforcement actions. That changed today (Sept. 14, 2017) with FDA issuing a DRAFT guidance with the captivating name: “Regulatory Considerations for Microneedling Devices.”

First, what is a Draft Guidance? FDA issues guidance documents to industry (and internally for its own staff) explaining the Agency’s current position on a regulatory question. Although FDA Guidance does not have the force and effect of law, it does outline the safe harbor boundaries … READ MORE

The US drug approval process is long and costly, and pharmaceutical development companies pass the extensive costs of research, user fees, and monopoly rent on to American consumers. Essentially, U.S. patients have been carrying the water for the fixed pharmaceutical pricing schemes of the rest of the world because Congress permits it and U.S. trade policy has failed to ever prevent it. In time it is inevitable that states will be required to take on more of the cost for Medicare and Medicaid programs, including prescription drug costs, as federal funding to … READ MORE

We recently sat down with Customs and International trade lawyers Jessica Rifkin and Roy León, both senior attorneys with our sister law firm, Benjamin L. England & Associates, LLC, to get their take on the current environment with respect to the White House, Customs, and inter-agency cooperation using the ACE system.

Enforcement by Federal Agencies

“Even in 2016 we started seeing movement away from compliance towards enforcement in federal agencies like the FAA and TSA,” remarks Mr. León. And now the direction from Washington appears to be reinforcing that trend with … READ MORE

FDA has begun inspecting U.S. food importers for their compliance with the Foreign Supplier Verification Program (FSVP). The FSVP regulation has a staggered compliance date between May 30, 2017 through July 27, 2020 (depending on the food type and the foreign supplier’s size). Those subject to that first compliance date may soon be inspected by FDA, if not already.

It is our understanding that these first inspections are part of an “educate while regulate” paradigm discussed by Sharon Mayl and others, during which FDA has their regulatory “hammer … READ MORE

Three experienced regulatory team members from FDAImports.com attended the Florida International Medical Expo (FIME) in Orlando with great success. We had excellent conversations with industry professionals all along the medical device development, production and logistical supply web about serious regulatory and importation issues impacting the medical device industry.

Greater Scrutiny from U.S. Agencies
Importing medical devices and their components has already become more challenging, especially for medical device imports from countries of interest to the federal government. In particular, importers of international shipments of high value goods have received more Customs and FDA Requests … READ MORE

Starting on August 2, USDA required all shipments of siluriformes (colloquially catfish)[1] fish and fish products’ to be presented to USDA’s FSIS for re-inspection. While FSIS will perform 100% “re-inspection” for all imported shipments, the agency does not intend to sample and test 100% of the shipments. FSIS will only sample some shipments, and for the rest, FSIS will most likely release it after a document review.

This started a month earlier than September 1, the date of full enforcement published in the final rule. FSIS was forced to speed up … READ MORE

Using the argument that the acceleration of scientific innovation and expansion of global markets require it, the Food and Drug Administration (FDA) is seeking new program models to meet the demands of a changing world. According to FDA, these needs led to the recent realignment of FDA’s inspection, investigation, laboratory and import/export functions, which historically were by the Office of Regulatory Affairs (ORA) as a sister organization to FDA’s product/policy Centers. Below we will describe what FDA did and why it matters to the industry. At the outset, we will state our … READ MORE

Healthy is a word that we use every day, but when we use it in terms of food labeling, the word takes on a more important and controversial meaning. In 2015, the FDA issued a warning letter to the KIND company stating that the use of the motto “healthy and tasty” on their nut based bars was inappropriate (see our article about that case here). KIND was stunned, as their bar is made solely of fruits and nuts.

In 1993, the FDA established that a food can be called “healthy” … READ MORE

Editor’s Note:  On September 29, 2017, FDA proposed to extend the compliance dates for the Nutrition Facts panel final rule to January 1, 2020 for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales have one extra year to comply. Pending completion of this rulemaking, FDA intends to exercise enforcement discretion with respect to the current July 26, 2018, and July 26, 2019, compliance dates.

The past four years have been busy ones … READ MORE

Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for hundreds of facilities. Here are some things you need to know to ensure your renewal is completed on time.

Medical device establishments:

• The process of paying the annual Device Facility User Fee can take a couple of weeks – but don’t pay it before October 1, or it will apply to FY 2017 instead of the next year and will not be usable for renewal.
• FDA has not yet finalized … READ MORE
  

From famous ad campaigns to research touting chocolate milk as an exercise recovery drink, it seems milk is ubiquitous in the US food landscape.

As a processed animal product, milk is highly regulated; the staple product is regulated by both the United States Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA). While FDA primarily regulates milk and milk product processing and labeling, USDA’s Agricultural Marketing Service is responsible for regulating the treatment of dairy cows, the inspection of dairy farms, and administering the National Organic Program (NOP).

The NOP … READ MORE

On June 1, 2017, the U.S. Department of Commerce (DOC) published a notice to lift the antidumping duties imposed on Brazilian frozen warm water shrimp, while extending the antidumping duties currently imposed on shrimp from four Asian countries (China, Vietnam, Thailand, and India) for an additional five years. In the notice, DOC stated that the validation date for the revocation of the antidumping duties imposed on Brazilian shrimp was April 29, 2016. On the same day, Customs was notified to liquidate Brazilian shrimp entries made on or after April 29, 2016 without … READ MORE

Over the years we’ve worked with hundreds of companies to get their facilities registered and their products listed so they can meet their obligations, during which, we’ve come across a lot of misconceptions about registration.  Here are some of the primary issues we see each year.

Only the importer or exporter must register: FICTION.

The requirements for which types of facility in the supply chain must register vary by commodity, and which specific facility must register may depend on your business structure or supply chain.  However, as a rule of thumb, … READ MORE

FDA is full-speed ahead with rolling out the Food Safety Modernization Act (commonly referred to as “FSMA”).  With FSMA, FDA seeks to overhaul the U.S. regime for food safety – from a regime that reacted to safety outbreaks to one that seeks to preventive them. A key pillar in this preventive model is the Hazard Analysis and Risk-based Preventive Controls Rule (HARPC or PCR). This rule requires food facilities to develop and implement Food Safety Plans that control for food safety hazards. FDA staggered the compliance dates for this regulation; however, the “large” … READ MORE

The U.S. relies heavily on imported food to meet our demand for international cuisine and fresh produce year round.

In 2011 we reported that 20% of the food Americans eat each year is imported (How Much of U.S. Food Is Imported?). At that time FDA was just beginning to read the Food Safety Modernization Act (FSMA), which expanded their enforcement power and gave them more authority to inspect food facilities and regulate safety procedures. The Foreign Supplier Verification Program (FSVP) [go to FSVP.com to read more] and Hazard Analysis and Risk-Based … READ MORE

Customs and Border Protection (CBP) has announced and set July 8, 2017 as the effective date for reconciliation, duty deferral, drawback, collections and statement capabilities in the Automated Commercial Environment (ACE).  Please be advised that the previously used Automated Commercial System (ACS) will no longer be a CBP authorized Electronic Data Interchange (EDI) system for processing the referenced transactions.

CBP has also announced and set July 8, 2017 as the effective date for the modifications to the National Customs Automation Program (NCAP) tests for reconciliation, post-summary corrections and periodic monthly statements.

CBP has not announced and/or … READ MORE

UPDATE 07-07-2017 : The next compliance date is in March 2018. Importers should spend this time developing the programs as it takes time to work with Foreign Suppliers to build a robust FSVP program.

FDA’s Foreign Supplier Verification Plan (FSVP) first  implementation date is May 30, 2017, which has food importers and their foreign suppliers scrambling to understand what is required and when.[1] Along with that, importers want to know when FDA will start enforcing FSVP requirements and what that enforcement might look like.

Shipment Holds … READ MORE

In an email to stakeholders on May 1st FDA alerted the “deemed” tobacco products industry that FDA intends to delay enforcement of all compliance deadlines concerning newly deemed tobacco products for 3 months. Though, this did not come through the usual FDA channels, i.e updates to guidance documents and formal publication in the Federal Register, we have confirmed directly with our  FDA sources that the information is credible and provides a brief reprieve for the industry.

What Products will be Affected?

This deferred enforcement applies to newly deemed tobacco products, which include:

• e-liquids

… READ MORE

This year the FDAImports.com Government panel at Seafood Expo North America in Boston was again well attended, well reviewed and full of lively dialogue about where the Food & Drug Administration and U.S. Customs & Border Protection are going with respect to investigating imported seafood and enforcing U.S. laws, regulations and requirements. But it didn’t stop there. Panelists also spoke about POLICY under the new Trump Administration — though not officially of course.

After the historic election of President Donald Trump, Benjamin L. England, Founder and CEO of FDAImports.com, LLC and Benjamin L. … READ MORE

UPDATE: Acceptable temporary Unique Facility Identifier

FDA announced that FSVP Importers who do not yet have a DUNS number will be allowed to submit entries using “UNK” (unknown) following the May 30, 2017 compliance date. FDA is allowing this on a temporary basis only. FSVP Importers should not wait to get a DUNS number.
_______________________________________________________________________________________

The Food and Drug Administration (FDA) recently issued guidance indicating that food importers can use DUNS numbers for Foreign Supplier Verification Program (FSVP) identification. DUNS is the Data Universal Numbering System created by Dun & Bradstreet (D&B).

The Food Safety Modernization Act (FSMA) … READ MORE

FDAImports.com, A Fast Growing Consulting Practice Strengthens Resources

Miami, FL – Consulting practice FDAImports.com, LLC (http://www.fdaimports.com) and the law firm of Benjamin L. England & Associates, LLC (http://benjaminlengland.com) are pleased to announce that Roy León, has joined the firms to further develop our growing portfolio of regional and national accounts in the South Florida area. Roy brings a wealth of experience from industry, having spent the last five years at LATAM Airlines Group where he was instrumental in providing legal services to the airline and its related air carriers. Concurrently, … READ MORE

Editor’s note: This blog by John Johnson and Schevon Salmon of FDAImports.com, LLC and Benjamin L. England & Associates, LLC was originally published by greenlight.guru.

“This is a what” is not only a torturous summer-camp game, but an essential question when working to bring a medical device to market.

An incorrect answer may cause a company not just financial harm, but also subject them to FDA enforcement, like an import refusal, import alert, Warning Letter, or even judicial action.

Legal Stuff about Product Classification and Why It Matters …

Before marketing any medical device, a … READ MORE

It’s always time to think about your renewals, since state requirements do not follow a calendar year cycle for Animal Feed and Pet Food licenses and registrations. Even if you are new to the market, now is the time to get your registration in and your labels in compliance.

Each state has its own registration or licensing requirements for animal feeds and pet foods. Most states require registration of individual products, and some also require registration of the manufacturing or distributing facility. Renewal periods vary by state, so it is critical to review … READ MORE

The animal food industry experienced a sudden increase in the regulatory obligations in recent years. Through the Food Safety Modernization Act (FSMA) and its implemented regulations, food facilities must now operate under legally established current Good Manufacturing Practices (cGMPs) and risk-based preventive controls for food safety hazards.

Regulatory Framework: Before and After the new rule

Under the previous regulatory environment, the law mandated that animal food must be safe and that it could not be “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may … READ MORE

Recent headline: Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated

Our take…

Yeah…not so fast. I expect the Trump-team follow up to be, “we meant 75-80% of the really bad regulations will disappear — and most likely only in the 2fer1 program.”

So, doing the math…that means at least 20-25% of the really bad regulations will stay put, plus we will get another 35-40% new really bad regulations. That results in a net retention rate of really bad regulations of 55-65% — oh, and 100% of the just basically bad … READ MORE

Last October, FDA published a proposed rule regarding the electronic submission of labels and package inserts for home-use medical devices, which are defined as devices labeled for use outside a professional healthcare facility and include diabetic test strips, powered wheelchairs and OTC catheters. While this proposed rule is limited in scope… when considered with the recent advancements in FURLS technology, it provides an efficient mechanism for FDA to test-run a system for requiring all medical devices to provide electronic submissions of labeling and package inserts in the future.

The comment period for this … READ MORE

FDAImports.com, LLC  Founder and CEO, Ben England, is moderating a panel discussion, “Why Pick on Me??? How FDA and the Partner Government Agencies Interact on Imports,” at the 2017 Seafood Expo in Boston. This session includes current and former officials from both Customs and FDA, who will discuss cross-agency issues, ACE, and likely changes this year with FDA’s program realignment.

Panel members include:

• Benjamin England, CEO of FDAImports.com, LLC and Benjamin L. England & Associates, LLC
• Jeffrey Nii, Director of the Inter-Agency Collaboration Division in CBP’s Office of International Trade
• Peter Quinter, … READ MORE
  

UPDATE 06/13/17: Customs has set an effective date for ACE- read here for more.

Customs and Border Protection’s digital system – the “Automated Commercial Environment” (ACE) is only partially implemented.  The U.S. trade community has long been aware of Customs and Border Protection (CBP)’s goal to become a paperless automated system.  The original goal was to be implemented by the end of 2016, when ACE would become the single window – the primary system through which the trade community will submit documentation for the government to determine admissibility.  ACE was … READ MORE

Update: 2/27/2017
Based on our conversations with FDA, some facility registrations were cancelled because the US Agent failed to affirm the agency with FDA. However, we have had experiences where the US Agency was confirmed and the registration still cancelled.

Contact us if you believe your facility may have an invalid registration number.

Posted: 2/15/2017
We have become aware that FDA’s online system is erroneously cancelling active food facility registrations from around the world. This system-wide glitch has caught food facilities by surprise after industry worked hard to get their … READ MORE

Anyone manufacturing a product has a dream of building a brand. Like many other regulated industries, long-term success in the dietary supplement industry is dependent on regulatory compliance.

A recent Consumer Reports article stated that anyone with a credit card and $191 can make a dietary supplement that looks just like any dietary supplement capsules you might see in a drugstore or supermarket. It is true that the regulatory barriers to entry into the dietary supplement market are lower than those in other FDA-regulated areas – for example, FDA does not require a … READ MORE

FDA essentially banned all powdered medical gloves in the United States starting on Wednesday, January 18, 2017. On that date, not only are the gloves no longer allowed to be manufactured or distributed, but also healthcare providers must dispose of their stocks too. Everyone needs to be prepared to throw out all powdered medical gloves.

This action puts powdered medical gloves on the same level as prosthetic hair fibers – the only other banned device under FDA regulations.

What’s banned and what’s not banned?

FDA has banned three types of gloves:

(1)   powdered surgeon’s gloves,

(2)   powdered … READ MORE

On May 5, 2016, FDA finalized its tobacco deeming regulations, which will extend its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco, and pipe tobacco products. These deeming regulations are intended to help implement the Family Smoking Prevention and Tobacco Control Act (“TCA”) of 2009. While FDA’s goal is to protect consumers from tobacco-related diseases, the implementation of the deeming regulations brings about potential development hurdles for the tobacco product industry. There are two key issues that industry should monitor for new developments.

How will the deeming … READ MORE

Between October 1 and December 31 this year, all FDA-registered facilities must renew their registrations. Our team has handled registration renewal for hundreds of facilities. Here are some of our best tips for ensuring the renewal season goes smoothly.

Medical device establishments:

• The process of paying the annual Device Facility User Fee can take a couple of weeks – but pay this $3,382 fee after October 1, or it will apply to FY 2016 instead of next year.
• FDA’s system requires users to periodically change their passwords for security reasons – get started on renewal … READ MORE
  

The FDA is coming! The FDA is coming! “This sums up my initial feelings in 2009, when I got the news that FDA was making a trip to our company,” recalls Schevon Salmon, now an attorney. He was in charge of a medical device company’s compliance program during their first FDA facility inspection. Although they were audited every year for ISO 9001:13485, having FDA come in was different. “They had the power to shutter our doors, and with that a key income stream. And like most companies in the same position, … READ MORE

No one with any experience or regulatory memory at the Food and Drug Administration (FDA) or the United States Department of Agriculture (USDA) wanted the regulation of catfish (and its many cousins) transferred from FDA to USDA. USDA’s regulatory requirements are extremely expensive compared to FDA’s, and the transfer would have a relatively minimal health and safety impact. Yet it would have significant cost to the industry and would put the USA at risk of trade litigation with a number of foreign catfish exporters. The only people who were favorably impacted were … READ MORE

When it comes to leak testing for latex products (condoms, medical gloves), FDA is not infallible, and can be challenged. When testing for leak holes in shipments of imported condoms and medical gloves, the Agency adopts a composite sampling method, which increases the chance of a false positive outcome, and thus subjects these shipments to prolonged holds at the port – and, ultimately, refusal of entry into the U.S. market. The only way to avoid this is to understand how FDA sampling works and proactively challenge FDA’s decision.

AQL for Condoms and Medical … READ MORE

September 22, 2016:

Korean Air’s Board (Hanjin’s sister company in the same conglomerate group) has authorized a $60 million transfusion to facilitate Hanjin vessels’ cargo unloading in the U.S. ports. Below are quick updates regarding upcoming schedules.

• Hanjin Miami, which arrived approximately 2 weeks ago, was scheduled to approach the port of Newark on September 22.
• Hanjin Jungil was also scheduled to approach the Long Beach terminal on September 22.
• Issues surrounding return of empty containers and general chassis shortages will continue to be exacerbated.

September 14, 2016:

For the past week, the Long Beach port community was … READ MORE

Since FY 2015, Congress has continuously raised the issue of inadequate border screening of food. Particularly, Congress has been concerned with designing an import control strategy that incorporates a comprehensive system of safeguard reviews, rather than solely relying on individual FDA reviews at the port of entry. With its proposed fiscal year (FY) budget for 2017, FDA requested an $182,464,000 overall user fee budget for Foods and Cosmetics. This is a significant increase over the enacted budget for 2016, in which FDA requested $11,586,000. The overall breakdown for the increase in user fees for Foods/Cosmetics from 2016 – 2017 is … READ MORE

UPDATE 07-07-2017: The next compliance date is in March 2018. Importers should spend this time developing the programs as it takes time to work with Foreign Suppliers to build a robust FSVP program.

FDA recently published a Federal Register notice announcing delays for the implementation of certain FSMA rules. This delay affects only a small portion of the industry (among others, customer assurance and facilities coloring agricultural commodities), and the vast majority of the FSMA rules go into effect as regularly scheduled – some as soon as September 16, 2016.

“Review the federal … READ MORE

If you manufacture wearable fitness trackers or electronic massagers, determining how your product will be regulated is an important exercise. An erroneous conclusion can have a substantial impact on your business.

At the end of July 2016, FDA published a final guidance for these types of products, titled General Wellness: Policy for Low Risk Devices. The guidance focuses on the analysis that should be employed when determining if a product falls into this general wellness product category, and states that the Agency will neither examine general wellness products to determine if they are … READ MORE

UPDATE 07-07-2017: The next compliance date is in March 2018. Importers should spend this time developing the programs as it takes time to work with Foreign Suppliers to build a robust FSVP program.

Importers, get ready: in May 2017, FDA will start enforcing its final rule for the Foreign Supplier Verification Program (FSVP). The FSVP rule, designed to ensure the safety and compliance of imported food from foreign suppliers, requires non-exempt importers to establish written procedures for evaluating the hazards and risks associated with each foreign supplier and imported food. The multi-step … READ MORE

In April 2015, we commented on how FDA cancelled Import Alert 16-08 (Detention without Physical Examination of Swordfish for Methyl Mercury).  This alert instructed FDA to automatically detain all swordfish imports unless the manufacturer was on FDA’s Green List. Though the alert had been in place for almost 30 years, FDA removed it without any explanation about the Agency’s expectation for future shipments of swordfish.

Reflecting back, it appears that the removal of Import Alert 16-08 might mark the close of FDA’s long history of interactions with methyl mercury in swordfish, which … READ MORE

The Food and Drug Administration (FDA) issued the final rule for using symbols in labeling of medical devices and certain biological products.[1] The rule will be effective mid-September 2016. Specifically, the new regulations allow symbols to “stand alone”, i.e., without adjacent explanatory text, under certain conditions. This goes a long way to harmonize with foreign government requirements, including the European Union (EU). Medical devices labeled with “stand alone” symbols may be imported into the US provided that they meet the FDA conditions below.

Manufacturers may continue to use symbols accompanied by … READ MORE