Notice of Refusal Archives - Customs & International Trade Law Firm https://diaztradelaw.com/category/fda/notice-of-refusal/ Jennifer Diaz Thu, 07 Jul 2022 14:50:38 +0000 en-US hourly 1 https://i0.wp.com/diaztradelaw.com/wp-content/uploads/2017/06/ms-icon-310x310.png?fit=32%2C32&ssl=1 Notice of Refusal Archives - Customs & International Trade Law Firm https://diaztradelaw.com/category/fda/notice-of-refusal/ 32 32 200988546 Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP https://diaztradelaw.com/heres-a-recap-of-part-ii-of-our-worldtrademonth-seminar-series-for-compliance-professionals-on-fda-fsma-and-fsvp/ https://diaztradelaw.com/heres-a-recap-of-part-ii-of-our-worldtrademonth-seminar-series-for-compliance-professionals-on-fda-fsma-and-fsvp/#respond Fri, 19 May 2017 14:47:43 +0000 https://diaztradelaw.com/?p=2960 Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

The morning kicked off with a networking breakfast where experienced and novice industry members were able to engage in meaningful dialogue about overlapping issues they experience in their respective workplaces in dealing with the topic of FSMA. We heard comments from small to large business on their current implementation strategies in place to ensure they meet FSMA requirements by FDA’s compliance dates.

The seminar promptly began at 9:00 am with introductory remarks by our own President, Jennifer Diaz. We had all attendees introduce themselves and include why this seminar was important to attend. We were glad to hear from majority of attendees that their reason for participating was to further their education on FSMA. One attendee commented, “Excited to hear from FDA about FSVP requirements and what the broker’s role is in the process.”

Next Representatives of Miami Free Zone explained their role in international business solutions as it provides users and visitors with convenient international business resources including turnkey FTZ solutions for distribution; a wholesale marketplace; an international business center environment; and premium showroom, office, and warehouse spaces. As well as providing FTZ users with flexible control over their domestic and foreign inventory, duty elimination and deferment, and high security standards for their businesses and valuable merchandise.

The first speaker was Elena O. Asturias, is a licensed U.S. Customs Broker, and Certified Customs Specialist providing customs brokerage services for imports. Elena provided top tips for custom brokers as she has been involved in logistics for over fifteen years, and has experience handling a broad range of commodities. Some helpful tips from here presentation include:

  • Make sure food facilities that must be registered with the FDA pursuant to the Bioterrorism act are registered to avoid delays upon entry into the U.S.
  • A major issue causing FDA to detain food products are product labeling violations
  • Ensure you use correct Affirmation of Compliance (AofC) Codes
    • When the entry is filed with FDA, use AofC codes to affirm the products meets specific import requirements.
    • Depending on the product type, many AofC’s are required, and must be submitted upon time of entry.
    • The AofC is a 3 letter indicator, then the qualifier which will vary in format. In some cases no qualifier is required.
  • FSVP – Unique facility identifier (UFI)
    • As of May 30th, you will need to add the UFI (Unique Facility Identifier) when you transmit the entry.
    • The AofC code being added is FSV, which will require the following:
      • DUNS number (as acceptable UFI)
      • Importer name & address
      • Email address
      • If the importer doesn’t have a DUNS number yet, you can transmit UNK “unknown” temporarily.
    • ENTRY DATA TRANSMISSION PROCESS:
    •  How Ace Works

Lundy Patrick followed Mrs. Asturias’ presentation and echoed the significance of being familiar with the importation process. Mr. Patrick is Lieutenant Commander serves as a U.S. Public Health Officer assigned to the Florida District Office of the FDA as an Imports Compliance Officer.  There were questions and answers during his presentation as the attendees had submitted questions prior to the seminar.  Here are highlights from the discussion:

  • Articles are expected to be in compliance AT THE TIME OF ENTRY. Therefore, you need to exercise due diligence to make sure the products you intend to import are in compliance PRIOR to the importation of the goods.
  • The following food imports require Prior Notice:
    • Food imported for use, storage, or distribution in the U.S. (including gifts and trade and quality assurance/quality control and market research samples)
    • Food transshipped through the U.S. to another country
    • Food imported for future export, or food for use in a Foreign Trade Zone, unless it is on the list of exemptions
  • If you fail to provide Prior Notice, the food shipment is subject to refusal and, if refused, must be held at the port of entry unless directed to another location. The importing or offering for import into the U.S. of an article of food in violation of Prior Notice requirements is a “Prohibited Act” under the laws FDA administers.
  • If a food product is assigned for examination/sampling, FDA will examine and will collect samples. Historically between 1-2% get examined/sampled.
  • Lieutenant Commander Patrick echoed the importance of product label compliance and stressed FDA does not pre-approve labels for food products.
  • He stated that the State of Florida, the third busiest district, has had over 8,000+ detention and 2200+ Refusals and provided the top reasons for food product detentions:
    • Labeling Issues:
      • Incorrect or missing statement of identity/name of the food
      • Failure to List potential allergens
      • Failure to declare ingredients
      • Failure to bear nutrition labeling or the nutrition label is in incorrect format.
    • Most common Import Alerts the FDA sees in Florida:
      • IA 16-81 – “Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella“
      • IA 99-05 – “Detention Without Physical Examination Of Raw Agricultural Products for Pesticides”
    • If Refused Goods are sold and Cannot be Redelivered for Export / Destruction, you may face:
      • Liquidated Damages and/or 19 USC 1592 Penalties

Thereafter, Giselle Jordan took the floor to discuss the hot topic of FSMA Compliance and Foreign Supplier Verification Program. Giselle is a Consumer Safety Officer at the Division of Import Operations of FDA. In August 2016, she joined the newly established Food Safety Verification Program Team. Here are highlights from her presentation:

  • Resources:
  • FSMA Sec. 301 requires importers to have FSVPs and FDA to issue regulations.
    • The goal for FSMA is FOOD SAFETY
  • Key Principles of FSVP Rule
    • Establishes explicit responsibility for importers to ensure the safety of imported food
    • Risk-based (according to types of hazards, importers, and suppliers)
    • Alignment with PC supply-chain provisions
    • Flexibility in meeting requirements (assessing activities conducted by others)
  • Purpose of an FSVP
    • To provide adequate assurances that:
      • Foreign suppliers produce food using processes and procedures providing same level of public health protection as FSMA preventive controls or produce safety provisions
      • Food is not adulterated or misbranded (as it relates to allergen labeling)
    • Who Must Comply?
      • “Importer” is U.S. owner or consignee of a food at time of U.S. entry.
      • If no U.S. owner or consignee at entry, importer is U.S. agent or representative of the foreign owner or consignee, as confirmed in signed statement of consent to serve as the importer under FSVP (“FSVP Importer”).
      • Note that the responsibility for FSVP compliance lies with the FSVP Importer and the FSVP Importer can be different from the Importer of Record.
    • FSVP Exemptions
      • Firms subject to juice or seafood HACCP regulations
      • Food for research or evaluation
      • Food for personal consumption
      • Alcoholic beverages and alcoholic beverage ingredients (7%)
      • Food transshipped through U.S.
      • Food imported for processing and export
      • “U.S. foods returned”
      • Meat, poultry, and egg products subject to USDA regulation at time of importation
      • Low acid canned food facilities (microbiological hazards only)
    • Appropriate Verification Activities
      • Must document determination, performance, conduct, review and assessment of results
      • Verification activities include:
      • Onsite audits (qualified auditor), sampling and testing of the food, a review of foreign supplier relevant food safety records, other appropriate activities
    • To qualify as a “Very Small Importer”:
      • Must meet definition of a very small importer
      • Less than $1 million/yr. in human food sales
      • Less than $2.5 million/yr. in animal food sales
      • Annually documentation of eligibility
    • Compliance Dates

Jennifer Diaz concluded the seminar with best practices for due diligence and best practices for responding to enforcement actions and FDA Notice of Action. Check out DTL’s TOP 10 TIPS for importing food products into the U.S.

For more information on how we can help you through the maze of importing and FSVP email us at info@diaztradelaw.com.

A special thanks to all our prize winner for participating during the seminar. We appreciate your involvement and interest! For pictures of the event LIKE us on Facebook.

Subscribe Today to keep up with the latest Customs and International Trade Law News.

Our next Live Broadcast webinar will be held on Wednesday, May 24, 2017 to discuss Intellectual Property Rights Violations and the U.S. Customs & Border Protections Enforcement. More information is available here.

DTL will also be at the NEI will be hosting the 3rd annual Global Trade Educational Conference held on August 7-8. NEI is bringing customs brokers, freight forwarders, NVOCCs, OTI, service providers, importers, exporters and all global logistics professionals an opportunity to update themselves on industry developments and connect with colleagues old and new. To RSVP – Read more. . .

*****This document is provided for informational purposes only and does not constitute legal advice nor does use of this constitute the formation of an attorney-client relationship.******

]]> https://diaztradelaw.com/heres-a-recap-of-part-ii-of-our-worldtrademonth-seminar-series-for-compliance-professionals-on-fda-fsma-and-fsvp/feed/ 0 2960 IS YOUR COSMETIC PRODUCT REALLY A DRUG? https://diaztradelaw.com/is-your-cosmetic-product-really-a-drug-2/ https://diaztradelaw.com/is-your-cosmetic-product-really-a-drug-2/#respond Tue, 21 Jul 2015 22:48:00 +0000

In Junealone, the U.S. Food and Drug Administration (FDA) refused the importation of over 200 different shipments of Cosmetics from 22 different countries.

The two main reasons the FDA cited in refusing entry of cosmetic products were:

  1. The products were “misbranded” (lack of adequate directions for use, nutrient content and/or health claims, anti-ageing labeling claims rendering the product a drug; or
  2. The products were “adulterated” (unsafe addition of a color additive).
Definition of a Cosmetic vs. Drug
Misbranding may come down to whether the FDA believes the product is a drug (which is often based on the products intended use, and labeling claims). It is therefore important to know the difference in the way FDA defines cosmetics and drug products, to ensure you label your products correctly.
A product designed for “cleansing beautifying, promoting attractiveness, or altering the appearance,” is generally defined as a cosmeticby the FDA.
A drugon the other hand, is as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.”
Why Cosmetic Products will be Refused by the FDA
One prevalent reason the FDA refuses cosmetic products is because of the claims cosmetic products makes rendering the product a “drug”. A health claim is one example of a type of claim, specifically it is a claim that the product affects the structure and or function of the human body. If your product makes a health claim it may be rendered and regulated as a drug by the FDA.
In response to the increase use of “health claims” on cosmetic products, the FDA re-published an import alertfor skin care products labeled as anti-aging. These products claimed to reverse the effects of aging by controlling or preventing the aging process, which is a claim that the product affects the structure and functions of the human body, and were thus regulated a drug product by the FDA.
The FDA issued a consumer update this March highlighting the difference between a drug and a cosmetic product. The purpose of this publication was to inform consumers about cosmetic products that promise too much. In order to protect consumers from this type of cosmetic misbranding, the FDA has told companies to remove drugs claims or seek FDA approval to market these products as drugs (this is a timely and very expensive process). However, the FDA further admits that there is “no one-size-fits all answer” to whether a claim is a drug claim or cosmetic claim.
Form 766
If your product is on hold by the FDA because it is misbranded, there are affirmative actions you can take. Section 801(b) of the Federal Food, Drug, and Cosmetic Act states that an importer of record may submit to the FDA a written application (using FDA’s Form 766) requesting permission to “recondition” your product. This post-compliance action, if approved by the FDA, will allow your product to be released. As approval is discretionaryby the FDA, it is important you take the right steps and hire the right expert to assist you in this process.
FTC
In addition to regulation by the FDA, cosmetic companies are also subject to regulation by the Federal Trade Commission (FTC).  The FTC issues administrative complaints when companies engage in unfair methods of competition or unfair and deceptive acts, such as deceptive advertising. The FTC has issued complaints following FDA warning letters to cosmetic companies.
You may recall cosmetics company L’Oréal USA, Inc. receiving a FTC complaint alleging deceptive advertisingof its products Lancôme Génifique and L’Oréal Paris Youth Code. The FTC has accepted, subject to final approval, an agreement containing a consent order (proposed order) from L’Oréal. According to the complaint, L’Oréal violated Sections 5(a) and 12 of the Federal Trade Commission Act because they claimed that its Génifique products were “clinically proven” to “boost genes’ activity and stimulate the production of youth proteins that would cause “visibly younger skin in just 7 days,” and would make you look as if you “slept 2 extra hours.” Similarly, L’Oréal claimed that its Youth Code products were the “new era of skincare: gene science,” and that consumers could “crack the code to younger acting skin.” L’Oréal made these claims via print, radio, television, internet and social media outlets. (It is important to note, both FDA and FTC regulate not only the product, but, also all ancillary advertisements, including websites).
The FTC’s complaint followed the U.S. Food and Drug Administration’s (FDA) warningto L’Oreal about language used in their advertisements that made the products sound more like drugs than cosmetics.
How Diaz Trade Law Can Help
Although the FDA has issued import alerts, consumer updates, and labeling guides for cosmetics, there is still no bright line between cosmetic type claims and drug claims. Unfortunately, if the FDA finds your cosmetic product on the wrong side of that line, your product may be detained and later potentially refused by the FDA. The solution is to ensureyou use “pre-compliance”, by having all products, ingredients, claims and ancillary marketing reviewed by an expert PRIOR to importation.
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