Denise Calle

Denise Calle is a bilingual Associate Attorney with Diaz Trade Law, P.A. Denise practices Customs and International Trade Law. She assists foreign and domestic businesses, manufacturers, distributors, importers, and exporters with regulatory compliance, trade, and enforcement matters. Ms. Calle is a published co-author, professional speaker, and has been quoted in the press on the topic of importing tobacco products. Denise has developed and presented trainings on U.S. Customs and Border Protection (CBP) & U.S. Food and Drug Administration (FDA) compliance and enforcements as well as customized training focused on the Trade War with China, Intellectual Property Rights, Dietary Supplements, and more.

With regard to imports, Ms. Calle’s work includes:

“Pre-compliance” – prior to importation, Ms. Calle confirms clients are compliant with laws and regulations enforced by U.S. federal government agencies, including

• U.S. Customs and Border Protection (CBP), U.S. Food & Drug Administration (FDA), U.S. Department of Homeland Security (DHS), U.S. Environmental Protection Agency (EPA), Alcohol and Tobacco Tax and Trade Bureau (TTB), the Federal Trade Commission (FTC), the Consumer Product Safety Commission (CPSC), the Department of Justice (DOJ), the Federal Communications Commission (FCC), the U.S. Department of Agriculture (USDA), and other federal organizations. Her work also covers assisting clients with intellectual property right (IPR) protection through recordation of registered trademarks or copyrights with CBP.
• To that end, she provides counsel to clients in areas such as strategic business planning, product development, advertisement and promotion / label review, and related issues. She affords advice to clients regarding use of “reasonable care” and conducts the following assessments:

         - Admissibility assessment – determine whether the commodity at issue may be entered into the U.S. commerce and compliance with U.S. Federal Agency laws and regulations.

         - Classification – proper assessment of the Harmonized Tariff Schedule of the United States (HTSUS) and anticipate duty rate based on the product description.

         - Country of Origin – accurate determination of a product’s country of origin and marking which may impact admissibility or the amount of duty imposed. Conduct review to determine qualifications under trade preference programs.

• Ms. Calle’s ensures companies are in compliance with FDA by reviewing product labeling, assisting with registration and any necessary pre-market approval requirements for food, cosmetic, over the counter drug, dietary supplements, alcohol, tobacco and medical device products.

Enforcement – Ms. Calle advocates for clients in audit and administrative proceedings before CBP and FDA.

• She assists clients with CBP detention and seizure cases, penalty mitigation, drafting prior disclosures, responding to CBP Requests for Information (CBP Form 28), Notices of Action (CBP Form 29), and submitting Protests to CBP, requesting ruling requests from CBP, and requesting scope rulings to determine if a product is subject to an Anti-dumping/Countervailing order. With regard to FDA enforcement, Ms. Calle has assisted in representing clients in FDA detentions, refusals, and responses to warning letters.

As for export law, Ms. Calle has knowledge of U.S. export control laws. She assists clients before the Bureau of Industry & Security (BIS) and the Office of Foreign Assets Control (OFAC).

• Ms. Calle assists clients in conducting assessments of existing export compliance programs and policies and develops comprehensive, individualized export programs.
• She is trained on current legislation regulating doing business with Cuba. Ms. Calle has conducted evaluation of international and U.S. clients’ proposed transactions to determine whether export control licenses are required and assists in applying for export licenses with BIS and OFAC when necessary.

During law school Ms. Calle worked at the United Nations as a legal advisor for the Delegation of the Holy See at Third Committee of the General Assembly on Social, Humanitarian & Cultural affairs, where she assisted experts, attorneys, and investigators in the areas of trade violations, advancement of women, promotion of fundamental freedoms through the elimination of racism and racial discrimination, crime prevention, criminal justice, and international drug control. Denise has solely practiced Customs and International Trade law since law school. She was a law clerk at our firm since inception. She gained valuable experience with client services and business management prior to law school when she worked as an operational manager at an Entertainment Firm located in Miami Beach.

Ms. Calle’s interest and hobbies include being a foodie, practicing Kundalini and Bikram yoga, personal development, women’s support and development, traveling, gardening, podcasts, and interior design.