Co-Authored by Denise Calle
Whether you are new to importing or seasoned, this one-hour webinar is a must attend. Register today to hear directly from this specialized, expert trio on the “Top 10 Tips When Importing to Ensure Compliance” with real case studies:
Background on Food Facility Registration
The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food facility registration requirements in the FD&C to require domestic and foreign facilities to submit certain additional new information to the FDA and renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.
On January 14, 2021, the United States Food and Drug Administration (FDA) kicked off the year with a set of Webinars for the trade community. Specifically, the Center for Drug Evaluation and Research (CDER) held its first annual Small Business and Industry Assistance (SIBA) Compliance Conference. The topics covered various areas dedicated to compliance including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance.
Co-Authored by Sharath Patil
Background on Securing Information Technology & Communications Supply Chains
For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.
On Wednesday, January 6, 2021, the Office of the United States Trade Representative (USTR), announced the revision of its Section 301 Action: Enforcement of U.S. WTO Rights in Large Civil Aircraft Dispute (86 FR 674).
On December 21, 2020, the Food and Drug Administration (FDA) proposed a rule to revoke the Standard Of Identity (SOI) for French dressing. FDA found that French dressings’ current standard of identity “no longer promotes honesty and fair dealing in the interest of consumers”. Effectively the amending of the SOI may allow producers more flexibility, keeping the market competitive with nonstandardized foods.
According to the Federal Register Notice, the proposed rule would not require anything new from salad dressing manufacturers. Rather, by providing the flexibility for innovation, the amendment to French Dressing’s SOI presents an opportunity for social benefits at no cost to the industry or consumer.
On December 29, 2020, the Office of the United States Trade Representative (“USTR”) announced long-awaited extensions to a limited set of previously granted exclusions (for COVID-related products), that were set to expire on December 31, 2020. Meanwhile, importers across non-COVID industries are continuing to await guidance on their tariff exclusion extensions that are set to expire on December 31, 2020.
In the household goods and services industry? Did you know you have to import your goods and services in compliance with the Bureau of Household Goods and Services (BHGS) regulations? Manufacturers or wholesalers of any article of upholstered furniture bedding, or filling material manufactured outside of the United States for the purpose of sale or resale in California, whether it be through employees or agents, fall within this category.
Despite Haiti’s challenging socio-economic, as well as political climate, Haiti remains one of the most open economies of the Caribbean seeking foreign direct investment (FDI). Haiti’s legislation encourages such FDI with the assurance that the same rights, privileges, and equal protection are provided to local and foreign companies. The current president of Haiti established and announced “Seven Priority Axes” for the development of Haiti. One of which is in the electricity (e.g., Hydro, Solar, Natural Gas and, of course, Petroleum) sector.