Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?

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Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their safety and impact resistance. These products are regulated as medical devices as they are intended to mitigate or prevent the effect of the sun’s ultraviolet (UV) rays on the eyes of a person. The term “Medical Device” is defined in 21 CFR 201(h).

The following are FDA regulations that apply sunglasses. Failure to comply with them may result in CBP and FDA detaining your sunglasses at the U.S. port of entry.

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NEWS ALERT – USTR’s newly Announced List 3 Exclusion process and List 4 Comment and Hearing Process

thumbnail_image001USTR published a Federal Notice on May 21, laying out the exclusion process for list 3. USTR anticipates that the exclusion period will open up on or around June 30th. USTR estimates that over 60,000 US Stakeholders will request an exclusion for a particular product. On May 13, USTR proposed a 4th list, which slaps a 25% tariff on roughly 300 billion worth of goods. From food products to furniture, the proposed list would include “essentially all products not currently covered” under previously imposed lists including literally thousands of irrelevant goods.

If your product appears on any Section 301 tariff list there are three avenues to potentially get it removed. You may submit a comment, attend public hearings, or obtain an exclusion. Below is a big picture of the past and future opportunities get products off tariff lists:

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China Imposes Retaliatory Tariffs and US intends to Strike Back – Tell the USTR Why Your Product Should Not Be on the New List!

Pic 1As the trade war between United States and China drags into its second year, a resolution does not appear to be in the near future. In fact, following the most recent wave of escalations, the US stock market plummeted over 600 points leading into Monday, May 13.

While the trade war continues, neither side seems ready to reconcile. In early May, the two parties came close to a consensus. According to President Trump, China backed out of the deal, re-igniting tensions. In response to China reneging on the tentative agreement, President Trump called for an additional 25% tariff increase on Chinese Products on List 3.

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UPDATE: USTR Increases Section 301 Tariffs to 25% Duty for Products on List 3

China Tariffs Since September 17, 2018, the trade industry has been bracing themselves for the increase of China tariffs from 10% to 25%. The trade community has enjoyed a few months of postponements – January 1st, 2019 to March 1st, 2019. The postponements led many to believe the increase was unlikely, until May 6, when the President emphatically stated that “the 10% will go up to 25% on Friday [May 10, 2019].” via twitter. Only three days later and USTR has officially announced the anticipated 25% increase is effective on 12:01 am, May 10, 2019.

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