Import into US, Manufacturing, Regulations - Brain Dump

[Mikkel]

For those who are looking to import or manufacture products and sell them in the United States, I thought I would provide some valuable information in regards to getting your product ready for market. This is not all-inclusive, but things I wish someone had told me, rather than having to search far and wide for the information.

Below is a brain dump from what I have learned over the past year trying to start a biotech distribution company. I am not doing this business anymore and will be starting another business within the medical field that involves import and manufacturing. This info should not be taken as 100% fact, but only what I have learned in the process. If there is anything that is wrong or that I am misinformed about, please let me know, as I am not an expert in regulations.

LLC: Make at least one of your companies an import/export LLC, that way if one of your business ventures fails, you can continue to operate and import other products under the same LLC rather than having to close that LLC and create a new LLC and create a new bank account for every new business idea(if you are importing). This is not legal advice, just something I wish I did starting out since I now have to go through the process of closing my Biotech Distribution LLC and need to create a new LLC, which will be much broader in scope and will be able to import/export any type of product. If people have a different suggestion, please feel free to post it below.

HTS Codes: Find a customs broker who is willing to walk you through the process of importing your products. You may need to call multiple customs brokers. Don't settle for a customs broker who is not responsive. If you don't know for certain what the HTS Code for your product is, this is where your customs broker comes in. They should do it for free, though you will probably have to provide in-depth details about your product so they can accurately designate the correct HTS Code.

Finding Manufacturers: It is relatively easy to find manufacturers in China and the United States. There are good websites with good directories. That is not the case with every country. If you don't know where to go, start by reaching out to the consulate in your country that represents the country you want to work with. They may need the HTS code at this point so they know which manufacturing companies they need to reach out to. I know @Walter Hay also has a whole book on this called PROVEN GLOBAL SOURCING which I highly suggest buying. The content of that book is far more valuable than the cost of the book.

Regulations: They are a pain in the a$$, but they are a reality. The ONLY entity that can regulate you is the government unless you are trying to sell within a network(distributors, insurance, etc.). Meaning, if you are unsure if your product is regulated, reach out to the 3 or 4-letter agencies: FDA, USDA, EPA, DOT, etc.

Don't be scared to call these agencies. When you call them, they are mainly staffed by incompetent people who don't know how to answer your questions, so just keep asking for another phone number of someone who may be able to answer your question in regards to regulation.

FDA: I have only spoken to them in regard to medical devices. If you want to know if your product is a medical device, check this resource here

Once you have read the article from the FDA, I suggest double-checking with the FDA personally. You can try and go down the rabbit hole to find your answers if you want, but good luck. My suggestion, email DeviceDetermination@fda.hhs.gov

They can give a pretty accurate, but unofficial answer to whether your device is a medical device. If I understand correctly, if you are importing your product into the US, customs will also make a determination once they see the product in hand.

TIP: If you are creating software within the medical industry, you MAY be regulated by the FDA.

US Customs & Border Protection(CBP): If you are importing your product, just give them a call and let them know what you plan to bring into the US. They are generally much more friendly if you call them ahead of time and tell them what you are bringing in. They can even tell you exactly what they expect from you in regard to documentation. Your customs broker should take care of this though, but it doesn't hurt to speak with CBP.

CBP Centers of Excellence(CoE): This resource is underrated in regard to regulation information. CBP has experts based on different areas of business that are great resources. The list of Centers of Excellence and their locations are as follows:
Electronics - Los Angeles, CA
Apparel, Footwear, & Textiles - San Francisco, CA
Machinery - Loredo, TX
Petroleum, Natural Gas, & Minerals - Houston, TX
Consumer Products, & Mass Merchandising - Atlanta, GA
Base Metals - Chicago, IL
Automotive & Aerospace - Detroit, MI
Industrial & Manufacturing Materials - Buffalo, NY
Pharmaceuticals, Health, & Chemicals - New York, NY
Agriculture & Prepared Products - Miami, FL

When I spoke to the Pharmaceuticals, Health, & Chemicals CBP CoE, I asked about how to safely transport hazardous materials safely, what to look for in a warehouse to safely store these chemicals, etc. I am sure you can ask a whole bunch of questions, they will tell you if you are asking the wrong people. If that is the case, ALWAYS ask for the number of someone who would know the answer.

On the off chance you are importing hazardous materials, make sure you look into TSCA forms. I'll leave it at that, call the EPA if you have further questions(202-554-1404 or TSCA-Hotline@EPA.gov)

Please feel free to post your helpful tips on the subject or correct anything that I may have incorrect.

 

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[Mikkel]

Today I had the pleasure of speaking with a patent lawyer. Some things of interest that may be helpful to others.

Patents generally are used as a deterrent more than suing companies. The reason for this is the crazy price tag to file an actual lawsuit against a company. Large companies may sue, but small start-ups that are not wildly successful might not be able to financially.

In the world of IP and creating a product, it would be beneficial to have a "Patent Pending" before going to manufacturers and releasing information in regards to your product to the public. You can get a "Patent Pending" by submitting a provisional patent application. These last for 12 months and is generally a "cheap" way to protect your potential IP without breaking the bank. "Cheap" in this case might be ~$2,500 as opposed to the ~$10,000 Nonprovisional patent application which is the actual patent that most people think of.

A provisional patent can allow you to reach out to manufacturers and share your product without having to worry that someone will steal your product, at least they won't be able to legally.

This is all second-hand sourcing, I suggest reaching out to an actual patent lawyer with more in-depth questions. I think it is important to know the right time to get a patent. Getting a patent BEFORE you even have a working design is unnecessary since you have not even created the product. But waiting too late can lead to others stealing your IP.

A quick example of patenting IP too early. A designer I spoke with told me a story where a lady brought a basic design and her patent direct to the designer and asked him to create the product. He had to inform the client that the patented design was physically impossible to create as it defied physicals and reality. She dropped thousands of dollars on IP that was worthless. Don't be that lady.