Legal Question in Business Law in California

I would like to create and sell dietary supplements from home, what laws do i need to abide by to be able to sell internationally. Are there any licenses or certificates that I need?


Asked on 8/26/12, 7:56 pm

2 Answers from Attorneys

Bryan Whipple Bryan R. R. Whipple, Attorney at Law

First, I'd guess that there may be somewhere around 50 lawyers in the entire United States that would be able to answer this question based upon true, accurate, current and complete knowledge of the subject, and most of them are either gainfully employed by large drug firms like Merck and Lilly, by smaller food-supplement companies trying to make it big time, or working for major law firms at $400 an hour (or more). I'd be surprised if anyone at LawGuru or other sites like it would know even a large part of the answer, or even be able to research it.

However, based on a general feel for the subject, and without any specialized knowledge whatsoever, I'd say that "creating and selling dietary supplements from home" would be a very difficult proposition to carry out on an international scale. Every country is going to have its own set of rules and standards. Many would demand inspections of the premises where the supplement was being prepared. Some would demand proof of effectiveness. Whether your product was considered a food or a drug, each country (or bloc, e.g. Europe) would have varying requirements.

If you are serious, I'd think a couple of starting points would be (1) contact the U. S. Food & Drug Administration with particulars on your proposed business, including proposed contents of each supplement, production methods, and claims to be made regarding its purpose and effects on human health; and (2) contact the trade representatives of countries where you propose to sell your products at either their embassy in Washington, D.C. or, for the larger countries, there may be trade reps at the country;s regional consulates, e.g., in L.A.

Be prepared to answer a jillion questions about raw materials, preparation, sanitation and safety controls at the point of manufacture, proof of claims for health benefits, packaging, shipping, payment of duties, advertising claims, insurance, testing, medical supervision, etc.

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Answered on 8/27/12, 8:52 am
Terry A. Nelson Nelson & Lawless

Start your thinking with inquiry about requirement for approvals to ...

FDA

then move on as necessary to

FTC

EPA

regional air and water quality authorities

US State Dept / US and foreign Customs

patent, trademark, and copyright counsel

Corporate Commissioner

IRS

FTB

city, county and state business licenses

and the list will continue to grow.

Pharmaceutical mfg's estimate about $50M per drug to successfully bring to market. Supplement makers estimate anywhere from $100's of thousands and up.

Ignore the federal or state regulatory rules at the risk of jail and loss of all profits.

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Answered on 8/27/12, 1:25 pm


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