The E-commerce marketplace space is fantastic in the USA.

I see a lot of people dipping their toes into it.

Some come out successful, and others not so much.

I feel like a major part of the success depends on advertising.

But also what you are selling in the end.

And in this particular case, our client was selling something unique.

Our client wanted to import peptide products and sell them online in the US market.

They saw some similar e-commerce vendors available.

And wanted to get legal advice on the same and risk mitigation strategies.

That's where we come in.

Problems:

1) Disclaimer Dilemma

The client was aware of other competitors in this space.

The client also noticed the use of several disclaimers on the platform.

They wanted to know if they needed to do the same to stay out of legal trouble.

2) Peptide Precautions

They were all about selling peptides online but weren’t sure about the fine print.

What precautions and disclaimers were needed to sell them online?

They wanted to be aware of it.

3) Is it Legal?

Overall, the client needed us to advise them on the best move forward.

And IF their idea is feasible legally.

Or were there red flags they were missing?

Solutions:

(1) FDA Approvals

The peptide products the client was intending to import and sell came under the category of drugs, and FDA regulations came into the picture.

We advised the client on the legality of selling peptide products.

Either they could get product approval for their own brand. This would cost them millions.

Or they could sell the existing approved brand names, which was a better alternative.

We also provided them with the list of FDA-approved drugs list for the particular peptides.

(2) For Research Use Only

Such peptide products could not be sold for “human use” without FDA approval.

And that's why other e-commerce vendors were selling it under the garb of “Research Use Only”.

We referred to the guidance document of the FDA on Research Use Only (RUO) drugs.

And also advised the client on the nuances of selling under the “Research Use Only” label.

We further advised the client about the consequences of using this approach.

(3) Risk Mitigation

We advised on the implication of the RUO label for products and what the FDA looks at while examining such products.

We also shared some of the past indictments and investigations by the FDA due to misbranding.

We further advised on what steps could be taken if the client is actually wanting to sell under the “RUO” label.

We also provided different risk mitigation strategies.

For example, labeling, representations, logistics, marketing aspects, disclaimers, and website documents.

Our job as legal advisors many times involves assessing risks associated with a client’s plans.

And telling them the best strategy forward.

And if the plan is outrightly not legal, then tell them the hard truth and protect them from any future consequences.

If others are doing something in the market, it’s not an excuse to imitate.

The risks associated were far too great.

Ultimately the decision was up to the client.

We gave them the options and the clarity on everything they needed to know.

And with the given information and our opinion, they could make the next move.

I hope you enjoyed this week's case study!

If you ever need a custom solution like this, don't hesitate to reach out! :)

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