FDA Regs, Relief Factor & my small business

[Laurie BlombergStudent]

I have a very small company and sell an all natural topical pain reliving spray & lotion. I use “pain” in the product name and have been told I need to change it & stop making claims referring to pain. In discussion with team members I have been referred to “Relief Factor” and how they claim their product relieves pain many times on their website. Can anyone help me understand why they can and I cannot? I definitely do not want the ire of the FDA coming down on me but on the other hand I really hate to change the product name because it is a great name. We have disclaimers on our website that it’s efficacy varies from person to person and doesn’t work at all for some. My marketer believes our disclaimers are sufficient but I certainly don’t want to be sued for fraud!

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Elizabeth Prackert

[Greg BoggsStudent]

An easy way to change the name without changing the name is to change the spelling. Pain Relief is a claim, Pane Relief is not

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Sally Knox, Elizabeth Prackert, Laurie Blomberg, Laura L. Bergeson

[Laurie BlombergStudentTopic Author]

I will keep that in mind. I don’t think our marketing guy will be wanting to do that but it may be a necessity. I am just wondering though why Relief Factor can do it and spell it the correct way? They are HUGE!

[Elizabeth PrackertStudent]

We have a similar scenario in Australia..We can’t make any claims about anything we have to deal with the TGA here Therapeutic Goods Assn. You can say something soothes but we cant mention pain either.I have made a Olive leaf salve and I am planning to call it Barbed Wire Balm. Great for cleaning up wounds and inflammation. Gets the point across especially as I am in a rural area. The powers that be are soooo scared of herbs.

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Joanne Fletcher

[Dr. Patrick JonesHomestead Instructor]

“Relief” isn’t really a medical term so long as they don’t imply what one is getting relief from. That said, the rest of their marketing where they talk about what it’s doing for people is very much at odds with FDA guidelines. Why do they do it? Because the FDA hasn’t come knocking on their door yet. Someday they might. There was a large essential oil company that used to make all kinds of claims in their product literature and got into a lot of hot water with the FDA.

See this lesson for some guidelines on how not to get into trouble:

Ethics & Legalities of Herbal Practice

Don't use herbs or combine herbs with medications or use them during lactation or pregnancy without talking with your healthcare provider.

• This reply was modified 1 year, 5 months ago by Dr. Patrick Jones.

[Susan BrygStudent]

While we are on the topic of what is ‘allowed’, I notice that tinctures often include the term ‘ethanol’ as the ingredient name for an alcoholic menstruum.  If I am selling ‘ethanol/vodka’ aren’t I, in effect, selling alcohol without a license?  What if a minor bought it?  What are the legalities here?

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Wendy Stuner

[Dr. Patrick JonesHomestead Instructor]

I’m not aware of any state in the US that regulates tinctures sales as “alcoholic beverages”. If they did, they’d have to start regulating vanilla extracts and such as well. Some states have regulations about manufacturing tinctures but you’d have to look at your local situation. In Idaho we aren’t regulated in those areas.

Don't use herbs or combine herbs with medications or use them during lactation or pregnancy without talking with your healthcare provider.

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Wendy Stuner, Susan Bryg

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