LEGAL FAQs
A Legal Q&A: Claims
The legal department of the dōTERRA corporate office answers questions
about drug claims.
What is a drug claim?
What agencies govern claims?
What about my right to free speech under
A drug claim is a statement that is intended to diagnose,
treat, cure, or prevent any disease.
There are two agencies that govern claims made about our
products:
the First Amendment?
A quick way to clarify this is to consider whether the
condition is something you would either take medicine for
or see a doctor for. Helping a normal body function improve
is not a drug claim. Picture a vertical line with “sick” on the
left side and “well” on the right.
■
FDA (Food and Drug Administration)
■
FTC (Federal Trade Commission)
Sick
Well
A good rule of thumb is to ask yourself if the
statement takes a person from the sick side
to the well side. If so, it is a drug claim.
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dōTERRA ESSENTIAL LEADERSHIP I Spring 2014
The FDA governs the substantive claims permissible about
nutritional supplements. In other words, what you can say.
The FTC governs advertising or financial claims. Their focus
is on whether the advertising is honest. In other words, is
what you say true or is it misleading?
You do have a right of free speech under the First
Amendment. However, that right can be limited if you are
involved in commercial speech. Commercial speech means
you are making a statement in order to sell something
as opposed to making the statement merely to educate
or to comment. If you use a trademark (like dōTERRA or
Deep Blue) in connection with your statement, it is a good
indication that your purpose is to sell the trademarked
product, and you will be held to the standard of the FDA.
The FDA prohibits drug claims about any product except
those who have obtained drug approval through the FDA—
prescriptions or over the counter (OTC) medicines. You may
have a claim that is true, and thus will satisfy the FTC, but if it
is a drug claim about a nutritional supplement, the FDA will
not allow you to make the claim regardless of whether it is
true or not.
The fact that the statement is true does not matter. The FDA
looks to regulate drug claims, not false statements. Even if
the statement is true, you cannot make it if it is intended to
diagnose, treat, cure, or prevent any disease. The same is
true for a personal testimony. If the personal testimony is a
drug claim, the fact that it happened to you personally does
not allow you to get around the rule.
Are there things I can say about the product
in relation to health?
The Dietary Supplement Health and Education Act (DSHEA)
of 1994 created a new category of claims titled structure/
function claims. Structure/function claims strengthen or
benefit the structure or function of the body—a normal or
non-sick body.
For example:
“Treats insomnia” is a drug claim because insomnia is a
disease.
“Helps you sleep better” is a structure/function claim
because normal individuals can need better sleep.
“Treats bronchitis” is a drug claim because bronchitis is a
disease.
“Helps maintain good breathing” is structure/function claim
because normal individuals can still receive help to improve
breathing even though they may not be sick.
www.doterra.com
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