Posted by webmaster - November 20th, 2008
We have a wellness clinic in New York City and would like to offer
supplements to our clients - aminos being the main items. We have a
lab who will work with us for testing under their doctors and then
recommend what supplments would benefit the client. We would not be
prescribing but only recommending the tests and where to get the
supplements. Are there any restrictions we should know of under the
New York State law that we should be aware of?gs234789589,
Supplements are regulated under federal law, not state law. There are
some provisions under state law in New York, and I will cover those as
well. The major part is the federal regulations of dietary
supplements. Supplements, which are defined as:
? is a product (other than tobacco) that is intended to supplement the
diet that bears or contains one or more of the following dietary
ingredients: a vitamin, a mineral, an herb or other botanical, an
amino acid, a dietary substance for use by man to supplement the diet
by increasing the total daily intake, or a concentrate, metabolite,
constituent, extract, or combinations of these ingredients.
? is intended for ingestion in pill, capsule, tablet, or liquid form.
? is not represented for use as a conventional food or as the sole
item of a meal or diet.
? is labeled as a "dietary supplement."
? includes products such as an approved new drug, certified
antibiotic, or licensed biologic that was marketed as a dietary
supplement or food before approval, certification, or license (unless
the Secretary of Health and Human Services waives this provision).
An important part of what ensured safety was the FDA?s evaluation of
all new ingredients, (including dietary supplements), under the 1958
Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act
(FD&C Act).
://www.google.com/search?num=100&hl=en&lr=&ie=UTF-8&oe=UTF-8&safe=off&c2coff=1&q=FD+and+C+act&btnG=Search
The first link there is a Power Point on the act to help explain it to you.
?However, the passing of the Dietary Supplements Health and Education
Act of 1994 (DSHEA), Congress changed, or amended the FD&C Act to
include several provisions that apply only to dietary supplements and
dietary ingredients of dietary supplements. As a result of these
provisions, dietary ingredients used in dietary supplements are no
longer subject to the premarket safety evaluations required of other
new food ingredients or for new uses of old food ingredients. They
must, however, meet the requirements of other safety provisions. ?
http://vm.cfsan.fda.gov/~dms/dietsupp.html
Passed by Bill Clinton, on October 25, 1994, the DSHEA recognizes that
many millions of people in the world believe dietary supplements may
help to benefit diets and provide benefits. ?
Congress's intent in enacting the DSHEA was to meet the concerns of
consumers and manufacturers to help ensure that safe and appropriately
labeled products remain available to those who want to use them. In
the findings associated with the DSHEA, Congress stated that there may
be a positive relationship between sound dietary practice and good
health, and that, although further scientific research is needed,
there may be a connection between dietary supplement use, reduced
health-care expenses, and disease prevention. ?
There fore, the DSHEA became law. The DSHEA also promotes safety by
regulating ingredients after the FD&C Act
?A dietary supplement that contains a new dietary ingredient (i.e., an
ingredient not marketed for dietary supplement use in the U.S. prior
to October 15, 1994) may be adulterated when there is inadequate
information to provide reasonable assurance that the ingredient will
not present a significant or unreasonable risk of illness or injury.?
The DSHEA also provisions that 3?d party mater be available to the
consumer about the dietary supplement and ingredients.
?The DSHEA provides for the use of various types of statements on the
label of dietary supplements, although claims may not be made about
the use of a dietary supplement to diagnose, prevent, mitigate, treat,
or cure a specific disease (unless approved under the new drug
provisions of the FD&C Act)?
Anatomy of the New Requirements for Dietary Supplement Labels
Information that will be required on the labels of dietary supplements includes:
? Statement of identity (e.g., "ginseng")
? Net quantity of contents (e.g., "60 capsules")
? Structure-function claim and the statement "This statement has not
been evaluated by the Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent any disease."
? Directions for use (e.g., "Take one capsule daily.")
? Supplement Facts panel (lists serving size, amount, and active ingredient)
? Other ingredients in descending order of predominance and by common
name or proprietary blend.
? Name and place of business of manufacturer, packer or distributor.
This is the address to write for more product information.
http://vm.cfsan.fda.gov/%7Edms/fdsupp.html
You can read all the details of the DHSEA here:
http://vm.cfsan.fda.gov/~dms/dietsupp.html
Now, as far as New York is concerned, things get a little tougher.
Some people seem to feel that the FDA is not regulating things enough.
For example, take the supplement Ephedra.
?Sports officials, public health advocates, and politicians have been
calling to amend the DSHEA for years, to no avail. However, the high
profile death of major league baseball player Steve Belcher, whose
death was linked to a substance that contained ephedra, brought the
issue to the forefront once again.
The FDA has recently proposed a warning label for all
ephedra-containing dietary supplements; explaining the risks of
serious side effects. In addition, the FDA has proposed a new
regulation to require current good practices (CGMPs) in their
manufacturing, packing, and holding. This proposed rule includes
requirements for designing and constructing physical plants,
establishing quality control procedures, and testing manufactured
dietary ingredients and dietary supplements. It also includes proposed
requirements for maintaining records and for handling consumer
complaints related to CGMPs.
They are also sending out warning letters to firms marketing diet
supplements containing ephedrine alkaloids. These letters are being
targeted at companies that claim athletic performance enhancements.
The letters warn companies not to make false and misleading claims
about their products capacity to boost athletic performance. ?
http://www.pubadvocate.nyc.gov/reports/dietary_6-10-03.shtml
Therefore, and with good reason, some states decided to amend their
state laws to ban the sales of supplements containing anything found
harmful. It finally was banned in the entire US, under new
regulations.
New York Assembly Bill No. 6921
This was used to regulate the sale of harmful ingredients once proven.
-------------------------------------------------------------------------------------------------------
VERSION: Enacted
August 19, 2003
AN ACT to amend the general business law, in relation to banning the
sale of dietary supplements containing Ephedra to persons in New York
state
TEXT:
THE PEOPLE OF THE STATE OF NEW YORK , REPRESENTED IN SENATE AND ASSEMBLY,
DO ENACT AS FOLLOWS:
Section 1. The general business law is amended by adding a new section
391- o to read as follows:
Section 391-O. SALE OR PROMOTIONAL DISTRIBUTION OF DIETARY SUPPLEMENTS
CONTAINING EPHEDRA. 1. NO PERSON, FIRM, CORPORATION, PARTNERSHIP,
ASSOCIATION, LIMITED LIABILITY COMPANY, OR OTHER ENTITY SHALL SELL OR
OFFER TO SELL OR GIVE AWAY, AS EITHER A RETAIL OR WHOLESALE PROMOTION,
A DIETARY SUPPLEMENT CONTAINING ANY QUANTITY OF EPHEDRINE ALKALOIDS
WITHIN NEW YORK STATE, EXCEPT AS AUTHORIZED BY SUBDIVISION THREE OF
THIS SECTION.
2. FOR PURPOSES OF THIS SECTION, THE FOLLOWING TERMS HAVE THE FOLLOWING MEANINGS:
(A) "DIETARY SUPPLEMENT" MEANS (1) A PRODUCT (OTHER THAN TOBACCO) THAT
IS INTENDED TO SUPPLEMENT THE DIET AND THAT BEARS OR CONTAINS ONE OR
MORE OF THE FOLLOWING DIETARY INGREDIENTS: A VITAMIN, A MINERAL, AN
HERB OR OTHER BOTANICAL, AN AMINO ACID, A DIETARY SUBSTANCE FOR THE
USE BY A PERSON TO SUPPLEMENT THE DIET BY INCREASING THE TOTAL DAILY
INTAKE, OR A CONCENTRATE, METABOLITE, CONSTITUENT, EXTRACT, OR
COMBINATIONS OF THESE INGREDIENTS; (2) INTENDED FOR INGESTION IN PILL,
CAPSULE, TABLET, OR LIQUID FORM; AND (3) LABELED AS A "DIETARY
SUPPLEMENT" PURSUANT TO THE FEDERAL DIETARY SUPPLEMENT HEALTH AND
EDUCATION ACT, 21 U.S.C. 321, AS AMENDED.
(B) "EPHEDRA" MEANS ANY NATURAL OR SYNTHETIC FORM OF EPHEDRINE AND
EPHEDRINE ALKALOIDS.
3. (A) NOTHING IN THIS SECTION SHALL APPLY TO NONPRESCRIPTION
OVER-THE- COUNTER DRUGS APPROVED OR REGULATED BY THE FOOD AND DRUG
ADMINISTRATION.
(B) THIS SECTION SHALL NOT APPLY TO MA HUANG (EPHEDRA SINICA) SOLD OR
DISPENSED BY ANY PRACTITIONER OF ACUPUNCTURE OR ORIENTAL MEDICINE,
WHOSE QUALIFICATION TO USE MA HUANG AND OTHER HERBS IS EXPLICITLY
ESTABLISHED VIA EVIDENCE OF AN ACTIVE CERTIFICATION ISSUED TO SUCH
INDIVIDUAL FROM AN ENTITY ACCREDITED BY THE NATIONAL COMMISSION OF
CERTIFYING AGENCIES (NCCA), OR ANY PHYSICIAN OR ANY PRACTITIONER OF
ACUPUNCTURE LICENSED BY THE STATE OF NEW YORK AS LONG AS IT IS NOT
SOLD OR DISPENSED AS A DIETARY SUPPLEMENT FOR WEIGHT LOSS, FOR BODY
BUILDING, OR AS AN "ENERGY FOOD".
4. ANY PERSON, FIRM, CORPORATION, PARTNERSHIP, ASSOCIATION, LIMITED
LIABILITY COMPANY, OR OTHER ENTITY THAT VIOLATES THE PROVISIONS OF
THIS SECTION BY SELLING, OFFERING TO SELL, OR GIVING AWAY AS EITHER A
RETAIL OR WHOLESALE PROMOTION, A DIETARY SUPPLEMENT CONTAINING ANY
QUANTITY OF EPHEDRINE ALKALOIDS SHALL BE SUBJECT TO A CIVIL PENALTY OF
NOT MORE THAN FIVE HUNDRED DOLLARS PER VIOLATION, RECOVERABLE IN AN
ACTION BY ANY ENFORCEMENT AUTHORITY DESIGNATED BY ANY MUNICIPALITY OR
POLITICAL SUBDIVISION.
5. IT SHALL BE A DEFENSE THAT ANY PERSON, FIRM, CORPORATION,
PARTNERSHIP, ASSOCIATION, LIMITED LIABILITY COMPANY, OR OTHER ENTITY
THAT SOLD, OFFERED FOR SALE , OR GAVE AWAY AS EITHER A RETAIL OR
WHOLESALE PROMOTION A DIETARY SUPPLEMENT, DID NOT HAVE KNOWLEDGE THAT
THE SUPPLEMENT CONTAINED ANY QUANTITY OF EPHEDRINE ALKALOIDS, IF SUCH
KNOWLEDGE WAS NOT REASONABLY DISCOVERABLE.
Section 2. This act shall take effect on the sixtieth day after it
shall have become a law.
2003 NY A.B. 6921 (SN)
------------------------------------------------------------------------------------------------------------
Therefore, that explains some of the laws and regulations you have to
follow. In addition, as always, I will recommend speaking with a legal
professional about your specific situation. While I can guide you to
the law, I by no means know all the details of your specific
situation. Please do not mistake my advice for that of a lawyer. Here
are some legal services in your area you could check out.
I have had good luck, both using and recommending
http://www.legalmatch.com/bd/intro1.html?keyword=%28lawyers%29&engine=adwords%2145
So, there you have it. Those are the laws governing you in the US and
New York stare for dietary supplements. Once again, though, please, do
a consultation with a lawyer. Most legal firms do an initial consult
free anymore.
If this answer requires further explanation, please request
clarification before rating it, and I will be happy to look into this
further.
Nenna-GA
Google Answers Researcher
Google Searches Used:
://www.google.com/search?num=100&hl=en&lr=&ie=UTF-8&oe=UTF-8&safe=off&c2coff=1&q=new+york+dietary+supplement+law&btnG=Search
://www.google.com/search?hl=en&ie=UTF-8&oe=UTF-8&q=DSHEA,&btnG=Google+Search
://www.google.com/search?hl=en&ie=UTF-8&oe=UTF-8&q=DSHEA,&btnG=Google+Searchmany thanks for your answer but perhaps I didn't quite ask the right
question. It is not the making of the suplements or the FDA
requirements but more are we allowed by NY law to direct our cleints
to a licensed lab for testing and then recommend, based on that
testing, to take certain Aminos? The lab we use has licensed doctors
and the company that makes the aminos is licensed. Our part is meeting
the actual clients and through Hypnosis, deep relaxation and on the
physical side we want to do the testing as described above. Are we
restricted in any way form doing the LAB side of things?So, you're going to send them to a lab for testing, and once you get
the results, reccomend certain dietary suppliments?
In New York state, hypnotists need only be certified. There is no
requirement for licencing. So, as long as licenced doctors' are doing
the medical testing, and you're only reccomending suppliments that
will correct deficencies that the lab found, you should be fine. Just
make sure you follow all the DSHEA laws as well.
"Official Licensing Bodies
In New York State there is no licensing in hypnosis. A licensed health
care professional, however, can be certified in Clinical Hypnosis by
the American Society of Clinical Hypnosis or any of the four specialty
boards mentioned above. This ensures that the practitioner has met
educational standards and required training in clinical hypnosis."
References
American Society of Clinical Hypnosis. Available at www.asch.net
Hammond, D. Corydon. Learning Clinical Hypnosis. American Society of
Clinical Hypnosis, 1988.
http://www.healthandhealingny.org/complement/hypnosis_training.html
You can reccomed going to a lab for testing, but I would advise
letting all your clients know, on a signed form by both you and them,
that you are not a medical professional and you're just reccomending
the lab for testing and the suppliments. That way no one could come
back and claim you told them it was necessary to their health and they
were "swindled", for example
You're just not allowed to, say, write a prescription, for any medical
drug. You're also not allowed to, say, suggest using the suppliments
while a customer is in the hyponitized state. People have to be
informed and make free and clear choioces.
Other than that, there is nothing I can personally find in any of the
laws of New York against this. I do reccomend, once again though,
checking with a lawyer for your specific case.
Nenna-GA
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