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About Salicylates
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DISCLAIMER -
HELP
Information and Assistance
An Approach to Getting More
Salicylate Information
Heather Vaughan & Tesa Marcon - Revised March 19, 2005
by Tesa Marcon
The contents
of this document may change according to new information. Check back
regularly and please
let me know if you hear anything new .
Everyone has their own
approach for getting information re products so do what feels comfortable for you but here
are some suggestions to work with.
1. Check Labels on products. If they are not listed in the
Sal-FreeTM
Ingredient list or our archives (with a definitive answer) ask on the
mailing list. In some cases you may have to call the company/manufacturer.
USA Food
& Drug Labelling Laws
USA Decoding the Cosmetic Label
Some smaller items like lipstick may not
have an ingredient list on the product or package in which case ask to see the larger
package the products came in and/or the information sheet that came with the products.
Either of these may have the ingredient list on them. If ever you see words such as
"and other ingredients" in an ingredient list, be sure to contact the company to
find out exactly what they are. They don't have to disclose 'proprietary'
ingredients however so get as much information as you can.
Parfum:
Key
Exceptions to label listing
More than 10,000 ingredients used in cosmetics are required, by law, to appear
on labels. The key exceptions are any of the 2,600 fragrance chemicals which are
currently listed under the catch-all term "parfum".
Most fragrances in
cosmetics are in synthetic thus will not
block Guaifenesin.
FDA
on Soaps
According to the FDA site
some soaps are not considered
cosmetics because they don't
make cosmetic claims and so don't have to list ingredients. Also, apparently
synthetic detergent bars are also considered cosmetics.
As defined in section 201(i) of the FD&C
Act, a cosmetic is a product, except soap, intended to be applied to the human
body for cleansing, beautifying, promoting attractiveness or altering the
appearance.
In section 701.20 of Title 21 of the Code
of Federal Regulations [21 CFR 701.20], the Food and Drug Administration (FDA)
defines the term "soap" as a product in which the non-volatile portion consists
principally of an alkali salt of fatty acids, i.e., the traditional composition
of soap; the product is labeled as soap; and the label statements refer only to
cleansing. If cosmetic claims, e.g., moisturizing, deodorizing, skin softening
etc., are made on a label, the product is a cosmetic. Synthetic detergent bars
are also considered cosmetics, although they may be labeled as "soap."
New OTC (over the
counter) drug labelling rules
Everyone has to start printing labels in accordance with the new OTC drug rules
no later than May 16, 2005. Every product must list ALL ingredients,
including toothpaste and sunscreen. The only exception are convenience
size products. That is - products that have less than 3 doses, such as
product samples or aspirin sold at airports where there are less than 3 doses.
All other OTC drug products must list ALL ingredients. The only problem
that one might have is if they bought a product where the label was printed
prior to 5-16-05. One would not be sure that it listed all products.
Once all old products are no longer on the shelves, we will be safe to assume
that the label lists all ingredients.
The regulations for labeling of OTC drug
products are found in 21 CFR 201.66.
Click here to access
the CFR online. From there, choose Part 200-299, then Part 201, then 201.66.
Click here for the
OTC drug product labeling requirements.
Click here for this
second link which provides for the partial delay of compliance dates for
"convenience size" products.
Click here for the
publicly available web site that contains information that you may find useful:
Leah A. Christl, Ph.D.
Regulatory Project Manager
Division of Over-the-Counter Drug Products HFD-560
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
New Canadian Cosmetic Products Ingredient Labelling
The Issue: "By November 2006,
the outer label of cosmetic products sold in Canada will have to list all the
ingredients in the product. This will help consumers make more informed choices.
It will also reduce health risks related to the use of cosmetics."
"By November 18, 2006, the outer label of
all cosmetics sold in Canada must contain a list of all ingredients. In
addition, the list must use recognized names from the International Nomenclature
of Cosmetic Ingredients (INCI) system, as found in the International Cosmetic
Ingredient Dictionary and Handbook. This naming system is already in use in the
United States, the European Union, Japan and many other countries."
2. When Calling a company ask to speak to a chemist, rather than a company rep who
will likely just tell you the same as what's written on their labels and in their
promotional material. It won't always help but it might at least get them
to disclose any unlisted ingredeints.
3. Don't start by mentioning salicylates. Many times, company reps and even chemists will state
emphatically that there are no salicylates in a certain product when in fact there are.. So try
instead to get detailed information about any ingredient that you are unsure of
(e.g., what an ingredient's original source was and the process it has
undergone).
4. Then mention salicylate if
it seems necessary - some people phrase it that they have an allergy to
salicylates
and it is dangerous for them to take anything that contains them, others say
they are taking a medication that is blocked by salicylates and so they must be sure that
no supplements they're taking contain any salicylates. The latter approach
is
straightforward and doesn't invoke responses such as asking you what exactly you are
allergic to instead of informing you of all ingredients.
Certain products are not required to list all ingredients so
we need to ask if there are any unlisted ingredients and if so, exactly what they are.
The laws regarding OTC meds labelling has been updated and all product labels
must be updated no later than May 16, 2005.
See above
for further information.
The law in America, Australia, New Zealand, & no doubt some
other countries, is that our cosmetics must list ALL the ingredients.
Canada doesn't, but new laws have been passed and they will come into affect
November 18, 2006 (see above), and probably others but we are not aware of them. However, companies
are not required to list everything in medications. Often just the "active"
ingredients are listed.
Even if the
inactive ingredients are listed and salicylates are not among them you still
might consider doing a check with the manufacturer to be absolutely sure,
especially if you are going to be taking the product for more than a brief time
span. If the inactive ingredients list 'flavor' and you are going to be
using the product for extended period of time you must determine what that
'flavour' contains. See #5 for further information.
Lip Balms can be
considered medications if they have medicinal ingredients. Products with
"medicinal" ingredients, such as medicated lip balms & rubs, medicated rubs,
fluoride toothpastes, etc. are considered medications and won't necessarily have all their
ingredients listed so we have to be very careful. How this affects toothpastes is that
fluoride toothpastes are considered medications so they can add things and not list them.
Non-Fluoride toothpastes are cosmetics so they have to list all ingredients.
Sunscreens are considered medicated products and need to be checked for unlisted homosolate, bisabolol, aloe,
Octyl Salicylate, etc. So when calling companies re
"medicinal" products, be sure to ask if there are any unlisted ingredients,
including unlisted salicylates. (Cosmetics, on the other hand, including non-fluoride
toothpastes, must have a complete ingredient info.)
Fillers in
oral medications are usually ok. The laws regarding OTC meds labelling has been
updated and all product labes must be update no later than May 16, 2005.
See above
for further information.
5. Regarding flavoring in products not
already listed on the Sal-FreeTM list:
Flavors (toothpastes, lip balms, mouth sprays, chewing gums, etc.): Find out as much as possible from the company about what is in the flavor. Especially ask
about mint (natural & artificial [piperitone]),
wintergreen (natural & artificial),
camphor, anything derived from plants (including herbs, spices,
extracts, essences, oils (some oils are Sal-FreeTM or Sal-Safe* while others are
Sal-FullTM),
and honey (if it's part of the flavoring in a topical such as lip balm).
We are told that even these salicylates are ok in oral medications and items
such as Plax, however, GG is concerned that some people may block if the
flavours are too strong. Please keep an eye on your progress if you cannot
avoid using
oral meds
containing strong salicylate flavours/fillers.
If none of the ingredients above are in the flavor of a product, and no
other Sal-FullTM or Sal-Suspect ingredients are in it either, you may decide
to try using the product at your own risk, keeping in mind that toothpastes
and other products that fall under the category "medicated" may include
unlisted ingredients and that this information can sometimes only be
obtained through persistent enquiry from a physician's office (i.e., members of the public
won't necessarily be able to obtain this information).
Fruit flavors are Low-Sal* and thus are Sal-SafeTM in flavorings. And most artificial flavors are fine
too except for those mentioned above.
The laws regarding OTC meds labelling has been
updated.
See above
for further information.
6.
Ask About Other Products You Are Interested
In
If at this point you feel certain you know the
Sal-Status* of a product and it is Sal-FreeTM, ask about other of
their products you are interested in. Always get the exact product name
and a complete ingredient listing for each product.
7.
If you aren't getting the info you need, ask who you can talk to in
the company who can provide this info.
8.
Ask them to send you the information in writing as well. You may not
end up receiving it but you just might. They think more carefully when
they have to put something in writing.
9.
If they send you email or hard copies
of their products and ingredient lists please
submit them to this site.
Sal Search Tips(Sources of
information available for help in determining an ingredient's sal status)
Submitting *Sal-Free Products to the Product list
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