Wednesday, January 28, 2015

Various Email Questions I Ask, and Pertinent Only Sections of the Replies, from Sources


I will be adding to this post.

Email: I asked Health Canada via email (an online report - you check for privacy, hc-sc.gc.ca/dhp-mps/compli), if glutathione is approved in Canada for injections. I had read this article, sciencebasedmedicine.org/are-skin-light. I sent them the article, and the second of the four links below: two, three and four, I found through research.
Reply: This is what Health Canada replied in their email to me. All bolding is by me.
"To date, Health Canada has not approved any Glutathione IV products nor have authorised its sale in Canada."
More details from the email
"Ingredient Glutathione is classified as a natural health product (NHP) under Schedule 1, item 2 (an isolate) of the Natural Health Products Regulations. According to the definition of NHP, under Schedule 2, item 5 (A substance that is administered by puncturing the dermis), substances which are administered intravenously are excluded natural health product substances and would be regulated under the Food and Drug Regulations as drugs."

Which means: (not a quote from the email reply) The advertising used some of the regulations but not the CORRECT one. That appears to me to be - VERY MISLEADING!

See Also 
Philippines
2011
"DOH-FDA Advisory No. 2011-004 || Safety on the Off-Label Use of Glutathione Solution for Injection (IV) ...
Warning to the Public:"

And 2014
"FDA Advisory No. 2014-022 || Consumer Information - Findings on Health Products Used by Spas and Beauty, Skin or Wellness Clinics"
"The use of glutathione as systematic skin whitening agent has no approval from the FDA"

And 2014
"FDA Advisory No. 2014-045 || Public Warning against Advertisement, Promotion, Offer for Sale and Use of “LUXXE WHITENING, ENHANCED GLUTATHIONE”"
http://www.fda.gov.ph/advisories/163488-fda-advisory-no-2014-045


And 2013
U.S. FDA
"Inspections, Compliance, Enforcement, and Criminal Investigations"
http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm354493.htm
"Your products identified above are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” ... New drugs may not be legally marketed in the U.S. without prior approval from FDA ... FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Furthermore, your ... products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. ... these products are misbranded ... in that the labeling for these drugs fails to bear adequate directions for their intended uses."