Supple Risk

(written 2013)

“Use at your own risk” has become a common cliché, used as a layperson’s quick and easy legal disclaimer.   It’s been used to great comedic effect in many comic and late night TV host’s monologues.  It seems that our governments may be taking a similar weak approach in matters of our health, and that is no laughing matter.

I would think that consumers want safe and accurately labelled products.  They should consult medical health professionals and be able to make their own decisions on the effectiveness of a product.  Product safety is paramount, as well as quality, and efficacy statements should be based on good science.

Health Canada and the FDA (USA Food and Drug Administration) are very similar and share information with each other readily.  Their purpose is to protect the public health by regulating drugs, vaccines, medical devices, our nation’s food supply, cosmetics and dietary supplements.   The last one is where I have some concern.  Dietary supplements can include vitamins, homeopathy and natural herbs.

A recent (October 2012) Department of Health and Human Services Office of Inspector General’s (OIG) report (https://oig.hhs.gov/oei/reports/oei-01-11-00210.pdf) on FDA’s ability to regulate said:
“Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence. FDA could not readily determine whether manufacturers had submitted the required notification for their claims.  Seven percent of the supplements lacked the required disclaimer, and 20 percent included prohibited disease claims on their labels. These results raise questions about the extent to which structure/function claims are truthful and not misleading.”

This obviously suggests that there are a lot of products on the market that may be misused due to improper labelling.  It goes on further to state:
“DSHEA [Dietary Supplement Health and Education Act] does not require manufacturers to submit dietary supplements to FDA for safety or approval prior to sale. As a result, FDA has no comprehensive list of dietary supplements on the market. Dietary supplement manufacturers must ensure that their products are safe, they have evidence to substantiate structure/function claims, and that product labels are truthful and not misleading.”

This is troubling as the FDA does not conduct surveillance of supplements sold in retails stores.   It does conduct limited surveillance on the internet and monitors adverse event reports, consumer complaints and visiting manufacturing facilities.   I find that this leaves a big loophole for products to slip into the market that are unsafe.  A lot of what the FDA is doing seems to be reacting to the issues instead of solving the issues beforehand.  It’s not totally their fault though as legislature in the US and in Canada has opened those holes in the past decade or two.

Since the FDA no longer has exclusivity in determining the efficacy of products.  Therefore, certain statements not evaluated by the FDA contain a disclaimer on the label such as “not been evaluated by the FDA, and that the product is not intended to diagnose, treat, prevent or mitigate any disease”.  You may or may not have seen these statements as they are usually very small thus leading to consumer confusion on whether the product works as stated.  A paper from CIRST (Centre Interuniversitaire de Recherché sur la Science et la Technologie)
( http://www.cirst.uqam.ca/Portals/0/docs/note_rech/2006_05.pdf) in Quebec has stated
 “Opponents of such regulation have argued that the disclaimer policy strips the FDA of the authority is needs to adequately protect consumers dupery and unsafe products,”
 referring to Bruce H. Schindler’s  1998 publication “Where There’s Smoke, There’s Fire: The Dangers of the Unregulated Dietary Supplement Industry.”

With Health Canada, items under NHP regulations can, if randomized, double-blind, placebo-controlled trials are not conducted,  make efficacy claims based on “traditional uses”, i.e., anecdotal evidence of use and efficacy.  This is an unsettling thought since anecdotes are clearly not considered strong evidence in science.

Also, since Health Canada has allowed exemptions (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/exemption/index-eng.php ), there is a backlog of thousands of product on the market still remaining registered.  Health Canada and the Competition Bureau have done very little except giving notices to the manufacturers of these products.  The weak enforcement of protective policy, I feel, does little to help create a status quo that should be maintained.

So what to do?

If one is to consider taking a dietary supplement or natural health product, consult a medical health professional (like a family/general practitioner) to discuss the risk/benefits.  Also, Health Canada does provide an easy to remember way to see if a product has been evaluated by them (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/faq/question_consum-consom-eng.php) .   A product that has a Natural Product Number (NPN  123456 for example) is a safer bet.  Ones that have been on the Exempted list have a number start with EN (EN-123456 for example).  These have not been fully evaluated.   A product with no NPN number, has not been evaluated or approved by Health Canada.

Stay Safe and informed.