Fwd: DSHEA McCain Amendment

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Liz Lipski, PhD, CCN, CHN <drlipski

Cyndi <cyndikrall

Tue, Feb 16, 2010 5:00 am

DSHEA McCain Amendment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liz's Health Tip prepared for Cyndi February 12, 2010

 

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NEW DIETARY SUPPLEMENT SAFETY ACT OF 2010

 

Last week Senator John McCain introduced the Dietary Supplement Safety Act of 2010. This will amend the Dietary and Supplement Health and Education Act (DSHEA) of 1994. I’m not entirely sure whether this is a good or bad thing. So far I’ve gotten several hysterical emails about it. I’m not an expert on this, but here are some things to consider.

Why we don’t need any changes to DSHEA:

Supplements are relatively safe. According to the American Association of Poison Control Center’s 2008 data, there were zero deaths from use of herbs, homeopathic remedies, multivitamins, and vitamins in 2008. There were 3 deaths attributed to use of minerals, and all 3 of those were from sodium or sodium salts. I’m not sure how someone got too much sodium, but one typical way is from soda ash, which is found in dishwasher soaps, glass products, and some bleaches…in other words not a supplement at all, but something that can poison you. Compare this to tobacco-435,000 deaths, alcohol-85,000, anti-biotics-75,000, use of NSAIDS (pain medications such as aspirin, Motrin, Advil)-7600.

The Poison Control Center registers every call they get. So if you find a bottle of herbs in your son or daughter’s room or backpack (why were you looking in there?) and you call, it’s registered. Calls about vitamins comprised 2.8% of all calls. Compare this to calls about cosmetics and personal care items at 9%, or topical preparations at 4.6%. If you are taking a prescription medication and you don’t feel well, you’ll probably call your doctor, not poison control, so numbers for many drug categories are relatively low.

What we need is better regulation of Supplement Manufacturers.

Currently you or I can make nutritional products in our garages or basements. The government finally passed “Good Manufacturing Practices†for manufacturing of nutritional products last year, but many companies don’t hold up to those standards. It seems to me that if companies were made to comply with the GMP’s that all ought to be well in the supplement world. To see more on what the GMP’s are go to: http://www.fda.gov/Food/DietarySupplements/

GuidanceComplianceRegulatoryInformation/

RegulationsLaws/ucm110858.htm

What John McCain is proposing: (These are my current opinions…they could change with more information.)

1. Registration of supplement manufacturers. This seems to be pretty common sense to me. How can you make sure that a manufacturer is complying with GMP’s if you don’t know who they are? It also mandates that they give lists of all products and raw ingredients that they have, product labels, and product ingredients. They’ll need to do this annually. This seems like work, but isn’t this already in their catalogs for the most part?

2. This one is a bugaboo for me. It demands that a list be made of all dietary ingredients that exist. This list will replace the current "in commerce pre-DSHEA" test. Who will make this list? How broad will it be? Is this just an excuse to take away our St. John’s Wort or high dose Vitamin C? In Canada ALL nutritional supplements and herbal products need to be individually licensed. Will this bill be a subterfuge to “harmonize†the US with Canada who has stricter guidelines than we do? Will we lose many of our supplements? People smarter than me believe that many of our body building products will be banned. I think that DHEA and melatonin will be banned.

3. If there is a new ingredient, it’s up to the manufacturer to submit documentation about why they are using it. "Registrants shall maintain a "scientifically reasonable substantiation file" available for inspection by the Secretary of Health and Human Services. Registration required 75 days prior to market. NDIs are considered adulterated unless there is a history of use or evidence of its safety.†Since nutrients and herbs are generally really safe, this all seems like overkill. And of course, there are fines involved too.

4. Adverse event reporting. This bill says that rather than submitting “serious adverse†event reports, manufacturers will have to submit reports on all “non-serious adverse†events as well. So, if I call up and say that I felt sick to my stomach, they’ll have to report that. This too, needs to be submitted annually. This seems like a waste of time and money to me.

5. Ability to recall bad products. It seems like the FDA already recalls products that cause serious adverse effects. Why do we need to duplicate that?

The only way to stop this bill is to flood the Senate with letters. If you care, send a message or pick up the phone.

If you’d like to read this bill, go to: http://www.healthfreedomusa.org/?p=4608

If you’d like to read the Poison Control Center from the CDC Annual 2008 Report: http://www.aapcc.org/dnn/Portals/0/2008annualreport.pdf

Canada Licensed Natural Health Products Database (LNHPD)http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php

 

Canadian Natural Health Products Regulations http://gazette.gc.ca/archives/p2/2003/2003-06-18/html/sor-dors196-eng.html

 

Tip Provided By:

 

Dr. Liz Lipski has a PhD and is board certified in clinical nutrition. A 30-year practitioner, author, and the Director of Doctoral Studies at Hawthorn University. She is founder of Innovative Healing Inc., author of Digestive Wellness, Digestive Wellness for Children, and many other publications.

 

 

 

 

 

 

 

 

 

 

 

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