|
| |
| |
Nutritional
Needs
|
|
|
|
Long term
nutritional needs of bariatric surgery patients is varied and complex.
Nutritional needs may change and often require reassessment by the dietician
based on progress and tolerance. It is very important to follow the
recommendations made by your dietician and physician.
Start your
vitamins right after surgery.
Your
individual needs may vary.
Please
follow requirements below unless advised otherwise by your physician.
Click here
for the Nutritional Supplement Order Form
Vitamins
B12 Supplements
3000mcg once a week
or 500mcg per day (taken sublingually - absorbed under the tongue, not
swallowed).
Multivitamins
2 chewable children
or liquid multivitamins
or 1 chewable adult multivitamin or
liquid
Iron Supplements
65mg daily
Protein Supplements
70 grams daily (50
grams as food and 20 grams as supplementation)
Calcium Supplements
1000 - 5000mg with
Vitamin D (chewable or liquid form)
Water
Work up to 64oz.
daily
Click here
for the Nutritional Supplement Order Form
Life-long
follow-up is required on a yearly basis in order for the doctor to assess any
changes in your nutritional needs.
|
|
| |
|
|
|
|
Legal Matters and Nutrition
In the 5 years that we have been directly involved in nutrition
and weight loss surgery, there is an ongoing battle that is not
often well-addressed: the fraudulent marketing of nutritional
products.
Despite the fact that the FDA and FTC have very strict
guidelines about what a nutritional product can be and what a
company can say about their product, many businesses marketing
dietary supplements flaunt these regulations in broad daylight
with little risk of action against them. This can be very
confusing for both patients and health professionals. One could
argue that, since most of these products are benign, no one is
likely to get hurt by taking an ineffective product (loss of
money aside) - but this logic cannot apply to weight loss
surgery patients who are at a real risk of developing
nutritional problems if they do not get proper nutrition.
Here is a recent example. A couple of years ago a company
called Panacea Products, LLC began marketing their SEABLUE
products to weight loss surgery programs and patients. They
have exhibited at shows like ASBS, marketing their transdermal
creams as an alternative to oral or injectable nutrients. This
is highly problematic for a lot of reasons - for starters
transdermals are not supplements and are not studied or approved
for the delivery of nutrients. So the fact that Panacea stated
they had 95% absorption for their products and quoted patient
testimonials about being able to give up injections is not legal
and never was. Earlier this year, the FDA took notice of this
and delivered a lengthy letter to the owners of the company that
stated some of the following:
Your website indicates, "SEABLUE™
uses the transdermal method of application because it gives
you an amazing 95% absorption rate of the nutrients directly
to your body's circulation! When applied to the skin, the
vitamins are transported across the skin barrier, straight
into the cells in the bloodstream - exactly where they
benefit you most. The nutrients are rapidly and consistently
dispersed throughout your body, giving you maximum benefit
with minimum dosage."
FDA's regulations at Title
21, Code of Federal Regulations (21 CFR), § 310.3(h)(5)
state a drug may be considered a new drug because of the
newness of its dosage form or the method or duration of
administration or application suggested in its labeling.
FDA considers all
transdermal drug delivery products to be new drugs under
Section 201(p) of the Act because a transdermal delivery
system for a drug is not generally recognized by experts to
be safe and effective for any uses. Therefore,
SEABLUE Balance, SEABLUE Power, SEABLUE Vigor, SEABLUE Calm,
and SEABLUE Strength also are new drugs because they are
administered through a transdermal delivery system.
The letter further cites numerous other violations including
selling/marketing an unlicensed drug, and making unauthorized
treatment statements. (To view the entire text of the letter
click here:
http://www.fda.gov/foi/warning_letters/s6463c.htm
)
SEABLUE is one example. And they "got caught" - still, they are
not barred from the sale and marketing of their products to
patients and health professionals. The point is that each and
every day your patients are presented with choices. Products
like this are everywhere - they are professionally packaged,
professionally marketed, and endorsed by health professionals.
Because nutritional supplements are not drugs, doctors often
simply to give their patients general guidelines and decline to
give specific product recommendations. But without specific
guidelines, patients are left to guide themselves, and this may
not lead to the best choice for the long-term health assurance
of the patient.
As a health professional, it is important to carefully research
what you recommend - and to make strong recommendations based on
your best professional knowledge. Surely, we cannot make
patients comply, but we can take nutrition seriously enough
ourselves to help them take it more seriously.
If you are interested in regulatory issues in the nutrition
industry, here is a link to an article I wrote about a year ago
for Bariatric Times. Since Good Manufacturing Practice (GMPs)
Guidelines recently passed here in the US, I am working on
revising this article - but as companies have 2 to 3 years to
comply, most of this piece still holds true. If you wish to
read about the new GMPs, the second link will take you there.
Article:
http://bariatrictimes.com/displayArticle.cfm?articleID=article150
FDA GMPs (go to the bottom of the page and click on "final rule"
link:
http://www.cfsan.fda.gov/~dms/dscgmps7.html
In Health,
Jacqueline Jacques, ND
Bariatric Advantage®
|
|
|
|
