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Meal
Replacements Approved By
FDA
When researching for meal
replacements approved by FDA (Food and Drug
Administration), keep in mind that the main
criteria to look for are items that would
qualify for a FDA-approved health claim. This
is largely due to the fact that a growing
number of recognized dietary supplement and
nutrition products companies are currently
working with Congress to address a concern by
America’s aging baby boomers that the
increasing cost of providing traditional health
care tends to be focused more on disease
treatment than health promotion.
If legislation is passed on
this issue, the Internal Revenue Service (IRS)
would be required to treat certain meal
replacement products and dietary supplements as
deductible “medical care” expenses.
Dietary supplements, meal
replacements and meal replacement products
approved by FDA for health claim deductions,
would include items that are intended to
promote weight loss, are low in fat, and
provide a good source of protein, fiber and
multiple essential vitamins and
minerals.
Such legislation would
represent an important step forward in
encouraging individuals to consume nutritious
products and to lose weight while enjoying a
healthy lifestyle. This is why the proposed
legislation ties deductibility to FDA-approved
health claims.
For example, FDA has
officially recognized that soy protein may
reduce the risk of heart disease when included
in a diet otherwise low in saturated fat and
cholesterol. Therefore, meal replacements
approved by FDA that are soy protein based
should qualify as a permissible medical expense
under the tax code because, when combined with
other factors, it can lead to the prevention of
disease.
The argument, then, is that
as FDA has recognized the value of meal
replacements and certain supplements by
approving health claims, so should U.S. tax
policy recognize that a number of these
products may assist in preventing disease and
should, therefore, be tax deductible. The
proposed legislation would allow for the
classification of products that prevent disease
under the tax code, so that if FDA approves a
health claim for an ingredient used in a
healthy supplement or meal replacement that
also promotes weight loss, the tax code would
recognize the product as being a medical
expenses under Health Savings Accounts (HSAs)
and Flexible Spending Accounts (FSAs)
rules.
Current Approved FDA
Health Claims for Food or Supplement
Products
Full
Claims
Calcium and osteoporosis—Must
contain 20 percent or more of the recommended
daily intake (RDI)/ daily reference value (DRV)
of the reference amount customarily consumed;
calcium must be assimilable and meet USP
standards for dissolution and
disintegration.
Folate and neural tube defects—Must be at least
a “good source” of folate, i.e., have between
10 percent and 19 percent of the RDI/DRV; meet
USP standards for disintegration and
dissolution; and cannot be made for foods that
contain more than 100 percent of the RDI for
vitamin A as retinol or vitamin D.
Plant sterol/stanol esters and coronary heart
disease—Must contain 0.65 g plant sterol esters
or 1.7 g plant stanol esters, measured per
method outlined in regulations, per reference
amount customarily consumed.
Potentially other health claims related to soy
protein and coronary heart disease or soluble
fiber and coronary heart disease.
All of these claims may have
other requirements in order to qualify for the
claim. The criteria provided above are for
reference about the general amount of the
ingredient required.
Qualified
Claims
Selenium and cancer—Must be
“high” in selenium, i.e., 20 percent (14 mcg)
or more of the RDV.
Antioxidant vitamins and cancer—Must contain 20
percent or more of the DRV customarily consumed
for vitamins E or C.
Omega-3 fatty acids and coronary heart
disease—Must contain omega-3 long chain
polyunsaturated fatty acids, eicosapentaenoic
acid (EPA) and/or docosahexaenoic acid (DHA)
but must not recommend or suggest a daily
intake exceeding 2 g/d of EPA or DHA.
B vitamins and vascular disease—Must contain
vitamin B6, B12 and/or folate in amounts
sufficient to represent 20 percent of DRV, as
well as meet USP standards for
disintegration/dissolution.
Phosphatidylserine and cognitive dysfunction
and dementia— Must contain soy-derived
phosphatidylserine of very high purity.
0.8 mg folic acid and neural tube defects—Must
contain folic acid that represents at least 20
percent of DRV.
All of the above qualified
claims must also meet certain general
requirements listed in 21 CFR 101.14, with
certain exceptions. The criteria listed above
are for general reference and are not an
exhaustive list of requirements to qualify for
the claim.
Information about qualified
claims may be found at www.cfsan.fda.gov/~dms/lab-qhc.html
.
Source:
www.naturalproductsinsider.com
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