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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 |