Labeling dietary supplements

What if you could put the benefits of tough exercise in a pill and sell it Supplement companies claim to have done just this. Pharmacies, health food stores, and the Internet are flooded with countless products claiming to help the body get rid of fat. So, do they work As with all supplements, that s an ongoing matter of debate. Fat burners and metabolism boosters are labeled "dietary supplements," since the FDA has yet to approve a medicine for this purpose. 

The EVA warns the public not to take ephedrine-contain-ing dietary supplements with labels that portray the products as an alternative to illegal street drugs such as Ebsta because these products may pose serious health risks to consumers... 

Although the above profusion of in vivo studies evidence their health potentialities, the problem of the bioavailabihty of proanthocyanidins supplied by dietary supplementation has still not been completely resolved since unequivocal evidence for absorption is missing so far [11]. However, studies carried out using radio-labelled procyanidins revealed that dimers and trimers may be absorbed by intestinal cells, whereas a recent study demonstrated that procyanidin oligomers are readily adsorbed in rats [55], while it has been shown that colon microflora may be able to degrade proanthocyanidins to low-molecular-weight aromatic compounds [56]. 

By the year 2010, FDA will have a science-based regulatory program that fully implements the DSHEA. The plan addresses safety, labeling, clarification of the differences between drugs and dietary supplements, and enforcement activities. 

Good manufacturing practices (GMPs) ensure that products meet specific quality standards, are not adulterated or misbranded, and contain the correct ingredients and doses stated on the label. GMPs specifically for dietary supplements are being proposed from the FDA. Cases of adulteration have been reported to the FDA, and examples include a plantain product adulterated with digitalis and hibiscus tea adulterated with warfarin [29]. 

If a pharmacist posted a sign in a pharmacy claiming a dietary supplement is effective in treating or preventing a certain disease, the pharmacist would be violating the FDCA. The product would be considered a drug but not properly labeled as a drug and therefore would be misbranded. 

Recommend products that contain the following on their label scientific name of the botanical, quantity of the herb, name and address of the actual manufacturer, a batch or lot number, date of manufacture, and expiration date. When available, products that are standardized to the active ingredient(s) should be recommended. A common rule of a one-year expiration date on dietary supplements generally applies [5]. 

Unlike with drugs, manufacturers of dietary supplements do not have to disclose potential side effects of their products to consumers. The label of the supplement may contain a cautionary statement, but the lack of such a statement does not mean that no adverse effects are associated with the product. Dietary supplements may also interfere with the activity of other medicines (drugs or other supplements) an individual is taking. Also unlike with drugs, the manufacturer is not required to disclose these interactions to the consumer. 

In February 2004, the FDA withdrew ephedra, one of the most popular dietary supplements, from the market because it finally had enough information to prove that ephedra presented an unreasonable risk of illness or injury under the conditions of use recommended on the product labeling. This withdrawal did not happen until many people suffered from the terrible potential side effects of this supplement (see Chapter 4). 

In accordance with the provisions of the Dietary supplement Health and Education Act 1994, in the United States botanical dosage forms can be marketed as dietary supplements provided the label makes no medical claim however, structure-function claim is allowed. In most countries other than the United States, botanical preparations are regulated as drugs thus posing a different set of challenges. This fact must be taken into consideration in standard setting. 

A Roper survey of 1480 persons age 50 or older, conducted in 2001, found that about 75% of the respondents wanted the government to review safety data and approve dietary supplements before sale and fo verify all health-related claims before they can be included in advertisements and on product labels. This is just contrary to what DSHEA permits, but there is little hope that Congress will modify its provisions. 

Gurley, B.J. et al.. Content versus label claims in ephedra-containing dietary supplements. Am. 

Dietary supplement - 40 to 400 mg/day in divided doses. Refer to product labeling. 

Sales of Ca supplements alone were 875 million in the United States in 2002, and comprised 60% of all mineral supplement sales (Anonymous, 2004). In 2004, sales of Ca supplements increased by 9.3% (Uhland et ah, 2004), possibly to some extent in response to the Surgeon General s report on bone health that was issued that year. More recently in 2006, it was projected that dietary supplement sales in the United States would approach 5 billion (Anonymous, 2006). While Ca derived from a balanced diet is preferable, Ca supplements are a popular noncaloric alternative for increasing daily Ca intake. There are a vast number of oral Ca supplements available in the market place in the form of capsules, tablets, chewable tablets, effervescent tablets, liquids, powders, suspensions, wafers, and granules. However, not all Ca salts are equally soluble or bioavailable and the dose of Ca on the label of a supplement may not necessarily be reflective of the relative amount of available Ca once consumed. Furthermore, the same Ca salt may be more or less bioavailable depending on the production process and materials used to manufacture the supplement. 

A dietary supplement is any product taken by mouth that contains a so-called dietary ingredient and whose label clearly states that it is a dietary supplement. The dietary ingredients in dietary supplements may include vitamins, minerals, herbs, and amino acids as well as substances such as enzymes, organ tissues, metabolites, extracts, or concentrates. Dietary supplements can be... 

Dietary supplements are products taken by mouth that contain an ingredient intended to supplement the diet, such as vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. Dietary supplements come in many forms, including extracts, concentrates, tablets, capsules, gel caps, liquids, and powders. They have special requirements for labeling. In the U.S., the Dietary Supplement Health and Education Act of 1994 states that dietary supplements are considered foods, not drugs. (Note that some dietary supplements are used in conventional medicine for example, folic acid... 

FDA commissioned a study of dietary supplement sales in the United States in 1999. Samples of products were purchased from a representative sample of retail establishments, catalogs, and the Internet. The authors looked at the consistency of botanical products purchased. Forty percent to 46% of botanicals and botanical products were consistent with the ingredients listed on the label. Botanical extracts were even less consistent with the label, only 12%i to 24%i (depending on where purchased) were found to be consistent... 

Drug-Drug, Drug-Dietary Supplement, Drug-Citrus Fruit, and Other Food I nteractions—Label ing I mpl ications... 

Similar to drugs, dietary supplements can make claims to affect the structure or function of the body. However, supplements are specifically prohibited from making disease claims. A dietary supplement bearing structure or function claims is also required to carry the following disclaimer on the product label The FDA has not evaluated this claim. This product is not intended to diagnose, mitigate, treat, cure or prevent disease (19). 

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