miércoles, 9 de marzo de 2016

Consumer Updates > Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You

Consumer Updates > Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You

Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You

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If you buy imported products marketed as “dietary supplements” and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, watch out. Health fraud scams abound. According to Cariny Nunez, M.P.H., a public health advisor in the Office of Minority Health at the Food and Drug Administration (FDA), health scammers often target advertising to people who prefer to shop at nontraditional places, especially those who have limited English proficiency and limited access to health care services and information.
“These scammers know that ethnic groups who may not speak or read English well, or who hold certain cultural beliefs, can be easy targets,” Nunez says. For example, Native Americans, Latinos, Asians and Africans may have a long tradition of turning to more herbal or so-called “natural” remedies. Many advertisers put the word “natural” somewhere on the package of a product, knowing it inspires trust in certain groups.

“Natural” Does Not Mean “Safe”

But just because a product claims to be natural doesn’t necessarily mean it’s safe, says Gary Coody, R. Ph., FDA’s national health fraud coordinator. Likewise, just because a product claims to be natural does not mean that it’s free of hidden drug ingredients.
Furthermore, these products may also be contaminated or contain potentially harmful chemicals or drug ingredients not listed on the label.
For example, many products that claim to help people lose weight contain hidden and dangerous prescription drug ingredients such as sibutramine. Sibutramine was in Meridia, a formerly FDA-approved drug that was removed from the market in October 2010 because clinical data indicated it posed an increased risk of heart problems and strokes.
And just because an ingredient is contained in an FDA-approved drug product does not mean it is safe in the dosages or amounts used in these nonprescription products, according to Coody. Moreover, scammers seek out ethnic populations who are overweight or have serious conditions such as cancer, HIV/AIDS, diabetes, or heart disease. They target consumers looking for easy—and sometimes less expensive—solutions to difficult problems. Using these products could mean delayed treatment for serious diseases.
Others illegally sell imported antibiotics without a prescription and with no physician oversight. According to Coody, this can easily lead to misuse and overuse, a key factor contributing to antibiotic resistance, meaning they might not be as effective in stopping infections when they’re truly needed. And some products marketed as dietary supplements resemble antibiotic products marketed in foreign countries—but actually don’t contain any antibiotics.
You may see these products advertised in ethnic newspapers, magazines, online, infomercials on radio and TV stations or in ethnic stores, flea markets, and swap meets, which may stock products claiming to be from, for example, Latin America or Asia.
“It’s not surprising that people are more comfortable with familiar products that claim to come from their home country or are labeled and marketed in the consumer’s native language, whether they buy them at a U.S. market or get them from friends and family who have brought them from home,” Nunez says.
But that does not guarantee the product is safe or effective.
By the same token, products with the claim “Made in the USA” may not be made here. Consumers sometimes see this claim as an assurance of safety, Coody says, but any scammer can slap the label on, and buyers are none the wiser.
In fact, the law does not require companies who make dietary supplements to get FDA approval before marketing their products.
“Remember, dietary supplements are not drugs,” Coody says. “They are not substitutes for the drugs your health care professional prescribes. And you should let your health care professional know what supplements you are taking, because they may interact in a harmful way with prescribed medications or keep a prescribed drug from working.”
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Watch out for claims like these, which are often used to sell non-prescription health products. You can’t always trust what you read on the label or package—even if it is in a language you know. For more information about these products, visit:

How Do You Know It’s Fraudulent?

Watch out for these claims:
  • One product does it all. Be suspicious of products that claim to cure a wide range of diseases.
  • Personal testimonials. Success stories such as “It cured my diabetes,” or “My tumors are gone,” are easy to make up and are not a substitution for scientific evidence.
  • Quick fixes. Few diseases or conditions can be treated quickly, even with legitimate products. Beware of language such as “lose 30 pounds in 30 days,” or “eliminates skin cancer in days.”
  • “All natural.” Some plants found in nature can kill if you eat them. Plus, FDA has found products promoted as “all natural” that contain hidden and dangerously high doses of prescription drug ingredients.
  • Miracle cure. Alarms should go off when you see this claim or others like it such as “new discovery” or “scientific breakthrough.” A real cure for a serious disease would be all over the media and prescribed by doctors—not buried in print ads, TV infomercials, or on Internet sites.
  • FDA-Approved. Domestic or imported dietary supplements are not approved by FDA.
Finally, if you're tempted to buy an unproven product or one with questionable claims, check with your doctor or other health care professional first. You can also check FDA’s website to see if the agency has already taken action on it.

Have a Bad Reaction? FDA Wants to Hear From You

Suppose you or someone in your family uses a product and has a bad reaction to it. That’s something FDA wants to know about so it can investigate and, if the product is found to be harmful, make sure appropriate action is taken.
You can report a bad reaction or a product defect by calling the Consumer Complaint Coordinator in your state. Or you can report online at FDA’s MedWatch. Your report will remain confidential.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Updated: March 4, 2016

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