Beware Hoodia Gordonii diet pill spam scamJanuary 30, 2006
The spam ads that fill your mailbox promise a miracle in a single pill -- an appetite suppressant that makes dieting a snap by killing your desire to eat.
Interest in the plant skyrocketed after a rumor began to circulate that hoodia is the diet drug of choice for the "Desperate Housewives." But popularity aside, experts say proof that hoodia works is anecdotal, that little research has been done to confirm the assumption it has no side effects, and that consumers who are buying the supplements over the Internet may not be getting what they're paying for.
Hoodia cacti are native to the semi-deserts of South Africa, Botswana, Namibia and Angola. There are about 20 species in this family but the gordonii is the one that contains a natural appetite suppressant. It thrives in extremely high temperatures, and takes years to mature.
Hoodia gordonii is very rare and is protected by national conservation laws in South Africa and Namibia. The South African government has limited the export and farming of Hoodia to prevent over-exploitation, and have banned wild harvesting of the hoodia plant. In October, 2004, CITES (Convention on International Trade in Endangered Species of Wild Fauna and Flora) provided added protection. Hoodia gordonii cannot be exported as a weight loss product. Limited amounts of the plant can be exported, but only as herbarium collections.
Scientists have found that one molecule in the plant is responsible for the appetite reducing effect. This molecule has been named P57. Phytopharm owns the patent to P57, and no other company or individual can sell hoodia as a weight loss aid.
Pharmaceutical giant Pfizer entered a deal with Phytopharm and tried to isolate P57 into a form that could be marketed to the public. After several years of research, they determined that this was not possible, and they pulled out of the agreement.
"Pfizer released the rights to the primary ingredient," says Paul Hutson, Associate Professor in the UW-Madison School of Pharmacy. "For Pfizer to release something dealing with obesity suggests to me that they felt there was no merit to its oral use."
Hoodia is currently being sold online by various companies and individuals. They are selling dried, powdered hoodia. However, the appetite suppressing ability of hoodia gordonii is only found in large fresh pieces of the plant.
Some people have questioned whether products boasting of hoodia actually contain the supplement. Critics have argued that there isn't enough cultivated hoodia to account for all the products claiming to have it. These plants are very difficult to grow and need a lot of attention and control of watering, temperature and sunlight.
"Hoodia has not been allowed as an ingredient in the United States," says Cheryl Myers, director of health sciences at Enzymatic Therapy Inc.--a Food and Drug Administration-registered pharmaceutical dietary-supplement company based in Green Bay. "It is not technically legal to import it as a dietary supplement. There was some company that was working with Anna Nicole Smith (*) that was trying to market hoodia and they got slapped by the FDA(**)."
(*) Anna Nicole Smith, former Playboy Playmate of the Year and dubious cultural icon, who shilled for a hoodia-based pill called TrimSpa.
Before buying a hoodia supplement, remember that "some of it doesn't have any hoodia in it at all," says Myers.
Nutritionists say even if the supplement works, it might be better if it didn't. Dieting by starving the body is not a good idea, says Pam Wilson, chief clinical dietitian at San Ramon Regional Medical Center.
When the body is starved, the metabolism slows and any calories it gets are stored as fat.
"It can lower our metabolism by 30%," Wilson says. "That's not what you want to do if you're trying to lose weight."
"What's the point in starving yourself or going on a fad diet?" Wilson asks. "People who do that lose weight quickly, but studies show that most gain back the weight in a year, and 100 percent gain it back in five years."
Wilson has other concerns about the supplement. The only known clinical study was conducted on rats, and because hoodia is considered an appetite suppressant that affects the body centrally, there are unknown risks to organs, nervous and circulatory systems.
That's often a problem with herbs and supplements. The products are not tested and regulated in the same way that prescription medications are. A product may be on the market a long time before a pattern of trouble is revealed. There is a history of weight-loss products that were initially considered benign -- fen-phen, ephedra -- and later were discovered to cause serious health problems, some of which resulted in deaths.
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Warning Letter for Weight Loss Products
"TrimSpa Carb Blocker" and "TrimSpa Fat Blocker"
Food and Drug Administration
5100 Paint Branch Parkway
College Park, Maryland 20740
RETURN RECEIPT REQUESTED
17360 Colima Road, Suite 248
Rowland Heights, CA 91748
Dear Sir or Madam:
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.vitamaker.com and has concluded that claims on this web site cause your products "TrimSpa Carb Blocker" and "TrimSpa Fat Blocker" to be misbranded under the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA's regulations through links on FDA's Internet home page: http://www.fda.gov.
Under section 403(r)(6) of the Act, dietary supplement labeling may include claims about the supplement's effect on the structure or function of the human body (structure/function claims), provided that certain requirements are met. 21 U.S.C. § 343(r)(6)(A). One of these requirements is that the manufacturer of a dietary supplement bearing a "structure/function" claim must have substantiation that the claim is truthful and not misleading. 21 U.S.C. § 343(r)(6)(B).
The labeling of "TrimSpa Carb Blocker" and "TrimSpa Fat Blocker" bears structure/function claims, including the following:
TrimSpa Carb Blocker:
"Reduce[s] Absorption of Carbs and Helps Stabalize [sic] Blood Sugar"
"Guaranteed to block the breakdown of carbohydrates and simple sugars from being converted into fat."
TrimSpa Fat Blocker:
"Fat Blocker … can substantially reduce the amount of fat absorbed from the foods you eat."
"The fat molecules from your food bond with TrimSpa Fat Blocker then get eliminated through your digestive tract as waste material."
We have reviewed these claims and have concluded that they are not supported by reliable scientific evidence. Because these claims lack substantiation, they are false or misleading, and cause your products to be misbranded within the meaning of sections 403(a)(1) and 403(r)(6)(B) of the Act. 21 U.S.C. § 343(a)(1), (r)(6)(B). It is a violation of section 301(a) of the Act to introduce or deliver for introduction into interstate commerce any food, including a dietary supplement, that is misbranded. 21 U.S.C. § 331(a).
This letter is not an all-inclusive review of your web site and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products. 21 U.S.C. §§ 332, 334. You should take prompt action to correct any violations, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice.
If you have scientific evidence which you believe substantiates that your claims for "TrimSpa Carb Blocker" and "TrimSpa Fat Blocker" are truthful and not misleading, please provide it to us within fifteen (15) working days of receipt of this letter. Alternatively, please advise this office, in writing and within fifteen working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to ensure that similar violations do not occur in the future. If corrective action cannot be completed with fifteen working days, state the reason for the delay and the time within which the corrections will be made.
Your reply should be sent to the attention of Compliance Officer Quyen Tien at the above address.
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition