Nature's Way has been fined and cited for fraud several times by the Federal Trade Commission.
Considering the INCREDIBLY broad leeway that supplements have, you almost have to TRY to get spanked by the FTC.
And one of their products was deemed "unsafe" by the FDA.
Again, with supplements you almost have to TRY to get pulled off the market.
The research was financed by the company that markets the extract.
<snip>
The extract used in the German trial is marketed in European countries under the brand name Neuroplant VO, said Dr. Jochen Muehlhoff, marketing information manager for the company. It is sold in the United States as a dietary supplement by
Nature's Way products under the brand name Perika, "for promoting a positive mood, rather than a drug for the treatment of depression," he said.
More:
http://story.news.yahoo.com/news?tmpl=story&cid=97&ncid=97&e=6&u=/hsn/20050211/hl_hsn/herbaltreatmentoutdoespaxilSee also:
The cabbage soup diet recipe site explains that Answers 03/18/1992 FDA ORDERS NATURE'S WAY GUAR GUM DIET PILLS OFF MARKET T92-14 Sharon Snider March 18, 1992 (301) 443-3285 FDA ORDERS NATURE'S WAY GUAR GUM DIET PILLS OFF MARKET FDA has received numerous inquiries about action taken recently by 10 states and the FDA against diet drug products containing guar gum. The following may help in responding to questions. In a nationally coordinated effort, FDA and 10 states moved to stop the sale of a weight control drug product containing guar gum, an ingredient determined by FDA to be unsafe for weight control. FDA warned Nature's Way Products, Inc., of Springville, Utah, to stop distributing its East Indian Guar Gum capsules and to remove them from the market immediately. Acting in concert with FDA, attorneys general in 10 states ordered General Nutrition Centers, the major distributor of the capsules nationwide, to stop selling them. They also ordered General Nutrition Centers to recall and destroy all other diet products containing guar gum. Failure to do so could result in civil penalties. The nationally coordinated action by FDA and the state attorneys general is the first of what are expected to be more joint enforcement actions against health fraud, deceptive practices and other violations of federal and state food and drug laws. FDA banned the use of guar gum in nonprescription diet drug products after numerous reports that the ingredient presents a health hazard. The -MORE- Page 2, T92-14, Guar Gum agency also banned 110 other weight control ingredients in these products because none had proven effective. Guar gum was found to be neither safe nor effective. Guar gum is a complex sugar that swells when it becomes wet and is purported to create a sense of fullness when ingested. Diet drug products containing guar gum have caused numerous cases of esophageal, gastric and intestinal obstruction.
Many people affected required hospitalization, and one eventually died as an indirect result of esophageal obstruction. Although the ingredient is banned in weight loss drug products, it is approved for use in small amounts in foods such as cheese, salad dressings and ice creams. This use is not a health concern. In a letter to Nature's Way, FDA cited both use of a banned ingredient and claims on the label that make the product a new drug, requiring FDA approval before it can be legally marketed. East Indian Guar Gum capsules claim to promote weight control, regularity and digestion, and to control glucose and reduce cholesterol. Marketing a new drug without FDA approval is a violation of the Federal Food, Drug, and Cosmetic Act. FDA gave Nature's Way five days to advise the agency how it plans to comply with the law. Failure to do so could result in further regulatory action, such as seizure or injunction. FDA has moved against 14 manufacturers of guar gum diet drug products in the past couple of years. In July 1990, the agency told the marketer of Cal-Ban 3000 diet tablets and capsules to stop distributing those products and ordered distributors to recall supplies.
U.S. Marshals subsequently seized more than 350,000 bottles of Cal-Ban 3000. In September 1991, a federal judge condemned the seized Cal-Ban 3000 as an unapproved new drug and ordered it destroyed.More:
http://www.thejacastaproject.co.uk/natural-pain-killer.htmlhttp://www.fda.gov/bbs/topics/ANSWERS/ANS00386.htmlSee also:
http://www.ftc.gov/opa/predawn/F93/cantrol.htmFOR IMMEDIATE RELEASE: January 26, 1990
FTC CHARGES NATURE'S WAY PRODUCTS' ADS FOR "CANTROL"
WERE FALSE AND UNSUBSTANTIATED; COMPANY TO PAY
$30,000 FOR MEDICAL RESEARCH, UNDER CONSENT AGREEMENT
The Federal Trade Commission has charged Nature's Way Products
with making unsubstantiated claims in advertising that "Cantrol"
capsules fight yeast infections. Under a consent agreement
announced today for public comment, the company agreed not to make
unsubstantiated claims about certain nutritional supplements in the
future and also agreed to pay $30,000 to the National Institutes
of Health to support research in candidiasis or the effects of
yeast on health.
The complaint charges that the company advertised Cantrol with
a 14-question, diagnostic "yeast test," with such questions as "Do
you feel tired most of the time?" and "Do you suffer from swing
moods or depression?" The ad claimed that "If you answered 6 or
more questions with a 'yes,' the probability is high to very high
that you, like so many others, have a yeast infection." These ads
were carried in national magazines such as American Health, Shape,
and Let's Live.
The ads claimed that yeast (candida albicans) "can sometimes
grow rapidly due to a variety of conditions," but that "Cantrol's
high potency formula helps keep yeast colonies from overpopulating
in the intestines where they grow."
The complaint charges that the "yeast test" does not demon-
strate that a person is likely to have a yeast infection. It also
charges that Nature's Way did not have a reasonable basis for its
claim that consumption of Cantrol controls adverse effects on
health commonly caused by excessive levels of yeast in the intes-
tines and controls vaginal yeast infections.
Under the consent agreement, Nature's Way agreed not to
misrepresent, in advertising for any food supplements, any self-
diagnostic test concerning yeast conditions. In addition, the
company must not make any representation concerning any food
supplement's ability to control yeast conditions, unless it can
substantiate the claim. It also agreed not to represent that
Cantrol or any other food supplement containing certain ingredients
can cure, treat, prevent, or reduce the risk of developing any
disease, unless the company can substantiate the representation.
Those ingredients are acidophilus, Evening Primrose Oil (EPO), Pau
D'Arco, linseed oil, caprylic acid and vitamin E.
In lieu of redress, Nature's Way agreed to pay $30,000 to the
National Institutes of Health, to fund research into yeast condi-
tions.
The complaint and agreement name Nature's Way Products Inc.,
its management company Murdock International Corp., and Kenneth
Murdock, the president of both companies. They are all based in
Springville, Utah.
The Commission vote to accept the consent agreement for public
comment was 4-1, with Commissioner Andrew J. Strenio, Jr., dissent-
ing. In a separate statement, Strenio said that, "Since the prima
facie case is so strong and involves public health considerations,
the Commission should not settle for so little." He said that he
felt the injunctive relief requiring substantiation for any disease
prevention claims should cover all dietary, food, or nutritional
supplements rather than be limited to the ingredients found in
Cantrol. He also indicated that the $30,000 payment to NIH was too
low, saying "consumer spending for Cantrol purchases during the
time in question was roughly $6,000,000. Thus, although the
$30,000 figure might have been tolerable if taken together with
sweetened injunctive relief, the public ought not be forced to
swallow it here."
The consent agreement will appear in the Federal Register and
be subject to public comment for 60 days, after which the
Commission will decide whether to make it final.
Comments should be addressed to the Office of the Secretary,
FTC, 6th St. and Pennsylvania Ave. N.W., Washington, D.C. 20580.
A consent agreement is for settlement purposes only and does
not constitute admission of a law violation. When the Commission
issues a consent order on a final basis, it carries the force of
law with respect to future actions. Each violation of such an
order may result in a civil penalty of up to $10,000.
Copies of the agreement, the complaint, and an analysis of
the agreement are available from the FTC's Public Reference Branch,
Room 130, 6th St. and Pennsylvania Ave. N.W., Washington, D.C.
20580; 202-326-2222; TTY 1-866-653-4261.
# # #
MEDIA CONTACT: Susan Ticknor, Office of Public Affairs,
202-326-2181
STAFF CONTACT: Robert C. Cheek, Bureau of Consumer Protection,
202-326-3045
(File No. 862 3073)
(Cantrol)
See also:
www.ftc.gov/os/closings/staff/natureswayclose.htm