And I will say it again, and again, and again...stay away from
"supplements"!! Last week "Craze" a popular supplement sold online,
Wal Mart, GNC, etc. suspended sales after traces of amphetamine
were found in the product. Here's another way to look at this
published: August 19, 2013 7:48 PM
August 23, 2013 3:26 PM
About 70 percent of the nation's supplement companies have run
afoul of the U.S. Food and Drug Administration's manufacturing
regulations over the past five years, according to a top agency
Consumers are put at risk by poorly measured ingredients, uncleaned
manufacturing equipment, pesticides in herbal products, supplements
contaminated with illegal prescription medications -- even bacteria
in pediatric vitamins, recall notices and agency inspection records
"We're seeing some real problems out there," said Dr. Daniel
Fabricant, who heads the FDA's division of Dietary Supplement
Programs, referring to manufacturing issues affecting a large
number of dietary supplement companies.
He said many companies don't even have basic recipes for the
vitamins and other supplements they sell.
While most vitamins and supplements are not harmful -- and at least
one vitamin brand was credited with an 8 percent reduction in
cancer among men over 50 -- the industry is beset by repeated
recalls, manufacturing problems and adverse reactions caused by
tainted products, health experts and regulatory officials say. And
there is little the FDA can do to improve the situation, Fabricant
said, unless Congress legislates more regulatory authority for the
Roughly half the U.S. population -- 150 million people -- consumes
multivitamins, mineral tablets, weight-loss aids, herbal remedies,
protein powders and a host of other products that fall under the
vast rubric of dietary supplements.
Supplements, a $28 billion industry made up of about 450 U.S.
companies, are deemed "food" by law and are not subject to the
tough regulatory scrutiny of prescription drugs.
Mira Health Products in Farmingdale, which has had a clean FDA
compliance record according to the agency, is under investigation
because vitamins it manufactured were laced with anabolic steroids,
FDA and state Health Department testing revealed.
The illegal compounds are sometimes used by bodybuilders to
increase muscle mass.
Long Island firms eyed
Acting as a contract lab, Mira produced B vitamins, multimineral
tablets and vitamin C supplements for another Long Island firm,
Purity First Health Ltd. Purity, once located in Farmingdale, now
is run out of an East Northport house.
Owner Candice Tripp said she hasn't had a problem in 23 years of
selling vitamins. Mira's lawyer said the company is cooperating
"We are answering the FDA's questions and responding to queries
about manufacturing processes at the company," said lawyer Marc
Ullman of Garden City.
The process, he noted, could take weeks.
Sixteen nationwide recalls and warnings have been issued in the
past month and a half, including vitamins manufactured by Mira,
which contained the risky steroids dimethazine,
dimethyltestosterone and methasterone. More than 3,000 products
were recalled nationwide last year.
Written product recipes at numerous supplement companies are
nonexistent, Fabricant said, and many recipes -- known as master
manufacturing records -- are apparently cobbled together when
owners learn that government inspectors are on their way.
Worse, drums in which products are mixed are not always
appropriately cleaned, Fabricant added, and in some firms these
vessels are pitted -- damaged -- possibly from age and/or overuse.
Debris left from previous batches sometimes winds up in newly made
products, he said.
Too often, dangerous drugs of all kinds -- from male sexual
enhancement compounds to weight-loss medications -- are turning up
in vitamins and other supplements nationwide.
A report in the Journal of the American Medical Association in
April noted that potent drugs are sometimes purposely added to
supplements to increase strength, usually weight loss remedies and
Sibutramine, for example, which is now banned, causes weight loss
but also can lead to heart attack or stroke.
Consumers also are put at risk, Fabricant said, by raw products
from foreign sources. Most of what he calls "the alphabet vitamins"
-- A, B, C, D and E -- have provenance in China. The same is true
of botanicals, Fabricant said, some of which are found to be
tainted with pesticides.
Pervasive pesticide usage abroad, he said, raises questions about
the safety of so-called health products sold here.
"What we're finding is that people [manufacturers] are not testing
their products," Fabricant said.
Whether Mira's situation involves tainted raw materials from abroad
or drums that had been used to mix other products has yet to be
determined. No one knows how the steroids found their way into
The multitude of manufacturing lapses facing the industry,
Fabricant and other experts say, constitutes a breach of the public
Examples of that breach include:
A New Jersey family in 2011 receiving federal prison sentences and
orders to pay fines totaling more than $1 million for the rodent
infestation and filth at their protein powder enterprises. Rodent
feces and urine were found in a product blending area and a rodent
that had been chopped in half was found on a blender platform,
according to an FDA report.
In April of this year, a Texas distributor of the weight loss
supplements OxyElite Pro and Jack3D agreed to stop lacing their
products with the stimulant dimethylamylamine -- DMAA. At least one
U.S. death has been linked to the Jack3D supplement. The FDA first
warned the distributor last year. Under federal pressure, the
company destroyed its entire stock last month, worth about $8.5
million, according to the FDA.
Also this year, an analysis at the Kaiser Permanente Center for
Health Research in Oregon found that several brands of vitamin D
pills didn't contain the amount of active vitamin indicated on the
Sickened by supplements
Consumers, meanwhile, continue to be sickened by their supplements.
Approximately 6,300 people nationwide complained about adverse
reactions to dietary supplements between 2008 and 2012, according
to FDA statistics. But the actual number may be more than eight
times higher, some experts say, because most people don't believe
health products can make them sick.
An estimated 51 percent of the FDA's recalls of dangerous products
that can cause serious health problems or death involved tainted
vitamins and other supplements, according to a report in an April
edition of the Journal of the American Medical Association.
Twenty-nine confirmed sickenings have been linked to Purity's
vitamins, 20 of which were diagnosed at North Shore University
Hospital in Manhasset by Dr. Ken Spaeth, who was the first to link
symptoms in the patients to anabolic steroids. The one common
thread tying one patient to the others was having been treated by a
Farmingdale chiropractor and the Purity vitamins that were
An additional 10 cases are under investigation.
Teresa Cantwell, 55, of Rockville Centre, said she and her
27-year-old daughter are still recovering after taking vitamins by
Purity for nearly a year. Both lost hair and developed deeper
voices, a direct consequence of anabolic steroid exposure, they
were told by their doctors. Cantwell said her daughter's liver
enzymes rose and her menstrual periods stopped.
"We were essentially poisoned," Cantwell said, adding that a
four-month vitamin supply for just herself cost her more than $500.
Cantwell said her chiropractor, Terence Dulin of Farmingdale,
recommended that she buy the vitamins from Tripp and take them
"morning, noon and night" to achieve a robust state of health.
She said she had hoped to lower her moderately high cholesterol
level without having to take medication. Instead, it rose above
300, a side effect of the steroids in the vitamins, she said she
was told by her doctors.
Tripp told Newsday the government is trying to run small vitamin
makers out of business.
She said that if people are sick on Long Island, it's because of
exposure to pesticides washed to the surface by superstorm Sandy.
Dulin has not returned Newsday's email inquiry. His phone has been
out of order for nearly a month.
FDA's limited power
The FDA began inspecting how vitamins and other dietary supplements
are manufactured only in 2008. And there is little the FDA can do
to exercise more power over supplement safety without an act of
Congress, Fabricant said.
U.S. Senate lawmakers reintroduced a measure this month to grant
the agency more power. The bill was initially introduced in 2011.
Cara Welch, senior vice president of scientific and regulatory
affairs for the Natural Products Association, a trade group in
Washington, D.C., noted "the industry is trying to comply with the
FDA's GMP requirements," she said of good manufacturing practice
"This is an industry with a relatively new regulatory framework,"
she said, referring to inspections.
Dr. Arthur Grollman, a professor at Stony Brook University School
of Medicine -- and one of the nation's most vocal advocates for
tightening regulations in the supplement industry -- said the 1994
Dietary Supplement Health and Education Act has hamstrung the FDA.
Authored in 1993 by Sen. Orrin Hatch (R-Utah) and strongly
supported by the supplement industry, the law allows the industry
to regulate itself. And much of the industry, Grollman noted, is in
"I am not saying to abolish DSHEA," Grollman said. "I am saying it
should be amended."
RECENT WARNINGS AND RECALLS
More than 9,700 recalls of dietary supplements were requested by
the FDA between 2008 and 2012. Slightly more than 6,000 adverse
reactions were reported, which included minor problems, serious
injuries and deaths. Here is a list of recent warnings, recalls and
July 19 Recall of Herbal Give Care LLC's weight loss and
vitamin supplements. The products contain sibutramine, which is
banned for heart attack risks, and two derivatives.
July 24 USPLabs destroys $8.5 million worth of weight loss
supplements, Jack3D and OxyElite Pro. The products contained the
dangerous heart stimulant, DMAA.
July 26 Recall of vitamin B-50 supplement distributed by
Purity First Health Products. The supplements contained anabolic
July 31 Recall of Purity First products expanded to
include multi-mineral and vitamin C.
Aug. 3 Recall of weight loss supplement made by CTV Best
Group because it contains sibutramine.
Aug. 5 Recall for for weight loss supplements made by
Bethel Nutritional Consulting. The supplements contain sibutramine
and phenolphthalein, which is a laxative and possible carcinogen.
Aug. 8 Recall expanded for weight loss supplements made by
Bethel Nutritional Consulting.
Aug. 8 Recall of sleep aid made by Health and Beyond LLC.
The supplement contains doxepin, a prescription sleep medication
and chlorpromazine, a drug for psychotic disorders.
Aug. 16 Multiple warning letters issued to makers of
energy, sleep aid and vitamin D products for manufacturing