Posted on 04/05/2009 7:26:39 AM PDT by neverdem
The days when the dietary supplements industry is allowed to regulate itself may be numbered following release of a federal report addressing growing concerns about dietary supplement industry.
The report, issued this month by the Government Accountability Office, calls on the Food and Drug Administration to expand adverse event reporting and increase its efforts to educate the public about the safety, efficacy, and labeling of these products. The GAO investigation into supplement safety was made at the request of Congress.
According to the 77-page report, the FDA should be tracking all levels of adverse events related to the use of dietary supplements and herbs, not just severe events. And, the report noted, despite the 2007 requirement for improved manufacturing practices, the FDA still lacks even the most basic ability to track the quality of dietary supplements (www.gao.gov/new.items/d09250.pdf).
Companies that manufacture the products are not required to identify themselves as such, or to provide the FDA with information about the products, including the product name and ingredients, the report said. And if a product is found to be dangerous, the agency is hamstrung—it can only ask for a voluntary recall as it did in December, when Star Caps, a popular weight-loss supplement, was found to contain prescription-strength levels of the diuretic bumetanide.
The FDA lost its authority to regulate the ingredients of dietary supplements prior to marketing with the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) (www.cfsan.fda.gov/∼dms/dietsupp.html). Prior to passage of the DSHEA, which went a long way toward deregulating the dietary supplement industry, the ingredients of dietary supplements were regulated under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act.
Dietary supplements fall within the definition of complementary and alternative medicine (CAM). An earlier federal report issued by the Centers for Disease Control and Prevention found that use of CAM is widespread. For example, when patients with arthritis become frustrated by lack of pain relief, they often turn to dietary supplements.
The issue of quality control has bothered Dr. Roy Altman for years. Supplements and herbal preparations designed to promote joint health and relieve pain are some of the most popular products on the market, grabbing almost as big a market share as weight-loss products, he said in an interview. “We are looking at probably $40-$60 billion spent on over-the-counter arthritis supplements each year,” he said, but noted that “this is only a fraction of what is spent on prescribed arthritis medications.”
Some of these products probably do have a beneficial effect in patients with rheumatic disorders, said Dr. Altman, professor of rheumatology at the University of California, Los Angeles. The problem is identifying which products actually contain what the label promises, and nothing else. “We, and a group of colleagues from Canada, once tested 10 different glucosamine products sold in the U.S. Four of them didn't even have glucosamine in them, and of the remaining six, four had much less than was stated on the product label.”
Similar quality control problems led Congress to request the investigation about 18 months ago, said Lisa Shames, the GAO's director of Food Safety and Agriculture Issues. “There has been a lot of congressional interest into how FDA was implementing the requirements [for oversight of dietary supplements and herbal products], especially the requirement for reporting adverse events,” she said in an interview.
One of the paper's key findings is that adverse events are probably significantly underreported, she said. In December 2007, the FDA began requiring manufacturers of dietary supplements and herbal preparations to report all serious adverse events related to the use of their products. “Since then, FDA has had a threefold increase in the number of events reported, but the big question is whether this is all the events that are happening,” Ms. Shames said. From January through October 2008, the FDA received 948 reports of adverse events, compared with 298 over the same time frame in 2007. “FDA recently estimated that the true number of adverse events could be well over 50,000 each year. We recommended that the FDA require reporting of all adverse events, regardless of their severity.”
The report also called on the FDA to require more information from manufacturers about the ingredients in their products.
Also, under current law, manufacturers are the ones to decide whether an ingredient is “generally recognized as safe,” and thus exempt from the laws that govern pharmaceutical products, she said. The report asks that the FDA take part in this responsibility, by clarifying the evidence needed to document an ingredient's safety and the methodology necessary to establish that safety.
The agency should also increase its efforts to educate the public about the safety of supplements, the report concluded. “People think all these products are safe and approved by the FDA, and of course, this isn't the case,” Ms. Shames said.
The report didn't even touch on manufacturing issues, which are controlled by a set of laws that until recently left manufacturing oversight to the companies, with little government regulation. In 2007, the FDA finalized its Good Manufacturing Practice regulations, which will require quality control measures for all domestic manufacturers and foreign manufacturers that distribute in the United States. But the law is being phased in by company size, with the smallest companies having until June 2010 to come into full compliance.
Dr. Altman noted that country of manufacture is not a good guideline. “You might think you are better off buying something that was made in the U.S., but in reality a lot of those are manufactured in China and then repackaged in the U.S.”
Dr. David Riley, founder of the Integrative Medicine Institute in Santa Fe, N.M., pointed to a study in which researchers obtained 190 Ayurvedic medicines from China and India through Internet sources and determined their components by x-ray fluorescence spectroscopy. They found that 20% contained some level of toxic metal (lead, mercury, or arsenic). U.S.-manufactured products were just as likely to be contaminated as were those made in India (22% vs. 19%). Among companies manufacturing the metal-containing products, 75% claimed that they adhered to the FDA's Good Manufacturing Practices (JAMA 2008;300:915-23).
Look who was in charge when this happened — Clinton and the Democrats in Congress. How much money did they take in from the dietary supplement people to get the law repealed?
If they mess with my Chinese herbal doc, I’m gonna be really pi$$ed! I had to use a cane for five years. Two of his mixed bags of herbs, and I’ve been cane and pain free for 8 years!
Yet another shakedown attempt by the Federal government. I don’t believe they are doing this or anything to protect the American people.
When it comes to government...follow the money. Calls for FDA to regulate are about power and money, not protecting people.
If it were about protecting people would the FDA allow RU 486 to be dispensed?
But now obama is president. I see where this is going. We need more regulation. Deem all vitamins and supplements as controlled substances. Only gov’t and powerful pharmaceutical companies should handle this stuff. Only they should be allowed to grow carrots. It will be a felony to be caught growing vegetables in your backyard. And add taxes on taxes to those who “use” supplements.
I agree with you 100% — more regulation and taxes.
Let’s see, Obama is making it harder to make money and harder to be poor. Are we all supposed to sign up for welfare?
“Deem all vitamins and supplements as controlled substances. Only gov’t and powerful pharmaceutical companies should handle this stuff. Only they should be allowed to grow carrots. It will be a felony to be caught growing vegetables in your backyard. And add taxes on taxes to those who “use” supplements.”
They’re just trying to bring us in line with the EU. If you want to see where we’re going just watch the laws passed in Brussels.
OH MY GOD! You mean people are permitted to take Vitamin C without proper governmental controls?? Why, good health could become RAMPANT!
Seems to be the operating theory of the FDA these days.
Er... Just a side note: Where in the Constitution does it give the FedGov the power to run an Agency like the FDA?
Where's that "There was no one else left when they came for me..." poem?
No one spoke up when they came for the Dopers.
No one spoke up when they came for the Juicers.
No one spoke up when they came for the rest of the Supplement industry.
No one is going to come to your aid now that they want your vitamins too...
Not so far fetched, virgil. In Cuba if you grow two carrots and sell one to a neighbor, it IS a felony. All carrots belong to Castro/the collective. Even mini-capitalism lands you in jail.
I’ve been a huge user of supplements for decades and for a few years worked as a health writer, including inhouse stints at a couple of large manufacturers. That was a long time ago, and the big companies were very very careful to label properly, maintain manufacturing standards, and to never print a misleading word in their catalogs/ads. An FDA inspector told me she’d found horrible unsanitary conditions at some small companies and did what she could to get them fixed and/or put them out of business.
But now...I worry a lot about what’s going into my pills and potions. Why? Because virtually everything in the health food store is made in China. My expensive whey protein was once labeled, “Made from Wisconsin milk.” Now it’s only “Distributed by” an American company. With the Chinese so careless about dry milk products, I may be forced to turn to ukky soy. Of course with soy, you need organic non-genetically modified soy and who can trust the labels? Could be all soy milk comes from China too. (Milk from cows makes me barf, even smelling it.)
I’d welcome FDA oversight again, if it protected us from dirty products and dishonest manufacturing. What we decide to ingest had darned well better be our own choice though.
TROUBLE: The UN Codex AliCodex Alimentarius is a trade Commission under the control of the United Nations/World Trade Organization that intends to make all therapeutic dosages of vitamins, herbs and other supplements illegal by December 31, 2009. They claim this action is being taken to protect the public from toxic substances.
In other words, The UN wants to make us all as unhealthy as African hut dwellers.
In other words, they are taken solely on the basis of the person's choice and that choice on the basis of their own research about the 'supplement'.
They need no regulation, but, prior to use people DO need to do more research and long-term personal experience of friends and acquaintances are a helpful guide.
Like all chemical substances, from nature or from a pharmaceutical laboratory, the actual experience of individuals and the affects of long term use not only vary from individual to individual but widely demonstrate there are few guarantees about such affects, even with FDA approved, physician prescribed, pharmaceutical lab produced substances.
There are as many cases of valuable, sometimes life-saving substances being kept off the 'FDA approved' market, due to the labyrinth of laws, regulations, testing and approvals involved in obtaining an O.K. from the FDA, as there are incidents of ill-affects of the use of 'supplements'. The FDA process is no guarantee that the best products are the 'legal' products or that the 'legal' products are inherently safer - TO THE INFORMED CONSUMER, WHETHER USING AN FDA APPROVED DRUG OR A SUPPLEMENT.
Thiazolidinedione Use Linked to Increased Fracture Risk (Actos & Avandia)
HbA1c May Soon Be Top Diabetes Diagnostic Test
FReepmail me if you want on or off my health and science ping list.
Pretty soon, you’ll need a scrip for Vitamin C.
But a fifteen year old girl will still be able to walk in a pharmacy and get the morning after pill without any questions whatsoever...
And then there’s the UN’s Codex Alimentarius that’s looming over us. Lots of info online. Here’s a short description written by Sue McIntosh, M.D, a retired pediatric oncologist.
Posted by mcintosh.sue on Feb 17 2009,
“The Codex Alimentarius is a CORPORATE list of ALL substances which will be legal to put in our mouths after it is implemented in the U.S. on 12/31/09.
” All vitamins, supplements, organic foods, clean water, raw milk, etc., will be ILLEGAL in the U.S. and in the North American Union (planned fusion of U.S. with Canada and Mexico) after the end of this calendar year.
“This is why the news media is trying to terrify Americans about food—the recent peanut butter-Salmonella thing, the spinach and tomato things last year, and more to come. “They” are laying the groundwork to implement radiation of ALL FOOD sold in the U.S.—”problem-reaction-solution.”
“This is why, all of a sudden, vitamins and minerals “do nothing” for you.
“This is the face of the New World Order (NWO), folks, and we need to do everything in our power to upset their plans and say a fierce, loud, NO! to the Codex Alimentarius. What you read or hear about it tries to sell it as a “food safety” measure. What they are really doing is trying to wipe out all natural food stores, organic food sources, all vitamins/minerals/supplements not currently made by the pharmaceutical industry so that the industry can take over the manufacture and sale of all these things. As usual, it’s all about profits for the rich.”
End of mcintosh quote. One thing she failed to mention is that Codex has been funded for decades by by Bayer, the German BigPharma mfg of aspirin and a whole lot more. If products in health food stores are outlawed, they can sell them as prescriptions. (Imagine Vitamin C for $100 for a month’s supply.)
In ‘85, I met a department head from Lilly in Germany. He was there buying up homeopathic formulas. So those little tabs I used to get for $4 that never failed to cure a cold will soon be $44, and probably require a prescription. Or just disappear, which I think happened because...they’ve disappeared.
More on Codex Alimentarius with links at #1:
The UN/WTO Codex criminalizes vitamins, supplements and herbs
http://www.freerepublic.com/focus/f-news/1353912/posts
With Ibn al’0bama so cozy with the UN, I believe we are in grave danger of losing our rights to nutritional standards somewhat higher than those who live in Third World huts.
Just another way he can hurt us. Bring America to her knees by making Americans financially and physically weak. The genuflection he made to King Saud said it all.
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