*please* check out new law about buying supplements

[Geoff_M]

DisneyBamaFan, I agree... let's chuck the whole deal and go back to the Golden Age of medicine:

(Being located in NJ, I hope you're just yanking my chain, btw.)

 

[N.Bailey]

1. For starters, the FDA has no control over the mislabeling of dietary supplements. Federal labeling laws covering supplements are policed by the FTC under the banner of "false advertising". It's also incorrect that supplement makers are required to disclose every ingredient in their products. They can get busted by the FTC if their label says that it contains something it doesn't (or in the amounts stated), but the opposite isn't necessarily true. Being a "dietary supplement" means that legally their products are treated as a "food item". If what you say is true about the legal requirements to name all ingredients, then to learn ALL of the ingredients of Coke we'd just have to look at the label on a bottle instead of breaking into Coca-Cola's safe in Atlanta!

2. US made dietary supplement labeling is so unreliably incomplete that the IOC has gone to far as to warn all athletes to avoid dietary supplements sold in this country if they don't want to risk their eligibility:

3. I asked for examples to back up your assertion that "you can take it to the bank that your supplements will WAY more than you'll be able to afford" if this bill becomes law. However, seeing as how makers of store brand OTC drugs, who you acknowledge are able to sell their products at significantly less cost than current dietary supplement prices, are able to comply with regulations that require them to disclose their ingredients and they are able to keep their prices very low in the process... this argument doesn't support your assertion.

"Serious adverse drug experience" has a specific legal definition "Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect." The FDA has been collecting adverse event reports of ALL types from dietary supplement users directly since 2007, but legally supplement makers have only been required to report serious events since that time. However, many of them do give the FDA all of their reporting data voluntarily (good for them!). But, there is nothing to legally prevent a supplement maker from sitting on adverse reaction reports from users about less-than-lethal events or events that didn't put them in the hospital on an inpatient basis.

So since all supplement makers should have a pharmacovigilance program (or the equivalent to it) in place now to collect and report the legally required events, and many makers already do report ALL events anyway, then again, there's no evidence in this argument that legally requiring makers to report all events would significantly drive up their costs.

Steroids aren't necessarily the issue here. In many cases the athlete got in trouble because the supplement they were taking wasn't properly labeled as containing banned substances (either a steroid itself or an ingredient that would mask steroid use in doping tests and is therefore banned too). It's also hard for the FDA to pull stuff off the shelf if they don't have any idea exactly what's in it or know that it's on the market because the makers don't have to register the product with them before marketing it.

4. Again, what does this have to do with cost to market? And as with Red Yeast Rice, if the "supplement" contains the active pharmaceutical ingredient of a prescription drug (or an investigative drug in the case of pyridoxamine), you can't sell it over the counter regardless of it's patented or generic.

5. Source please.... and again, what does this have to do with cost to market?

Let's hear some chapter and verse...

I don't have a lot of time here, but let me get thru what I can. I put numbers in your post and will respond with those numbers in mine.

1. I hope the FDA's own site is good enough for your supposed high standard.
What information must the manufacturer disclose on the label of a dietary supplement?

FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.

In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a

"Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.
http://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm

2. The labeling isn't unreliable, it's simply UNENFORCED! The laws are already on the books to deal with these issue and we do NOT need further laws to combat these issues. The authority is ALREADY there.

3. Sorry, I just assumed I was speaking with someone slightly familiar with the process who would know that adding extras to a process would increase costs for said product. Giving carte blanche gives more power and authority over regulating supplements than food products (which you at least can equate that much), and ALSO prescription drugs in some instances. Putting links out to show you how the costs will be time consuming (though there are lots of sites if you actually did research the issue) and right now, I don't have time for that (Lost is on tonight, sorry) right now. If I get time, I will surely dig you up some links however.

As for what's in the product, yes, steroids is what did start the whole process of this new regulation. I don't think there is any denying that there could very likely be illegal substances in supplements. What you fail to understand however is, no further legislation is required to tackle that problem. All that needs to be done is to enforce what's already in place. Since almost every aspect of government is stretches so thin as it is however, it's hard to stay on top of it all.

4. Sorry, I didn't realize you set the standard for everything having to be about cost to market. That's why I thought B6 was fair game (as did others when it came to Red Yeast Rice. Had you typed it into Google however, you'd have come up with a millions links of how it was pulled.

Here is just 1 link. I didn't pick and choose. I am not familar with the site even. It just came up as #1. There are MANY others if this doesn't appease you.

FDA Declares Form of Vitamin B6 a Drug, Effectively Banning Pyridoxamine from Dietary Supplements

The FDA has effectively banned a naturally-occurring form of vitamin B6 called pyridoxamine by declaring it to be a drug, reports the American Association for Health Freedom. Responding to a petition filed by a drug company, the FDA declared pyridoxamine to be “a new drug.”

Now, any nutritional supplements containing pyridoxamine will be considered adulterated and illegal by the FDA, which may raid vitamin companies and seize such products. See the history of FDA raids on vitamin companies here: http://www.naturalnews.com/021791.html

Pyridoxamine occurs naturally in fish, chicken and other foods (http://en.wikipedia.org/wiki/Vitamin_B6), putting the FDA in the strange position of banning a substance from dietary supplements even though it is already present in the food supply.

The FDA’s war on Mother Nature

It’s not the first time the FDA has declared a natural molecule to be a “drug” while attacking nutritional supplements that contain the same molecule. A similar story unfolded with red yeast rice and the lovastatin molecules it contains that lower high cholesterol. The drug companies engaged in biopiracy, ripping off the molecule from red yeast rice to make their now-famous “statin drugs.” Once the statin drugs were patented, Big Pharma and the FDA went after red yeast rice, claiming the supplement was “adulterated with pharmaceuticals.”
http://www.prisonplanet.com/fda-dec...ng-pyridoxamine-from-dietary-supplements.html

Why in the world would big pharma companies want us to be able to buy an inexpensive supplement that is better for us, and more effective? They certainly don't want to let that cash cow go. Now it's a drug, even though it fits the very definition of a supplement by the FDA.

What is a dietary supplement?

Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.
http://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm

5. Again, I don't understand why every question you ask has to do with cost to market. I didn't realize that that was the ONLY topic allowed for discussion. Though it's a HUGE point, IMO, it's not the ONLY point.

Now, as for aspirin, I'll do some more legwork for you since you don't really seem to care about truth.

Maybe you'll enjoy this link? I won't even risk spoiling it by pasting much of it here. I'm just shocked you even needed any links on this subject because it's as 101 as it gets.

http://www.healthsentinel.com/jooml...can-war-casualties&catid=5:original&Itemid=24
The July 1998 issue of The American Journal of Medicine stated the following:

"Conservative calculations estimate that approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone. The figures of all NSAID users would be overwhelming, yet the scope of this problem is generally under-appreciated."

I can assure you, there are MANY, MANY, deaths a year from FDA approved drugs. Now, show how many deaths result from supplements?

Sorry, didn't proof this.

 

[N.Bailey]

I found a couple more links for you. From the Journal from the American Medical Association.

Incidence of Adverse Drug Reactions in Hospitalized Patients

A Meta-analysis of Prospective Studies

Jason Lazarou, MSc; Bruce H. Pomeranz, MD, PhD; Paul N. Corey, PhD

JAMA. 1998;279:1200-1205.

Objective.— To estimate the incidence of serious and fatal adverse drug reactions (ADR) in hospital patients.

Data Sources.— Four electronic databases were searched from 1966 to 1996.

Study Selection.— Of 153, we selected 39 prospective studies from US hospitals.

Data Extraction.— Data extracted independently by 2 investigators were analyzed by a random-effects model. To obtain the overall incidence of ADRs in hospitalized patients, we combined the incidence of ADRs occurring while in the hospital plus the incidence of ADRs causing admission to hospital. We excluded errors in drug administration, noncompliance, overdose, drug abuse, therapeutic failures, and possible ADRs. Serious ADRs were defined as those that required hospitalization, were permanently disabling, or resulted in death.

Data Synthesis.— The overall incidence of serious ADRs was 6.7% (95% confidence interval [CI], 5.2%-8.2%) and of fatal ADRs was 0.32% (95% CI, 0.23%-0.41%) of hospitalized patients. We estimated that in 1994 overall 2216000 (1721000-2711000) hospitalized patients had serious ADRs and 106000 (76000-137000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.

Conclusions.— The incidence of serious and fatal ADRs in US hospitals was found to be extremely high. While our results must be viewed with circumspection because of heterogeneity among studies and small biases in the samples, these data nevertheless suggest that ADRs represent an important clinical issue.

http://jama.ama-assn.org/cgi/content/abstract/279/15/1200

Yeah, the FDA it the sole authority on the subject. NOT!

 

[N.Bailey]

I just loved this and couldn't cut it.


Frequently Asked Questions – Dietary Supplements

What is a dietary supplement?

According to DSHEA, a dietary supplement is any product that contains one or more dietary ingredients such as a vitamin, mineral, herb or other botanical, amino acid or other ingredient used to supplement the diet. Dietary supplements are not food additives (such as saccharin) or drugs.

Are dietary supplements regulated by the Food and Drug Administration?

Yes. Dietary supplements are regulated, although not in the way prescription or over-the-counter drugs are. Because dietary supplements are foods, and not drugs, the Food and Drug Administration (FDA) has the power to ensure that products on the market are both safe and accurately labeled. Before a product can be sold, a manufacturer must first notify the FDA of all intended label claims and ensure that they can be substantiated.

Unfortunately, some journalists have incorrectly reported that the supplement industry is unregulated, which is absolutely false. All supplements, including vitamins, minerals, herbs and specialty products, must conform to federal regulations that control manufacturing, labeling and advertising practices.

What are the benefits of dietary supplements?

There are many compelling reasons to consider dietary supplements as a complement to health care. While a good diet is the foundation for better health, research shows that most adults and children don't eat the way that they should. Supplements are easy to add to the daily diet, and this is often the first step that people take toward greater nutritional awareness and the adoption of other healthy lifestyle choices. Whether taking a multivitamin, herb or specialty product, people can and do live healthier lives by supplementing their diets.

Are dietary supplements safe?

Today, more than 70 percent of Americans trust dietary supplements and use them as a way to complement inadequate diets and maintain a healthy lifestyle. As more and more consumers experience the health benefits of dietary supplements, major research institutions are validating their experience and the efficacy and safety of these products.

According to a study published in the April 14, 1998 issue of the Journal of the America Medical Association (JAMA), adverse drug reactions, resulting from prescription and over-the-counter drugs, cause more than 100,000 deaths a year. Furthermore, the study estimates that 2.2 million people annually experience a serious adverse drug reaction.

In contrast, the FDA has on file approximately 2,500 "adverse event reports" (AERs), including 79 deaths, that may be related to dietary supplements. However, the FDA admits that these AERs may be flawed since there is "no certainty that an adverse event can be attributed to a particular product or ingredient." In addition, these AERs for supplements represent all reports to the FDA of adverse incidents allegedly connected to dietary supplements. (I can acknowledge that there may be unaccounted for cases of adverse events, but nowhere near on the level of their prescription counterparts and there are a lot of people taking supplements)

In addition, the February/March 1998 issue of Nature's Impact reports that dietary supplements are far safer to consume than foods, causing 1/60,000 as many deaths as foods each year. Consumers can check the safety of dietary supplements over the last two decades by comparing the incidence of deaths from all causes that are reported in either the Journal of Emergency Medicine or by the American Association of Poison Control Centers in Washington, D.C.

These scientific studies serve to substantiate the fact that dietary supplements have an enviable safety record when compared to other commonly consumed products.

DSHEA gives the FDA ample authority to ensure the safety of all dietary supplements sold to consumers and manufacturers' compliance with good manufacturing practices. Additionally, the law empowers the FDA to immediately remove any supplement from the market it deems unsafe. The real question for policymakers today is not whether the FDA has sufficient authority to protect consumers from unsafe practices, but whether the FDA is adequately enforcing the law.

What scientific studies show the efficacy of dietary supplements?

Each year, numerous studies are published in major medical journals that support the use of dietary supplements for the treatment of specific conditions, prevention of diseases or for general nutritional enhancement. Such studies can be found in The Journal of the American Medical Association, New England Journal of Medicine, American Journal of Cardiology, American Journal of Clinical Nutrition, and The Journal of the National Cancer Institute.

In addition, several leading research institutes and national associations such as John Hopkins University and the American Heart Association, have conducted and released studies on the benefits of dietary supplements.

What does DSHEA stand for?

DSHEA is the acronym for the Dietary Supplement Health and Education Act of 1994, legislation that regulates dietary supplements. DSHEA was passed overwhelmingly by Congress in October 1994 and was signed into law (PL 103-417) on October 25, 1994.

Why did DSHEA generate such strong Congressional support when it was passed in 1994?

At a time when the FDA was proposing to restrict access to dietary supplements, consumers became alarmed and urged Congressional action to recognize the value of supplements and the role they can play in promoting health and preventing disease. Congress wanted a new system that would guarantee consumer access to safe products and provide consumers with more information about the benefits of health supplements. Pleas from hundreds of thousands of health-conscious Americans prompted Congress to take much-needed action.

Under DSHEA, which government agencies have authority to ensure the safety of dietary supplements?

DSHEA increased the FDA's ability (again, you said FDA didn't have the authority) to preserve consumer safety, ensure product labels are informative and truthful, and set higher manufacturing standards. Additionally, the Federal Trade Commission has regulatory authority over claims supplement manufacturers make about their products in advertising, including the Internet. The dietary supplement industry also takes responsible action to implement rigorous standards for self-regulation including regular, independent laboratory testing of products for safety and authenticity.

How did the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994 affect the FDA's enforcement powers over the dietary supplement industry?

The passage of the DSHEA actually increased the FDA's enforcement powers over dietary supplements by establishing new labeling and potency standards. Violations of these standards are crimes. Under the DSHEA, the FDA has the power to:

* Refer for criminal action any company that sells a dietary supplement that is toxic or unsanitary [Section 402 (a)].
* Seize dietary supplements that pose an "unreasonable or significant risk of illness or injury" [Section 402 (f)].
* Stop a new dietary ingredient from being marketed if the FDA does not receive enough safety data in advance [Section 413].
* Stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard [Section 402 (f)].
* Obtain an injunction against the sale of a dietary supplement that has false or unsubstantiated claims [Section 403 (a), (r6)].
* Require dietary supplements to meet strict manufacturing guidelines (Good Manufacturing Practices), including potency, cleanliness, and stability [Section 402 (g)].

In addition, there are industry self-regulatory efforts that supplement these governmental powers (see Natural Products Association Leads the Industry's Self-Regulation), and the Federal Trade Commission has power over advertising and safety laws.
http://www.npainfo.org/index.php?src=faq&category=Dietary Supplements

 

[Geoff_M]

I don't have a lot of time here, but let me get thru what I can. I put numbers in your post and will respond with those numbers in mine.

1. I hope the FDA's own site is good enough for your supposed high standard.
What information must the manufacturer disclose on the label of a dietary supplement?

But the same goes for other "food" products. The label on a can of Coke or a loaf of bread is "complete", but minor ingredients are allowed to be listed by less descriptive terms like "flavors", "coloring", "emulsifiers", etc. There are exceptions in the FDA rules too. For example if the amount of an ingredient is "insignificant" it doesn't have to be listed on the label, but it may not be insignificant to an Olympic athlete. The labeling rules are also less stringent for small manufacturers.

2. The labeling isn't unreliable, it's simply UNENFORCED! The laws are already on the books to deal with these issue and we do NOT need further laws to combat these issues. The authority is ALREADY there.

Don't you find it a bit ironic that you're blaming the problem on a lack of enforcement against all too frequent abuse in an industry that you also don't think needs any more oversight?

3. Sorry, I just assumed I was speaking with someone slightly familiar with the process who would know that adding extras to a process would increase costs for said product. Giving carte blanche gives more power and authority over regulating supplements than food products (which you at least can equate that much), and ALSO prescription drugs in some instances. Putting links out to show you how the costs will be time consuming (though there are lots of sites if you actually did research the issue) and right now, I don't have time for that (Lost is on tonight, sorry) right now. If I get time, I will surely dig you up some links however.

I too said that there would be an "added" cost, the difference between your and my initial assertions is a couple orders of magnitude. You didn't say that there would merely be some added cost, you postulated that it would push the costs of dietary supplements out of the reach of ordinary citizens. OTC companies register their products with the FDA with no measurable financial harm to their customer who also absorb the cost of regulatory compliance. There's no rational reason to think that the experience of the supplement makers would be any different. The impact would be even less for the area of adverse reporting as supplement makers already are required to pass on to the FDA certain types of adverse events reported to them by customers and medical professionals to the FDA... they have the systems and business functions in place now. The costs to expand the types of events reported would not be great either.

As for what's in the product, yes, steroids is what did start the whole process of this new regulation.

While it's true that one of the bill's authors mentioned athletes that had been the victims of poorly listed ingredients in supplements that caused them to fail drug tests, if steroids were what this is all about, it's odd that in the 77 page GAO report that addressed the need for additional oversight of the supplements market, and whose recommendations serve as the basis of the bill, the word "steroid" doesn't appear once. Instead is cites the findings of an alarming increase in the rate of adverse reports concerning supplements, the large degree that the public is misinformed about supplements, and the roadblocks that have in the past prevented the FDA from acting quickly to address public health risks concerning supplements (Ephedra, on the other hand is mentioned dozens of times in the report).

Pyridoxamine occurs naturally in fish, chicken and other foods (http://en.wikipedia.org/wiki/Vitamin_B6), putting the FDA in the strange position of banning a substance from dietary supplements even though it is already present in the food supply.

I haven't researched it, but this sort of thing isn't quite that simple or even strange. Laws regulate the sale of cyanide, but apple seeds contain cyanide naturally. So should that be used as an argument against the regulation of the poison?

It’s not the first time the FDA has declared a natural molecule to be a “drug” while attacking nutritional supplements that contain the same molecule. A similar story unfolded with red yeast rice and the lovastatin molecules it contains that lower high cholesterol. The drug companies engaged in biopiracy, ripping off the molecule from red yeast rice to make their now-famous “statin drugs.” Once the statin drugs were patented, Big Pharma and the FDA went after red yeast rice, claiming the supplement was “adulterated with pharmaceuticals.”

Again, since lovastatin went generic at approximately the same time that red yeast rice extract was banned, how did this really help Merck???

5. Again, I don't understand why every question you ask has to do with cost to market. I didn't realize that that was the ONLY topic allowed for discussion.

It's not... but I asked for some specific examples on that point, and your reply didn't provide any real evidence.

Now, as for aspirin, I'll do some more legwork for you since you don't really seem to care about truth.

Nice... wow.

Maybe you'll enjoy this link? I won't even risk spoiling it by pasting much of it here. I'm just shocked you even needed any links on this subject because it's as 101 as it gets.

http://www.healthsentinel.com/jooml...can-war-casualties&catid=5:original&Itemid=24
The July 1998 issue of The American Journal of Medicine stated the following:

"Conservative calculations estimate that approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone. The figures of all NSAID users would be overwhelming, yet the scope of this problem is generally under-appreciated."

I can assure you, there are MANY, MANY, deaths a year from FDA approved drugs. Now, show how many deaths result from supplements?

Sorry, didn't proof this.

Three points:
1) The report tallies "estimated" theoretical deaths... not documented ones. But I won't quibble much and for the sake of argument let it go.
2) The article is about NSAIDs. Aspirin is an NSAID, but the weakest one of the bunch when stacked up against some like ibuprofen and heavy hitter Rx products like rofecoxib, celecoxib, and the rest. Your claim wasn't about NSAIDs vs. supplements, it was "aspirin". That's like saying how much more deadly Kia cars are vs. pick-up trucks and when pressed you point to data on all sedan highway deaths.
3) Where's your data on deaths associated with supplements? (ETA: I see you posted some as I typed this.) We know they happen. Part of the problem is that we don't have a clear picture of the answer... partly due to the lack of a meaningful way to analyze the adverse event data for supplements because of some of the problem the new bill is trying to address with reporting requirements and product registration. Previous posters that are advocates of supplements felt strongly about the need for consumer education about supplements, so why fight something that will aid with the knowledgebase?

DSHEA increased the FDA's ability (again, you said FDA didn't have the authority)

Yep... I was thinking "labeling" when it should have been "advertising" when talking about supplements and the FTC... my bad. You got me!!! My heavens!

(I can acknowledge that there may be unaccounted for cases of adverse events, but nowhere near on the level of their prescription counterparts and there are a lot of people taking supplements)

OK, now let's back out the number of lives saved by the use of prescription drugs vs. dietary supplements and see what the numbers look like? And again, I was questioning the unquestionableness of the fact that aspirin alone kills more people each year than do supplements.