GAO report on dietary supplement flaws released today in Senate hearing

One of the things described in the article that really made me cringe was the mention of how a salesperson said a garlic supplement could be taken instead of blood pressure medication. I hate to think how often people must be hearing that kind of thing.

Ha! The NYT is advertising prostate supplements on the right next to the article. Ad placement win.

@Liz, this is fairly common. In fact, the FTC has a sting operation operation about 10-15 years ago where agents posed as HIV/AIDS patients and asked health food store clerks for advice on products to take. (FTC differs from FDA in this regard by focusing on product representation regardless of whether it is a drug, supplement, washing machine, etc.).

In a 1998 pharmacy education paper I wrote with a great B.S.Pharm. student on teaching herbal medicine in the Pharm.D. curriculum, I encouraged fellow profs to issue an assignment to students to go to supplement retailer and observe the "patient counseling" that occurs in those environments. (free PDF here, see point 5 in Figure I.)

@Marcy, I love auto-generated ads. When I was looking at comments on yesterday's synthetic marijuana post in my Gmail account, several ads came up with where to buy these still-legal supplements!

The NYT article stated that 1994 legislation allowed supplement firms to market products without first getting FDA approval. This is only true for supplements on the market before 1994. Any new supplement introduced after 1994 does require FDA approval. The New Dietary Ingredient regulations require that companies provide the FDA with evidence their product is safe. The FDA has rejected approximately 70% of NDI applications since 1994, thereby keeping many potentially unsafe supplements off the market.

Supplement companies that adulterate, mislabel, or make false claims for their products are breaking the law. The FDA has full legal authority to bring criminal charges against such companies. The problem has always been one of enforcement. We know that former FDA commissioner David Kessler had a policy of intentional non-enforcement of DSHEA regulations. He hoped that an unregulated industry would hang itself, resulting in calls for harsher, more restrictive supplement regulations. This is precisely what has occurred.

Publicly the FDA has always pleaded lack of funds to properly enforce DSHEA. To remedy this Senators Hatch and Harkin have just introduced Dietary Supplement Full Implementation and Enforcement Act of 2010.

@Jeff

I suspect you have cherry-picked and misrepresented what you wrote. More than 15 years since DSHEA's passage, this is the first I've heard that new (post 1994) supplements require FDA approval of any sort. Safety data has always been "required" for supplements; but the FDA has never approved those claims (and safety claims are often flimsy). Supplements never go through the IND system, so your stats are irrelevant.

Who are the "we" that know that Dr. Kessler "had a policy of intentional non-enforcement of DSHEA regulations."

The FDA does lack sufficient funding to properly regulate even the few limits on Big Suppla- it took ten years to ban ephedra despite the common knowledge that it was killing people in search of mere weight-loss. Die young and leave a pretty corpse: the motto of Big Suppla.

Nothing advanced by Harkin and Hatch is going to impede the ability of Big Suppla to avoid proving safety and efficacy of any shrub they want to package and sell...

Much of the testimony heard by the members of the Senate Select Committee on Aging will almost certainly include the usual supplement-bashing: Repeal DSHEA, restrict consumer access to supplements, etc.. It may be too much to expect that the Senators will be informed about studies showing the health of seniors could be improved by taking supplements .

As someone who reads the NYT Health section regularly, I can report its editors go out of their way to avoid telling readers about studies which demonstrate health benefits of dietary supplements.

@Joe: Don't blame your ignorance on me; I have misrepresented nothing. You've never heard of the New Dietary Ingredient Regulations? They're part of 1994's DSHEA - You can read all about them at the FDA's website. We know about the FDA's policy under Kessler because former FDA chief counsel Peter Barton Hutt told us about it.

S.510, the Senate's Food Safety bill will probably pass sometime this year. It will, for the first time, give the FDA mandatory recall authority over all food products and dietary supplements. This is supported by industry trade groups like the Council For Responsible Nutrition. It will ensure unsafe products can be recalled quickly - no long, drawn-out legal process will be required.

Here's an account of the May 25 hearing held by the Special Senate Committee on Aging:

http://www.naturalproductsinsider.com/articles/2010/05/senate-hearing-q…

@Jeff,

I rue my ignorance, I grieve about it over long winter nights.

If you are right about NDI applications, it does not amount to much- they do not compare to full-fledged attention given to drugs.

Your claim that Kessler did not want to enforce the law is contradicted by the press-release that you cited. And your citation for the benefits of supplements is not a blanket endorsement. You basically cite press releases from Big Suppla for your background.

Read Dan Hurley's book (Natural Causes) and you will see that DSHEA was a response to worries that the FDA would regulate the supplement industry and make it hard for them to sell useless and harmful products. As I said- any new law promoted by Sen.s Hatch and Harkin, and lauded by the industry, is unlikely to change much of that.

@Joe, this makes the fourth or fifth time in the past year you've tried to steer readers toward Dan Hurley's innacurate, misleading book. I read it and posted a review at Amazon.com. The book simply isn't credible.

Previously you have stated all supplements should be banned. It's clear you have no use for reasonable regulation - the kind which prohibits marketing of unsafe products but preserves consumer access.

Natural Products Insider is an excellent, independant source of information about the natural products industry. They do accept supplement company advertising, but then so does ScienceBlogs.

The Alliance for Natural Health has posted a rebuttal to The NYT article quoted by Abel. The figures they cite regarding herbal supplement lead levels make it clear how overblown was the MSM response to the GAO report:

http://www.anh-usa.org/senate-hearing-headlines-the-media-gets-it-wrong…

http://www.scientificamerican.com/article.cfm?id=herbal-supplement-dang…

According to the above-linked article, fraudulent claims by point-of-sale purveyors are also common.

@Jeff, You must say what is inaccurate in Hurley's book in order to be taken seriously. We know escharotics can produce bad results. We know Big Suppla spent 10 years fighting the FDA ban on ephedra. The contamination of other herbs with aristolochia is well documented. Ginkgo, saw palmetto and echinacea are still sold despite lack of evidence for efficacy.

DSHEA allows Big Suppla to sell anything, with severely limited oversight.

In my revieiw of Dan Hurley's Natural Causes, I list my complaints. Go to Amazon's page for the book and click on the review titled "Biased and Innacurate", by J. Engle.

Saw palmetto has a long history of safe use, and there is evidence for its efficacy

False claims by sales clerks (and a few supplement companies) are a problem, mainly due to lack of enforcement by the FDA and FTC. This would be remedied by The Dietary Supplement Full Implementation and Enforcement Act of 2010 (Hatch & Harkin's bill).

The Scientific American article states incorrectly that "only manufacturers need to determine if a supplement can stand up to claims made about its benefits." The FDA requires that, before making structure/function claims, companies have substantiation that the claims are truthful and not misleading. The FDA must be notified of the claim within 30 days of first marketing the product. The FDA may ask to review the substantiation; If the evidence is insufficient, the claim will be disallowed.

@Jeff, I saw your complaints about "Natural Causes" at Amazon, they are rather feeble; from the whole book- you only complained about the inclusion of tryptophan and listing of homeopathy.

As for saw palmetto, its safety has not been properly studied, and its efficacy failed in the best test ( http://scienceblogs.com/terrasig/2007/07/another_botanical_clinical_tri… ). Herbal purveyors have lax standards for efficacy claims and are not in any hurry to remove products (echinacea, gingko, etc.) thatshow no effect in rigorous studies. As for safety, consider aristolochia's centuries of use after childbirth. Is it beneficial, who knows? But total kidney failure followed by cancer (in those lucky-enough to get kidney transplants) mitigates against its use.

In fact, lots of herbs with centuries of "safety" are no longer used since critical thinkers studied them (coltsfoot, comfrey, chaparral, sassafras etc.).

Jeff says the Scientific American article states incorrectly that "only manufacturers need to determine if a supplement can stand up to claims made about its benefits." And then deviates into the niceties of FDA requirements for labeling. It is true that the manufacturer must satisfy the FDA when they make "structure/function" claims. That is why proponents avoid making them in favor of vague claims about "supporting" health; such claims avoid scrutiny under DSHEA.

The dangers of Aristolochic Acid are well-known; this is precisely why FDA banned its importation into this country.

Joe seems to be confused about definitions. Structure/function claims are statements that describe the effect a dietary supplement may have on the structure or function of the body. Example: "Zinc promotes healthy immune system function." The FDA allows this structure/function claim due to the abundance of evidence supporting it.

NCCAM is famous for its poorly designed studies - the Saw Palmetto study was one of these. In recent years there has been an explosion of research into botanicals. I did a ScienceDaily search for a Mayo Clinic trial which involved chronic lymphocytic leukemia patients using green tea extract. The search results list a number of studies showing genuine health benefits for just this one substance:

http://www.sciencedaily.com/search/?keyword=Mayo+Clinic+Green+Tea+Extra…+

@Jeff, Yours is the arrogance of ignorance you can read about it here, as well as the citations http://photoninthedarkness.com/?p=140

Of course Aristolochia is banned here; but that is the result of science- not ignorant herbalists who recommended it after childbirth for centuries because it was "safe and effective." That also did not stop "dietary supplement" manufacturers from including it in their products because their "quality" standards are lacking and contamination is likely.

As for NCCAM, it was enabled by the same idiots that gave rise to DSHEA. It is empowered to study "health care" ideas that are too stupid to be funded by normal means through NIH. Unfortunately for the morons- it is pretty effective at ruling out AM. You can read about it (and DSHEA) here http://www.sciencebasedmedicine.org/ Note in particular the post(s) by Dr. Sampson.

What Joe says is correct: as a result of science we know now that aristolochic acid is a carcinogen. Science is also validating the potential of many botanicals to prevent and even treat some diseases. For example here's an article summarizing recent research into Pomegranate:

Is Conventional Pomegranate Extract Enough?, by Julius Goepp, MD.

In a Nov. 2009 article Dr. Goepp wrote about a 2006 clinical trial conducted by urologists at the University of California. They found that simply by drinking pomegranate juice daily, prostate cancer patients increased their PSA doubling time from 15 months (before supplement) to 54 months (after supplement).

It's only because of DSHEA that standardized extracts of these beneficial botanicals are available to everyone as non-patented, affordable dietary supplements.

@Jeff,

After accusing me of ignorance about the DSHEA, and confusion about the meaning of "structure-function" claims (which are allowed for drugs; but not for unproven shrubbery). You seem to have abandoned claims for saw palmetto in favor of pomegranate.

First, I must ask Jeff how "DSHEA ... standardized extracts"? Maybe I really am ignorant of DSHEA, I am (after all) a chemist who does not pore over legislation. Or maybe I know enough about it to know that it does not truly promote scientific inquiry.

Jeff's citation to a magazine article about pomegranate is not very helpful. It fails to cite the article that claims pomegranate's ability to reduce the doubling-rate of PSA in prostate cancer (which is: http://clincancerres.aacrjournals.org/content/12/13/4018.full.pdf ).

A search of Medline for clinical trials of 'pomegranate and prostate' only delivers that article (and another that is not really a clinical trial). The number of patients in the trial is small, and there is no control arm. It examines the PSA doubling-time before and after receiving conventional treatment. It would be charitable to say that it is food for thought.

To tell you the truth, Jeff, I am always thrilled at the discovery of a conceptually new drug; no matter whence it is derived. I also am aware that natural products represent an enormous storehouse of potentially useful compounds. But I doubt that most of "dietary supplements" provided by Big Suppla (and small, dedicated herbalists, alike) are effective for their promoted uses; and you have no reliable data to prove me wrong.

And that doesn't even get into the question of safety- which aristolochia, ephedra, comfrey, sassafras etc. failed at after centuries of promotion by herbalists. Regulated drugs are constantly scrutinized for adverse reactions, herbs have to be pretty bad before anyone in the industry takes notice. Here is where you may know something that I don't- can you cite any supplements that have gone off the market because the purveyors noticed they were inherently dangerous?

Even if you can cite a few examples of Big Suppla (which is, increasingly, Big Pharma), or if pomegranate turns out to be the panacea that the article you linked says it is, that leaves hundreds of unsubstantiated claims to safety and efficacy out there.

According to Joe no structure/function claims are allowed for plant extracts marketed as dietary supplements. Not true. For example the FDA allows these structure/function claims for green tea extract:

"Supports healthy immune function."
"Helps maintain a healthy cardiovascular system."

The FDA's website explains exacly which claims are allowed for dietary supplements:
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm

The FTC and FDA can, and will, file charges against companies making stucture/function claims for which there is insufficient evidence.

Joe provides a link to the pomegranate study I referred to, and makes this statement:

It examines the PSA doubling-time before and after receiving conventional treatment.

Wrong. It examines the PSA doubling time of prostate cancer patients before and after being treated with pomegranate juice. From the study:

"In this study of 46 men with recurrent prostate cancer, treatment with pomegranate juice was associated with statistically significant prolongation of PSADT, durable prolongation of disease stabilization, and significant effects on exploratory laboratory assays, such as the patientsâ serum antioxidant status, and on prostate cancer in vitro cell growth and apoptosis."

The results were sufficiently positive that a randomized, doubleblind, three-arm, placebo-controlled study using pomegranate juice is already underway.

Regarding adverse reactions, the FDA regulates dietary supplements and OTC drugs exactly the same way: Companies are mandated to report all serious adverse events to the agency. Since the passage of DSHEA in 1994 only one legal dietary supplement (ephedra) has been taken off the market because of deaths caused. Supplements have an excellent safety record, especially when compared to pharmaceuticals.

Joe seems to think botanicals only have value as a source of drug discovery. Researchers around the world think differently - they understand plant extracts often possess many bioactive substances which work synergistically to produce an effect upon the body.

@Joe: The FDA allows this structure/function claim for saw palmetto:

"Supports healthy function of the prostate gland and urinary tract."

Most studies, like those included in this meta-analysis, have concluded that saw palmetto is effective at relieving symptoms of BPH:

1. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review.

Note the conclusion: "Compared with finasteride, S repens produces similar improvement in urinary tract symptoms and urinary flow and was associated with fewer adverse treatment events."

@Jeff, I was confused about "structure/function" claims. I note: "If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," ..." In other words, such claims must be vague since there is insufficient data support claims of actual benefit.

I was also wrong about the pomegranate study. However, it is still too small, and uncontrolled, to be touted as a reason for selling the stuff.

As for your cited review about the benefits of Saw Palmetto, the same page has this link http://www.ncbi.nlm.nih.gov/pubmed/19370565 to an updated review which finds no benefit from SP.

As for synergy in natural products, there is very little evidence of it; and many of the claims could actually represent mere additivity. Nevertheless, we know how to detect such interactions and use them to our benefit.

The apparent safety of supplements may represent lack of data as well as their lack of significant biological activity.

Here's a recent article:

Optimal Prostate Defense Requires a Multi-Modal Strategy

"This article reviews eight clinically supported interventions with outstanding safety records to protect prostate health."

@Jeff,

What you are asking me to do, at base, is sort through a "data dump" in a lay magazine and see if there is anything that is worthwhile. If you think there is anything significant in high-quality, primary, scientific journals- you can identify them for consideration.

Note that magazines written by and for CAM enthusiasts do not qualify. Although it is usually easy to spot the flaws in the research, long ago I tired of spending my time doing so.

I should be more explicit- the research has got to be clinical, in humans.

@Joe: Point taken. As an aging male maybe I just have a concentrated interest in the subject of prostate health. The article points up a principal strength of natural products: Each compound described has more than one mode of action (saw palmetto has several). From the final paragraph:

" Each works by uniquely different mechanisms to confer multiple benefits and effective protection. Through a combination of direct impact on prostate tissue and powerful modulation of gene expression, these compounds operate through synergistic and complementary modes of action, attacking BPH and prostate cancer on multiple fronts. Compared to single-target drugs that provide only partial relief (and come with undesirable side effects), these natural interventions provide aging men with a safe, low-cost, alternativeâfor lifelong prostate health."

The article does refer to several human clinical trials.

@Jeff wrote "The article points up a principal strength of natural products: Each compound described has more than one mode of action (saw palmetto has several)."

My point is the data do not support that claim (which is quite common in unscientific herbalism). Think about this logically, (as I have cited) the latest and best data do not support efficacy for saw palmetto. How can it have multiple modes of action when it does not even work?

Here is another mistake unscientific herbalists make- they posit that natural products are free of side effects. The data only supports that to the extent that those (gentle) herbs and spices are medicinally inactive. The right amount of digoxin (foxglove) is valuable in treating heart disease; however, just a little too much can leave you seriously dead. Salicylic acid (SA, many natural sources) is effective for treating arthritis; but it is brutal on the GI system. Science has improved on SA- making aspirin.

Certainly, the latest article you cited does refer to human "clinical" trials. However, I doubt that any of them is sufficiently well-designed and large-enough to justify profiting from selling said herb. A common failing of unscientific herbalists is they are insufficiently critical of evidence. Thus my point- if you think there is any valid clinical data to support a claim, please show it to me rather than ask me to find that "needle" in the haystack of more than 100 citations.

Joe has presented two arguments: 1) He gives the example of two obscure, potentially harmful herbs which nobody uses (aristolochia, foxglove) to argue that all herbal products should be banned or greatly restricted. 2) Only those herbs which have serious side-effects could possibly be effective for anything.

Studies:

1. Updated meta-analysis of clinical trials of Serenoa repens extract in the treatment of symptomatic benign prostatic hyperplasia.

2. Efficacy and safety of a combination of Saw Palmetto and Nettle Root extract in lower urinary tract symptoms--long-term follow-up of a placebo-controlled, double-blind, multicenter trial.

Google "pubmed/10971268" to read an abstract of the original muticenter trial.

3. Google "pubmed/16635963" to read this abstract: Nettle Root extract for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study.

I include only two links to avoid the spam filter.

Are these trials irrefutable, conclusive proof that these extracts are effective? Are they the equivalent of Phase 3 drug trials? No. But they are solid clinical evidence. All the substances mentioned in the article demonstrated a notable lack of adverse side-effects. They provide a clear choice for someone with prostate issues: try a combination of these safe, natural extracts, or take a drug like Proscar, with its potentially devastating side-effects (like loss of sexual function).