JAMA article of July 5th

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http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full?etoc=

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JAMA. Published online July 5, 2011. doi: 10.1001/jama.2011.982

Dietary Supplements—Regulatory Issues and Implications for Public Health

1. E. Denham

<http://jama.ama-assn.org/search?author1=+E.+Denham & sortspec=date & submit=Su\

bmit> , PhD

[+] <http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full?etoc=>

Author Affiliations

1. Author Affiliation: Department of Communication Studies, Clemson University,

Clemson, South Carolina.

1. Corresponding Author: E. Denham, PhD, Department of Communication

Studies, 412 Strode Tower, Clemson University, Clemson, SC 29634

(bdenham@... ).

More author information

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KEYWORDS:

* CONSUMER PRODUCT SAFETY

<http://jama.ama-assn.org/search?fulltext=CONSUMER+PRODUCT+SAFETY & sortspec=date & \

submit=Submit & andorexactfulltext=phrase> ,

* DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT

<http://jama.ama-assn.org/search?fulltext=DIETARY+SUPPLEMENT+HEALTH+AND+EDUCATIO\

N+ACT & sortspec=date & submit=Submit & andorexactfulltext=phrase> ,

* DIETARY SUPPLEMENTS

<http://jama.ama-assn.org/search?fulltext=DIETARY+SUPPLEMENTS & sortspec=date & subm\

it=Submit & andorexactfulltext=phrase> ,

* GOVERNMENT REGULATION

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bmit=Submit & andorexactfulltext=phrase> ,

* LEGISLATION, DRUG

<http://jama.ama-assn.org/search?fulltext=LEGISLATION,+DRUG & sortspec=date & submit\

=Submit & andorexactfulltext=phrase> ,

* LEGISLATION, FOOD

<http://jama.ama-assn.org/search?fulltext=LEGISLATION,+FOOD & sortspec=date & submit\

=Submit & andorexactfulltext=phrase> ,

* PUBLIC HEALTH

<http://jama.ama-assn.org/search?fulltext=PUBLIC+HEALTH & sortspec=date & submit=Sub\

mit & andorexactfulltext=phrase> ,

* UNITED STATES FOOD AND DRUG ADMINISTRATION

<http://jama.ama-assn.org/search?fulltext=UNITED+STATES+FOOD+AND+DRUG+ADMINISTRA\

TION & sortspec=date & submit=Submit & andorexactfulltext=phrase> .

In October 1994, President Clinton signed into law the Dietary Supplement Health

and Education Act (DSHEA), and 17 years later, health experts, policy makers,

and industry lobbyists continue to spar over the legislation. Classifying

dietary supplements as a subcategory of food, DSHEA allowed supplement

manufacturers to market products without submitting proof of safety or efficacy

to the US Food and Drug Administration (FDA).1

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1> ​ Currently, for a tainted or otherwise hazardous product to be removed

from the supplement marketplace, an agency such as the FDA or the Drug

Enforcement Administration must offer evidence that the product is unsafe,

contains a controlled substance, or is absent ingredients listed on the product

label after the product has appeared in retail outlets.2

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2> For US health professionals, the fact that more than 150 million US

residents use dietary supplements should be a point of concern as many users

will almost certainly forgo conventional medical treatment in favor of using

products that may offer no medicinal value and taking health advice from

medically untrained sales representatives.3

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3> ​

Counterintuitively, DSHEA became law 5 years after the L-tryptophan amino acid

disaster of 1989, in which 38 individuals died and 1500 sustained adverse

reactions.1

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1> When the FDA appeared heavy-handed in its response to the supplement

catastrophe, industry lobbyists began applying pressure to lawmakers, especially

those with a vested political interest in the economic success of supplement

companies. US Senator Orrin Hatch, representing Utah, a major producer of

dietary supplements, responded to industry appeals by coauthoring DSHEA and

shepherding it through Congress. In doing so, Hatch sought to help manufacturers

enjoy the freedom they had profited from during the 1980s after the Proxmire

Amendment of 1976 barred the FDA from using potency levels to classify dietary

supplements as drugs.4

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4> ​ To date, no public official has defended the interests of the supplement

industry to a similar extent.

In 2009, a US Government Accountability Office (GAO) report found that

“consumers are not well-informed about the safety and efficacy of dietary

supplements and have difficulty interpreting the labels on these products.â€2

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2> In fact, one of the most significant problems with DSHEA is that it allows

structure and function claims to appear on product labels; as long as products

do not claim to treat, prevent, or cure specific diseases, they can enter and

remain in the marketplace.1

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1> ​ The concern is that consumers may not differentiate between technical

descriptions and marketing language and may attempt to use dietary supplements

in place of medicines that have been tested in rigorous trials. To that end, a

2010 GAO investigation found that sellers of dietary supplements may actually

encourage consumers to substitute supplements for physician-prescribed

medications.3

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3>

In preparing its 2010 report, the GAO investigated 22 retailers of herbal

dietary supplements, hiring an accredited laboratory to examine 40

single-ingredient supplements for the presence of lead, arsenic, mercury,

cadmium, and assorted pesticides.3

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3> ​ Although none of the supplements qualified as having an acute toxicity

hazard, trace amounts of at least 1 contaminant were found in 37 of 40

products.3

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3> According to the GAO, more troubling than the contaminants was the dubious

and potentially hazardous advice offered to investigators who had posed as

elderly customers. The GAO gathered written materials from online retailers,

observing claims of treating, preventing, and curing conditions such as

diabetes, cancer, and cardiovascular disease. Among the more egregious marketing

efforts were claims that garlic could be taken in place of high blood pressure

medication and that ginkgo biloba could be used to treat Alzheimer disease,

depression, and impotence.3

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3> ​ Studies conducted by the National Center for Complementary and

Alternative Medicine have shown that ginkgo biloba, in particular, does not

reduce the risk of cancer nor does it prove effective in reducing high blood

pressure among older adults.5

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5> Careful review of National Center for Complementary and Alternative Medicine

studies reveals a similar lack of efficacy for garlic, chromium picolinate, and

St 's wort.5

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5> ​

On occasion, policy makers have attempted to address at least some of the

problems associated with dietary supplements. For example, citing the 2009 GAO

report,6

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6> Senators McCain and Byron Dorgan introduced the Dietary Supplement

Safety Act (S 3002) in February 2010.7

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7> ​ Although this act did not propose significant changes in efficacy

assessment, it would have required supplement manufacturers to register with the

FDA and disclose all product ingredients. The legislation also would have given

the FDA mandatory recall authority, the lack of which had resulted in the agency

taking 10 years to remove ephedra from the marketplace.6

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6> But S 3002 never became law. With the support of industry lobbies, Hatch and

Senator Tom Harkin persuaded McCain and Dorgan to drop S 3002, introducing in

its place the Dietary Supplement Full Implementation and Enforcement Act (S

3414).8

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8> ​ Announced on May 25, 2010, S 3414, which also did not become law,

proposed allocating additional monies to the FDA such that the agency could

enforce DSHEA more effectively. Hatch has long argued that funding is the key to

enforcement success, perhaps because the argument cannot be falsified; that is,

whenever problems with DSHEA arise, proponents can simply request additional

funding for enforcement efforts. However, such bills have amounted to little

more than the perpetual tabling of legislative reform, leaving the FDA in the

untenable position of having no premarket screening authority while

simultaneously facing critics who blame the agency for not enforcing DSHEA.

Few industries enjoy the level of protection DSHEA provides supplement

manufacturers. Legislators, with the support of industry lobbies, continue to

find ways to relax regulations. For example, on April 5, 2011, US

Representatives Chaffetz and Polis introduced the Free Speech About

Science Act (HR 1364),9

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9> which would allow supplement manufacturers to cite research showing health

benefits without the FDA classifying corresponding supplements as unapproved

drugs. Given that products touted as scientifically formulated already may be

marketed by companies that gather and analyze data on a proprietary basis and

then cite DSHEA as a means of keeping results private and shielded from robust

peer review, the intent of this legislation might be questioned. The basic

tenets of science are frequently ignored by companies that use the term to lend

credence to their industry, and it is safe to assume that supplement

manufacturers will not make an announcement each time a study finds no

relationship between a dietary supplement and a health condition. For cases in

which the null hypothesis is actually rejected, HR 1364 would allow industry

leaders to promote their findings—a practice with which they appear

comfortable.

Since October 1994, when DSHEA became law, industry statements about life in a

free society and the rights of consumers have frequently overridden practical

arguments about the safety and efficacy of dietary supplements, resulting in a

conversation that has privileged demagoguery over informed debate. The

conversation needs a more sophisticated tone and the FDA took a positive step in

2007, issuing a rule on good manufacturing practices.10

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10> ​ Ideally, good manufacturing practices will help reduce availability of

products containing contaminants such as pesticide residue or oxidation

by-products; however, as the GAO investigations revealed, there is still room

for improvement. Physicians should support future efforts to improve or reform

DSHEA because individuals with serious medical conditions may be relying on

products with no medicinal value. Like dietary supplements, the regulations

should be efficacious and formulated for legitimate ends.

Next Section

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Author Information

1. Author Affiliation: Department of Communication Studies, Clemson

University, Clemson, South Carolina.

Corresponding Author: E. Denham, PhD, Department of Communication Studies,

412 Strode Tower, Clemson University, Clemson, SC 29634 (bdenham@...

).

Published Online: July 5, 2011. doi:10.1001/jama.2011.982

Conflict of Interest Disclosures: Dr Denham has completed and submitted the

ICMJE Form for Disclosure of Potential Conflicts of Interest and none were

reported.

Previous Section

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REFERENCES

1. 1.

<http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full?etoc=#xref\

-ref-1-1>

1. Hill JA

.. Creating balance: problems within DSHEA and suggestions for reform. J Food Law

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<http://www.nationalaglawcenter.org/assets/bibarticles/hill_balance.pdf> .

Accessed April 7, 2011.

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<http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full?etoc=#xref\

-ref-2-1>

1. US Government Accountability Office

.. Dietary supplements: FDA should take further actions to improve oversight and

consumer understanding. January 2009. Publication No. GAO-09-250.

http://www.gao.gov/new.items/d09250.pdf

<http://www.gao.gov/new.items/d09250.pdf> . Accessed April 8, 2011.

3. 3.

<http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full?etoc=#xref\

-ref-3-1>

1. US Government Accountability Office

.. Herbal dietary supplements: examples of deceptive or questionable marketing

practices and potentially dangerous advice. May 2010. Publication No.

GAO-10-662T. http://www.gao.gov/new.items/d10662t.pdf

<http://www.gao.gov/new.items/d10662t.pdf> . Accessed April 7, 2011.

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<http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full?etoc=#xref\

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1. US General Accounting Office

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http://archive.gao.gov/d43t14/149513.pdf

<http://archive.gao.gov/d43t14/149513.pdf> . Accessed June 3, 2011.

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<http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full?etoc=#xref\

-ref-5-1>

1. National Center for Complementary and Alternative Medicine

.. Research results for dietary herbal supplements: selected results of

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http://nccam.nih.gov/research/results/topics/index.php?title=Dietary_and_Herbal_\

Supplements

<http://nccam.nih.gov/research/results/topics/index.php?title=Dietary_and_Herbal\

_Supplements> . Accessed June 4, 2011.

6. 6.

<http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full?etoc=#xref\

-ref-6-1>

Senator McCain introduces the Dietary Supplement Safety Act of 2010 [press

release]. February 3, 2010. US Senator McCain Web site.

http://mccain.senate.gov/public/index.cfm?FuseAction=PressOffice.Speeches & _Conte\

ntRecord_id=952dda07-b71c-4034-4f34-c38974978f7d

<http://mccain.senate.gov/public/index.cfm?FuseAction=PressOffice.Speeches & _Cont\

entRecord_id=952dda07-b71c-4034-4f34-c38974978f7d> . Accessed June 3, 2011.

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<http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full?etoc=#xref\

-ref-7-1>

Dietary Supplement Safety Act of 2010, S 3002 , 111th Cong, 2nd Sess (2010).

8. 8.

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-ref-8-1>

Dietary Supplement Full Implementation and Enforcement Act of 2010, S 3414 ,

111th Cong, 2nd Sess (2010).

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-ref-9-1>

Free Speech About Science Act of 2011, HR 1364 , 112th Cong, 1st Sess (2011).

10.10.

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-ref-10-1>

1. US Food and Drug Administration

.. Current good manufacturing practices (CGMPs): dietary supplements. FDA Web

site.

http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformati\

on/RegulationsLaws/ucm079496.htm

<http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformat\

ion/RegulationsLaws/ucm079496.htm> . Accessed June 3, 2011.

S. Kalman PhD, RD, FACN

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