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Adverse Events Reporting (AER) Act for dietary supplements and other botanicals

Adverse events reporting on botanicals
Article on the Adverse Events Reporting Act for dietary supplements and other botanicals.
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http://abc.herbalgram.org/site/PageServer?pagename=05_01_AER_Labeling_Guidance
FDA Publishes Draft Guidance on Labeling Requirements of AER Act

The US Food and Drug Administration (FDA) announced in the FederalRegister on January 2 that it has issued a draft guidance to assist thedietary supplement industry in complying with the labeling requirementsof the Dietary Supplement and Nonprescription Drug Consumer ProtectionAct ("the AER Act").1 The AER Act requires marketers of dietarysupplements and over-the-counter (OTC) drugs to maintain records of alladverse events reported to the manufacturer and submit reports to theFDA of those incidents meeting the definition of "serious" adverseevents. Comments regarding this draft guidance must be submitted to theFDA by March 3.
According to the draft guidance, dietary supplement labels must includea domestic address or phone number for receiving adverse event reports.The FDA has concluded that this entails either a full US mailing address(complete with street address or post office box number) or a phonenumber with an area code. The FDA further recommends in its guidancethat all dietary supplement labels include a clear, prominent statementinforming consumers that the domestic address or phone number may beused for reporting serious adverse events associated with the product.Although the AER Act went into effect in December of 2007, the FDA hasstated that it intends to exercise enforcement discretion for the newlabeling requirements until January 1, 2009. The requirement to documentadverse events and report serious events to the FDA is currently inforce as of December 22, 2007.
Two prominent industry trade organizations have already expressed someconcerns about the recently issued guidance. The American HerbalProducts Association (AHPA) recently stated in a press release that ithas previously gone on record as arguing that a full US mailing addressis unnecessary for product labels.2 AHPA pointed out that long-standingregulations for foods, drugs, medical devices, and cosmetics have heldthat a company's place of business need not include a street address ifit can be found in a city directory. According to AHPA, FDA explainedthat it has suggested a full mailing address because the agency believesconsumers may choose to not submit a report if they believe it would notbe received due to an incomplete address.
"This is really quite stunning," stated AHPA President Michael McGuffin,according to the AHPA press release.2 "If FDA is stating that theinformation that has been required on food, drug, medical device andcosmetic labeling since 1938 is somehow inadequate to communicate toconsumers, AHPA assumes that FDA would seek a global change in the lawto address any perceived inadequacy and would not single out thisindustry and the OTC drug industry as targets for its hypothesis."
AHPA also objected to FDA's recommendation that companies include astatement about the use of the address or phone number for submittingserious adverse event reports, which AHPA argued "must be seen as awarning statement."
"This was not the intent of the law, and the Senate Committee on Health,Education, Labor and Pensions clearly stated in its official report onthis bill that it 'does not require the label to make any statementother than providing the address or phone number,'" said McGuffin.2
The Council for Responsible Nutrition (CRN) has also recently expresseddisappointment with the guidance document, arguing that it too haspreviously gone on record as opposing such changes in labeling.
"We are dismayed that FDA has introduced these new labelingrequirements, seemingly out of nowhere, particularly because there is nolegislative authority in the statute for these requirements," said SteveMister, president and CEO of CRN (e-mail, January 10, 2008). "It'sparticularly troubling that the agency has chosen to try to impose theserequirements through a draft guidance. These kinds of sweepingdeviations from the stated intent of Congress at least require fullnotice and comment rulemaking."
CRN first learned of FDA officials' interest in changing the labels inthe wake of the passage of the AER law last spring, Mister said.
In a letter sent to Robert E. Brackett, PhD, then-director of the Centerfor Food Safety and Applied Nutrition at the FDA in July of 2007, CRNargued then against both the perceived necessity of a full mailingaddress and of adding a statement about the address and phone number'suse for reporting serious adverse events, for reasons similar to thosegiven by AHPA.3
"The primary purpose of this legislation has always been to assureconsumers that when a company receives a complaint of a serious adverseevent, it will provide that information to FDA. The agency has pastedits own agenda onto the intent of Congress and tried to do so withoutusing the proper administrative procedures," said Mister.
CRN further commented that such label changes would place an undueburden on industry and that manufacturers would need at least 3 years tochange labels on new products being placed on the market.
"We have heard from several of our members that FDA has farunderestimated the financial projections for manufacturers to revisetheir labels," said Mister. "The agency doesn't seem to appreciate thetime and expense involved to make even minor changes to supplementlabeling. Someone, potentially consumers, will have to absorb thesecosts. The agency should reevaluate whether these mandatory changeswould really best serve consumers given these added costs."
The FDA released a prior guidance document in October of 2007 concerningthe submission and recordkeeping of serious adverse events of dietarysupplements and OTC drugs required under the AER Act.4 An articlecovering this guidance document was published in the October issue ofHerbalEGram.5
-Courtney Cavaliere

References1US Food and Drug Administration. Draft guidance for industry: questionsand answers regarding the labeling of dietary supplements as required bythe Dietary Supplement and Nonprescription Drug Consumer Protection Act;availability. 73 Federal Register 197. January 2, 2008. Available at:http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2008_register&position=all&page=197. Accessed January 2, 2008.2FDA issues labeling guidance on SAER law [press release]. SilverSpring, MD: American Herbal Products Association; January 2, 2008.3Mister S. Letter to RE. Brackett (CFSAN, FDA). July 31, 2007.4US Food and Drug Administration. Draft guidance for industry: Questionsand answers regarding adverse event reporting and recordkeeping fordietary supplements as required by the Dietary Supplement andNonprescription Drug Consumer Protection Act; availability. 72 FederalRegister 58313. October 15, 2007. Available at:http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-5074.pdf. Accessed January 7, 2007.5Cavaliere C. FDA publishes draft guidance on serious adverse eventreports. HerbalEGram. October 2007;4(10). Available at:http://abc.herbalgram.org/site/PageServer?pagename=04_10_SAER_Guidance&JServSessionIdr012=xvjgf745d2.app13a. Accessed January 7, 2008.

Smoking predicts suicidality: Findings from a prospective community study

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T2X-4R5G7YS-2&_user=10&_coverDate=11%2F19%2F2007&_alid=673515146&_rdoc=3&_fmt=summary&_orig=search&_cdi=4930&_sort=d&_docanchor=&view=c&_ct=26&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=1f6c6c47f0ffd64e94006aa6f825a709

Research report

Smoking predicts suicidality: Findings from a prospective community study

Thomas Bronischa, , , Michael Höflera, b and Roselind Lieba, c
aMax-Planck-Institute of Psychiatry, Clinic and Clinical Psychology and Epidemiology, Kraepelinstreet 2-10, 80804 Munich, Germany
bTechnical University of Dresden, Clinical Psychology and Psychotherapy, Mommsenstreet 3, 01187 Dresden, Germany
cUniversity of Basel, Epidemiology and Health Psychology, Missionsstrasse 60-62, 4055 Basel, Switzerland
Received 4 July 2007;
revised 10 October 2007;
accepted 10 October 2007.
Available online 19 November 2007.

Abstract
Background
The temporal relationship between smoking and suicidality is not yet clear. This article examines associations between smoking and suicidality and their temporal ordering of onset.
Methods
Baseline and four-year follow-up data were used from the Early Developmental Stages of Psychopathology (EDSP) study, a prospective longitudinal study of adolescents and young adults in Munich, Germany. We assessed smoking (occasional and regular), nicotine dependence, suicidal ideation and suicide attempts using the standardized Munich-Composite International Diagnostic Interview (M-CIDI).
Results
Suicide ideation and suicide attempts were strongly associated with occasional and regular smoking and nicotine dependence at baseline (Odds ratios [OR] range from 1.4 to 16.4). In the prospective analyses, prior occasional, regular smoking and nicotine dependence increased the risk for new onset of suicide ideation (OR range from 1.5 to 2.7) and prior regular smoking and nicotine dependence increased also the risk for onset of suicide attempt(s) (OR range between 3.1 and 4.5). Pre-existing suicidality could not be shown to be associated with subsequent smoking or nicotine dependence. Associations remained stable when participants who fulfilled DSM-IV-criteria for major depression were excluded.
Limitations
The sample is confined to an age cohort of 14 to 24 years. No completed suicides could be observed.
Conclusions
The presence of associations between prior smoking and subsequent suicidality, in concert with the lack of associations between prior suicidality and subsequent smoking suggests the existence of an independent pathway from smoking to suicidality.

Keywords: Suicide attempts; Suicide ideas; Smoking; Community study

Article Outline
1. Introduction
2. Methods
2.1. Design
2.2. Sample
2.3. Diagnostic assessment
2.4. Assessment of suicidality
2.5. Definition of smoking and nicotine dependence
2.6. Statistical analyses
3. Results
3.1. Lifetime prevalence of smoking, nicotine dependence and suicidality at baseline
3.2. Baseline associations between smoking behavior and suicidality
3.3. Is the presence of pre-existing smoking related to the risk for onset of suicide ideation and suicide attempts during the four year prospective follow-up interval?
3.4. Does the presence of pre-existing suicidality predict the risk for onset of smoking during the four year follow-up interval?
4. Discussion
Role of Funding Source
Conflict of interest
Acknowledgements
References
Table 1.
Lifetime prevalence of smoking, nicotine dependence and suicidality at baseline (N = 3021)
The gender difference is significant at p < .05. Asterisks indicate the group with the higher rate. Odds Ratios females versus males are for suicide ideation OR = 1.6; 95% CI = 1.2–2.0; for suicide attempts OR = 2.3; 95% CI = 1.3–4.1; for occasional smoking OR = 0.6; 95% CI = 0.5–0.8; for non-dependent regular smoking OR = 0.9; 95% CI = 0.7–1.2; and for dependent regular smoking OR = 0.9; 95% CI = 0.7–1.2.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Among the N = 2222 respondents with at least occasional use, N = 7 used exclusively tobacco products other than cigarettes.d Smoked cigarettes daily for at least for weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.e Smoked cigarettes daily for at least for weeks in lifetime and fulfill DSM-IV criteria for nicotine dependence.f Excludes suicide attempt(s).

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Table 2.
Baseline associations between smoking status and suicidaliy (N = 3021)
N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval.
The odds ratio is significant p < .05; all odds ratios are controlled for age and gender, alcohol and drug use.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Smoked cigarettes daily for at least four weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.d Smoked cigarettes daily for at least four weeks in lifetime and fulfilled DSM-IV criteria for nicotine dependence.e Excludes suicide attempt(s).

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Table 3.
Association between smoking status baseline and new onset of suicide ideation during the four year follow-up period
N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval:
All analyses were controlled for drug and alcohol use.
The odds ratio is significant p < .05; all odds ratios are controlled for age and gender, alcohol and drug use. N = 23 reported attempts.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Smoked cigarettes daily for at least four weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.d Smoked cigarettes daily for at least four weeks in lifetime and fulfilled DSM-IV criteria for nicotine dependence.

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Table 4.
Associations between smoking status baseline and new onset of suicide attempts during the four year follow-up period
N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval:
All analyses were controlled for suicide ideation at baseline as well as for drug and alcohol use.
The odds ratio is significant p < .05; all odds ratios are controlled for age and gender and alc and drug use.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Smoked cigarettes daily for at least four weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.d Smoked cigarettes daily for at least four weeks in lifetime and fulfilled DSM-IV criteria for nicotine dependence.

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Table 5.
Associations between suicide ideation/attempt(s) at baseline and incident smoking during the four-year follow-up
N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval; all odds ratios are controlled for age and gender and occasional smoking at baseline.

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Journal of Affective DisordersVolume 108, Issues 1-2, May 2008, Pages 135-145

Prometa Drug Court Program Shut Down in Washington State-1/11/2008

Prometa Drug Court Program Shut Down in Wash. January 11, 2008
(http://www.msnbc.msn.com/id/22315918/)

A controversial program in Pierce County, Wash., that referred drug-court offenders to the Prometa treatment regimen has been shut down over concerns that claims of treatment success had been exaggerated, MSNBC reported Jan. 11.For example, program officials didn't account for no-shows and dropouts, and declared patients "drug free" simply if they did not test positive for drugs in the 60 days prior to the end of the program.County officials last year approved an $800,000 treatment program focused on the Prometa drug cocktail of gabapentin, flumazenil and hydroxyzine, which owner Hythiam Inc. has touted as an effective treatment for methamphetamine and cocaine addiction. The Pierce County program has since been widely cited by Hythiam as proof of the program's legitimacy.In the wake of the county's decision to pull the program's funding, Hythiam's stock fell from more than $8 a share in October to $2.75 per share this week. The company licenses doctors to deliver Prometa to patients, who pay up to $15,000 for the treatment. Prometa has not been approved by the Food and Drug Administration as an anti-addiction drug, however. And an audit in Piece County found that Hythiam and the Pierce County Alliance, which administered the drug-court program, had "greatly exaggerated" Prometa's success rate. "It's clear to me that we are much more involved in a marketing scheme … rather than testing real results," said Pierce County Councilman Shawn Bunney.Hythiam and Pierce County Alliance officials disagreed, saying the program's effectiveness will be demonstrated when research is published later this year. "The people who are using it -- the doctors, patients, administrators, and drug court judges -- are seeing an impact with it, so I think the treatment will carry it at the end of the day," said Hythiam Executive Vice President Richard Anderson."There were some who did well with Prometa, though they had some positive (urinalysis) after receiving treatment," said James Boyle, deputy director of the Pierce County Alliance. "The auditors view those folks as not being successful. What we were trying to explain to them was that not every person who enters chemical dependency treatment will be drug free from Day One. … It's a process over time."Among those promoting Prometa on a national level are Andrea Grubb Barthwell, a former deputy director at the Office of National Drug Control Policy, and retired Judge Karen Freeman-Wilson, former CEO of the nonprofit National Association of Drug Court Professionals (NADCP), who both serve on the company's board of directors.However, current NADCP CEO West Huddleston has refused to accept Hythiam as a corporate sponsor until the company produces more scientific evident to support its claims about Prometa.

Notable Quotes from NIDA Notes - Current Background Materials and References

Impacts of Drugs on Neurotransmission Vol. 21, No. 4 (October 2007)
The defining features of drug intoxication and addiction can be traced to disruptions in cell-to-cell signaling. http://www.nida.nih.gov/NIDA_notes/NNvol21N4/Impacts.html

Animal Experiments In Addiction Science Reference Article Vol. 20, No. 5 (April 2006)
To learn how drugs promote abuse and produce addiction, researchers focus on animal behaviors that parallel human drug-related behaviors. http://www.nida.nih.gov/NIDA_notes/NNvol20N5/Reference.html

The Basics of Brain Imaging
http://www.nida.nih.gov/NIDA_Notes/NNVol11N5/Basics.html

Cost-Benefit/Cost-Effectiveness Research of Drug Abuse Prevention: Implications for Programming and Policy NIDA Research Monograph, Number 176 [Printed in 1998] http://www.nida.nih.gov/pdf/monographs/monograph176/download176.html

Ethnic Identification and Cultural Ties May Help Prevent Drug Use http://www.nida.nih.gov/NIDA_Notes/NNVol14N3/Ethnic.html

What Are Club Drugs? http://www.nida.nih.gov/NIDA_Notes/NNVol14N6/WhatAre.html

Nicotine Medication Also Reduces Craving in Cocaine Addicts http://www.nida.nih.gov/NIDA_Notes/NNVol15N1/Nicotine.html

Media Guide: Reliable Background for Science Writers http://www.drugabuse.gov/PDF/MediaGuide.pdf

Risk and Protective Factors in Drug Abuse Prevention http://www.nida.nih.gov/NIDA_Notes/NNVol16N6/Risk.html

Childhood Sex Abuse Increases Risk for Drug Dependence in Adult Women http://www.nida.nih.gov/NIDA_Notes/NNVol17N1/Childhood.html

Users Who Develop Drug Dependence During Each Year After First Use http://www.nida.nih.gov/NIDA_notes/NNVol17N4/BBoard.html

Drug Use Associated With More Opportunities to Use, Higher Rates of Acceptance http://www.nida.nih.gov/NIDA_notes/NNVol17N5/Youths.html

Relationships Matter: Impact of Parental, Peer Factors on Teen, Young Adult Substance Abuse http://www.nida.nih.gov/NIDA_notes/NNVol18N2/Relationships.html

Instrument wizard: http://www.instrumentwizard.com/login.asp

On-Site Psychiatric Treatment Improves Abstinence In Teens With Co-occurring Disorders http://www.nida.nih.gov/NIDA_notes/NNvol20N6/Numbers.html

Drug Sniffing Dog