Friday, November 16, 2007
11/16/07 - AER on Your Labels?
1. Health Freedom Blog Update, Factoid
2. Best Practices Alert: AER on the label??
3. Evidence based healthcare
4. FDA food safety initiative
5. Healthcare professionals take vitamins!
1. Vitamin Lawyer Health Freedom Blog
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/
Supply Side West – Last week; industry association representative comments on the new AER law: “When questioned on the upcoming adverse events reporting (AER) bill, Seckman [NPA executive director] responded that when the legislation comes into effect at the end of the year, there will be an initial spike in incidences as reporting increases. However, he said this will then stabilize and eventually have a positive effect on the dietary supplement industry's image. "Then we will see that the baseline numbers will be low consistently," said Seckman. "We will then look to publicize this in industry."”
eAlerts - If you are on the Natural Solutions Foundation eAlert list you received an alert early this morning (I thinkwe sent it out about 6 AM…) about my foundation co-trustees, Dr. Laibow and Gen. Stubblebine at the Codex meeting. More about that meeting below. If you want to stay current on health freedom issues, you really need to sign up to the eAlert list - please go to: http://www.globalhealthfreedom.org and sign up today! Better, tell everyone on your elist to do the same! This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact in Washington and internationally. Imagine the impact if the list were One Million Health Freedom Warriors… ready to click their mousse for your right to sell and use high potency products!
2. Best Practices Alert: AER on the label?
I’ve recently seen a few draft labels with statements like “We report all serious adverse events to the FDA.”
Please remove such statements! Mentioning "Adverse Event" might give customers the wrong idea... that they might have an “adverse event” with your product! I have read both the new AER law and the FDA guidance regarding same very carefully (just reread them to be sure) there is NO requirement for any mention of AER on the label!
The law is very specific that filing a serious adverse event report is not an admission of responsibility, but, if you mention AERs on your label, aren’t you admitting that you are selling a product that might harm a customer?
All the law does require is that you to have your company name and an address or phone number on the label. If The Vitamin Lawyer Consultancy reviews your labels, you know they will comply. For more information about the new AER law that goes into effect on December 22, 2007, please see: www.aer-consultants.com
3. Evidence based healthcare
From Answer.com - answers.com/topic/evidence-based-practice
Evidence based practice (EBP) is an approach to care wherein professionals use the best evidence possible, i.e. the most appropriate information available, to make clinical decisions for individual patients. EBP promotes the collection, interpretation, and integration of valid, important and applicable patient-reported, clinician-observed, and research-derived evidence. The best available evidence, moderated by patient circumstances and preferences, is applied to improve the quality of clinical judgments and facilitate cost-effective care.
This involves complex and conscientious decision-making based not only on the available evidence but also on patient characteristics, situations, and preferences. It recognizes that care is individualized and ever changing and involves uncertainties and probabilities. Ultimately EBP is the formalization of the care process that the best clinicians have practiced for generations – from the country “Doc” who knew his patients to the practitioner who knew his patients over decades.
Evidence-based practice (EBP) develops individualized guidelines of best practices to inform the improvement of whatever professional task is at hand. Evidence-based practice is a philosophical approach that is in opposition to rules of thumb, folklore, and tradition. Examples of a reliance on "the way it was always done" can be found in almost every profession, even when those practices are contradicted by new and better information.
Evidence-based design and development decisions are made after reviewing information from repeated rigorous data gathering instead of relying on rules, single observations, or custom. Evidence-based medicine and evidence-based nursing practice are the two largest fields employing this approach. In psychiatry and community mental health, evidence-based practice guides have been created by such organizations as the Substance Abuse and Mental Health Services Administration and the Robert Wood Johnson Foundation, in conjunction with the National Alliance on Mental Illness.
This model of care has been studied for 30 year in universities and is gradually making its way into the public sector. It effectively moves away from the old “medical model” (You have a disease, take this pill.) to a “evidence presented model” using the patient as the starting point in diagnosis. EPBs are being employed in the fields of health care, juvenile justice, mental health and social services among others.
Key elements in using the best evidence to guide the practice of any professional include the development of questions using research-based evidence, the level and types of evidence to be used, and the assessment of effectiveness after completing the task or effort. One obvious problem with EBP in any field is the use of poor quality, contradictory, or incomplete evidence. Evidence-based practice continues to be a developing body of work for professions as diverse as education, psychology, economics, social work and architecture.
According to Norcross et al (2006) "the burgeoning evidence based practice movement in mental health attempts to identity, implement, and disseminate treatments that have been proven demonstrably effective according to the empirical evidence". However, Norcross et al (2006) also state that perhaps it is more useful to identify what does not work - discredited psychological treatments and tests, and has conducted survey research on discredited psychological treatments. Examples of discredited psychotherapies include: the use of pyramid structures, orgone therapy, crystal healing, past lives therapy, chiropractic manipulation, neurolinguistic programming and Erhard Seminars Training.
4. FDA food safety initiative
HHS Unveils Plan to Strengthen, Update Food Safety Efforts
Plan uses integrated collaborative approach to meet demands of a global economy to protect American consumers
HHS Secretary Mike Leavitt today announced a comprehensive initiative by the Food and Drug Administration designed to bolster efforts to better protect the nation's food supply. The Food Protection Plan proposes the use of science and a risk-based approach to ensure the safety of domestic and imported foods eaten by American consumers.
"America's food supply is among the safest in the world, and we enjoy unprecedented choice and convenience in filling the cupboard. Yet, we face new challenges to meet both the changing demands of a global economy and consumers' expectations," Secretary Leavitt said. "This Food Protection Plan will implement a strategy of prevention, intervention and response to build safety into every step of the food supply chain."
HHS Deputy Secretary Tevi Troy and FDA Commissioner Andrew von Eschenbach, M.D., presented the Food Protection Plan at a press conference in Washington, D.C.
"FDA must keep pace with this transformation so that the safety of the nation's food supply remains second to none," said Commissioner von Eschenbach. "The Food Protection Plan calls for effective action before an outbreak occurs."
The Food Protection Plan, which focuses on both domestic and imported food, complements the Import Safety Action Plan delivered by Secretary Leavitt to the President earlier today that recommends how the U.S. can improve the safety of all imported products. This year, $2 trillion worth of goods will be imported into the U.S., and experts predict that amount will triple by 2015. The Import Safety Action Plan lays out a road map with short- and long-term recommendations to enhance product safety at every step of the import life cycle. Taken together, the two plans will improve efforts by the public and private sector to enhance the safety of a wide array of products used by American consumers.
Advances in food production technology, rapid methods of food distribution, and globalization have transformed supermarket shelves and restaurant menus, broadened the tastes of consumers, and challenged the existing food protection framework.
"Although our agency clearly needs to maintain and enhance its response capacity, the primary goal is to prevent contaminated food from ever reaching the consumer," said von Eschenbach.
The plan is premised on preventing harm before it can occur, intervening at key points in the food production system, and responding immediately when problems are identified. Within these three overarching areas of protection, the plan contains a number of action steps as well as a set of legislative proposals. Taken together, these efforts will provide a food protection framework that ensures that the U.S. food supply remains safe.
To strengthen its efforts to prevent contamination, FDA plans to strengthen support of food industry efforts to build safety into products manufactured either domestically or imported. The FDA will work with industry, state, local, and foreign governments to identify vulnerabilities and will look to industry to mitigate those vulnerabilities, using effective methods such as preventive controls.
The plan's intervention element emphasizes focusing inspections and sampling based on risk at the manufacturer and processor level, for both domestic and imported products, that will help verify the preventive controls. This approach is complemented by targeted, risk-based inspections at the points where foreign food products enter the United States, including ports.
The plan calls for enhancing FDA's information systems related to both domestic and imported foods to better respond to food safety threats and communicate during an emergency.
The Food Protection Plan's three core elements--prevention, intervention, and response--incorporate four cross-cutting principles for comprehensive food protection along the entire production chain:
* Focus on risks over a product's life cycle from production to consumption;
* Target resources to achieve greatest risk reduction;
* Use interventions that address both food safety (unintentional contamination) and food defense (deliberate contamination); and
* Use science and employ modern technology, including enhanced information technology systems.
The Food Protection Plan is available at fda.gov/oc/initiatives/advance/food/plan.html.
5. Healthcare professionals take vitamins!
The Council for Responsible Nutrition (CRN) has announced as part of the initial results from its survey of healthcare professionals that, contrary to industry belief, the sector is in fact both using and recommending dietary supplements.
"It reconfirms what we know: that supplements are very mainstream in the US," CRN vice president of communications Judy Blatman told NutraIngredients-USA. Industry repeatedly claims there is a perceived divide between its products and so-called mainstream medicine - but Blatman says this may not even be as prevalent as once thought and that the key now is to get healthcare professionals to talk more to their patients about the potential benefits of these products.
"We need to make sure that we as an industry are communicating with healthcare professionals and that they are communicating with their patients and getting accurate information," said Blatman… Perhaps even more surprising is that not only did the survey reveal that 72 percent of physicians use supplements… 85 percent recommend them to their patients…”