Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements

 

Dietary supplements (Photo credit: Andrei Z)

 

From the 2 October 2012 report by the Office of the Inspector General, US Department of Health and Human Services

 

Summary

WHY WE DID THIS STUDY

The Government Accountability Office and public interest groups have raised concerns about a specific type of claim-called a structure/function claim-that manufacturers may use on dietary supplement labels. Manufacturers have used these claims to promote health benefits of their products. Stakeholders have urged FDA to strengthen oversight of these claims because they are potentially misleading and may lack scientific support. FDA lacks authority to review or approve these claims before products enter the market. Manufacturers must have competent and reliable scientific evidence to show that claims are truthful and not misleading, but they do not have to submit the substantiation to FDA, and FDA has only voluntary standards for it. A manufacturer must notify FDA when it uses structure/function claims, and a product label must include a disclaimer stating that FDA has not reviewed the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.

HOW WE DID THIS STUDY

We analyzed structure/function claims for a purposive sample of 127 dietary supplements marketed for weight loss or immune system support. We reviewed the claims to determine the extent to which they complied with FDA regulations. We reviewed substantiation provided by manufacturers to describe the quantity and nature of the evidence. We also assessed the accuracy and completeness of notification letters that manufacturers must submit to FDA for their structure/function claims.

WHAT WE FOUND

Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence. FDA could not readily determine whether manufacturers had submitted the required notification for their claims. Seven percent of the supplements lacked the required disclaimer, and 20 percent included prohibited disease claims on their labels. These results raise questions about the extent to which structure/function claims are truthful and not misleading.

WHAT WE RECOMMEND

We recommend that FDA seek explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading. We recommend that FDA improve the notification system for these claims to make it more organized, complete, and accurate. We also recommend that FDA expand market surveillance to enforce the use of disclaimers for structure/function claims and to detect disease claims. In its comments on the draft report, FDA did not explicitly concur with our first recommendation, but said it would consider it. FDA concurred with our second and third recommendations.

 

Related articles

• CRN Responds To Today’s Dietary Supplement Reports From Health And Human Services (sacbee.com)
• Report: Some dietary supplements illegally labeled (seattlepi.com)
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• Report: Some Dietary Supplements Illegally Labeled (sanfrancisco.cbslocal.com)

 

Off-Label Drug Use Common, but Patients May Not Know They’re Taking Them

 

From the 6 August 2012 article at Science News Daily

Many people have probably heard of off-label drug use, but they may not know when that applies to prescriptions they are taking, a Mayo Clinic analysis found. Off-label drug use occurs when a physician prescribes medication to treat a condition before that use has been approved by the Food and Drug Administration.

In a newly published article in Mayo Clinic Proceedings, researchers pose and answer 10 questions about off-label drug use.

“Since the Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common,” says lead author Christopher Wittich, M.D., internal medicine physician at Mayo Clinic. “Health care providers and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one.”

Some highlights from the article:

* Off-label drug use is common. Within a group of commonly used medications, roughly 1 in 5 prescriptions were for an off-label use, a 2006 report found. Another study found that about 79 percent of children discharged from pediatric hospitals were taking at least one off-label medication.

* Patients may not know when drugs they have been prescribed are being used off-label. No court decision has required that physicians must disclose, through informed consent, the off-label use of a drug, the authors say. The FDA makes clear that it doesn’t regulate the practice of medicine and that the federal Food, Drug, and Cosmetic Act of 1938 doesn’t make physicians liable for off-label drug use, they note.

* Off-label drug use can become the predominant treatment for a condition. For example, some antidepressants are not approved by the FDA as a treatment for neuropathic pain, yet some drugs in this class are considered a first-line treatment option.

* Examples of widely practiced off-label drug use include morphine, used extensively to treat pain in hospitalized pediatric patients. Many inhaled bronchodilators, antimicrobials, anticonvulsants, and proton pump inhibitors also are used in children without formal FDA approval.

* Obtaining new FDA approval for a medication can be costly and time-consuming. To add additional indications for an already approved medication requires a supplemental drug application; if eventually approved, revenue from it may not offset the expense and effort for obtaining approval.

* Generic medications may not have the requisite funding resources needed to pursue FDA-approval studies. For these financial reasons, drug proprietors may never seek FDA approval for a new drug indication.

* Pharmaceutical manufacturers are not allowed to promote off-label uses of medications. However, they can respond to unsolicited questions from health care providers and distribute peer-reviewed publications about off-label use. Just this year, GlaxoSmithKline agreed to pay a record $3 billion to settle a Justice Department case involving alleged off-label drug use marketing, and Merck Sharp & Dohme was fined $322 million over its alleged promotion of the painkiller Vioxx for an off-label use.

 

Related articles

• Disclosure Not Necessary For Off-Label Drug Use; Patients May Not Know They’re Taking Them (medicalnewstoday.com)
• Many People Not Aware Of Their Off-Label Drug Use (medicalnewstoday.com)
• Off-label drug use common, but patients may not know they’re taking them, Mayo finds (eurekalert.org)
• Off-label drug use common, but patients may not know they’re taking them, study finds (medicalxpress.com)
• Off-Label Drug Disclosure Inadequate (the-scientist.com)
• Doctors Petition F.D.A. for Painkiller Limits (nytimes.com)
• Off-Label Use of Rx Drugs Legal, Controversial (blogs.lawyers.com)
• OxyContin: Painkillers for Kids (zen-haven.dk)

 

Move for Food Freedom!

Reblogged from A Mover's Blog:

• 
• 

"Food Safety Now!"

Who wouldn’t rally behind such a cause?

This has been the battle cry of those in the uppermost echelons of our food regulatory bodies and public health departments for years now. With each widely-publicized food-borne disease outbreak comes more proposed controls on who, where, when, why and how we can put food on our tables. With such names as The Food Safety Modernization Act, it's hard to argue against the proposals...at least until you peel away the layers.

Read more… 497 more words

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• The Food Safety Modernization Act (foodservicewarehouse.com)

Database Is One-Stop Resource on Kids’ Medications

From an FDA Consumer Update

When adults are advised by their health care professional to use a medication, they expect to receive information—backed up by data from studies—on the correct and safe dose to take. For drugs used in children, this information may not be available because historically not all products are studied in children.

To fix this situation, Congress passed legislation to increase pediatric studies and incorporate the resulting information in labeling. This is a key point because medicines often affect children differently from the way they work in adults.

The Food and Drug Administration (FDA) has been working hard on this project. To make it easier for parents and health care professionals to find information on pediatric medications, the FDA created a database that covers medical products studied in children under recent pediatric legislation.

The Pediatric Labeling Information Database is a one-stop resource. You can search for information by the product’s commercial or chemical name, or by the condition for which it was studied. FDA’s Office of Pediatric Therapeutics (OPT), which focuses on safety, scientific, and ethical issues that arise in pediatric clinical trials or after products are approved for use in children, developed the tool in collaboration with another branch of the agency, the Center for Drug Evaluation and Research.

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ritalin (Photo credit: Wikipedia)

From the summary at Full Text Reports (May 5, 2012)

Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Source:  Institute of Medicine
In any given month, an estimated 48 percent of Americans take at least one prescription drug. Prescription drugs are crucial for preventing and treating diseases and improving the public’s health, but they can also have unintended harmful effects. Often, their benefits and risks cannot be fully identified until after a drug has been used by a large, diverse group of patients over time, mainly because clinical trials conducted before approval may be too small or too short to detect all possible risks. The passage of the Food and Drug Administration Act in 2007 provides the Food and Drug Administration (FDA) with additional postmarketing regulatory tools to better protect the health of the public, including the authority to require manufacturers to continue studying drugs that are being marketed.
To help determine when it is appropriate to require a postmarketing study, which types of studies to require, how to best protect the rights and interests of patients who participate in research, and how to use research in making regulatory decisions, the FDA asked the IOM to evaluate the scientific and ethical aspects of conducting safety studies for approved drugs. The IOM concludes that the FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle. Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision-making process more predictable, transparent, and proactive. These changes could allow the FDA to better anticipate post-approval research needs and improve drug safety for all Americans.

The free full text report is at http://www.iom.edu/Reports/2012/Ethical-and-Scientific-Issues-in-Studying-the-Safety-of-Approved-Drugs.aspx

Related articles

• Ethical and Scientific Issues in Studying the Safety of Approved Drugs (bespacific.com)
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Fatal Attraction: Cosmetics and Chemicals

This item came to me this morning by Jenica Rhee (Twitter – @jenicarhee), who has emailed me links in the past few months to infographics she created (How Bikes can Save Us and Soda’s Evil Twin).
A quick glance at the references shows a great selection of resources from reputable organizations.

It is heartening to see a cosmetology school take a strong stand on regulating chemicals in cosmetics.

Chemicals in Cosmetics and on Your Face

Click here to see the graphic!

Scientists are talking about it; angry people are talking about it. The United States Food and Drug Administration is the government regulator of things like vaccines and pharmaceutical drugs, but when it comes to cosmetics (the topical stuff you put on your body like lotions, deodorant, and make-up) there seems to be a disconnect. The FDA only regulates the labeling of cosmetics, but the public safety of the chemicals in those products is assessed by the  ”Cosmetic Ingredient Review” — which is funded by the industry. Go figure.

The graphic outlines various studies that have cropped up over time regarding potential connections between hazardous chemicals and contamination of Americans, whose cosmetic regulatory polices lag far behind places like Europe and Canada. Take a look at some of the stuff that’s hiding in your daily routine — you might never shampoo your hair ever again.

• Scientists are talking about it; angry people are talking about it. The United States Food and Drug Administration is the government regulator of things like vaccines and pharmaceutical drugs, but when it comes to cosmetics (the topical stuff you put on your body like lotions, deodorant, and make-up) there seems to be a disconnect. The FDA only regulates the labeling of cosmetics, but the public safety of the chemicals in those products is assessed by the  ”Cosmetic Ingredient Review” — which is funded by the industry. Go figure.The graphic outlines various studies that have cropped up over time regarding potential connections between hazardous chemicals and contamination of Americans, whose cosmetic regulatory polices lag far behind places like Europe and Canada. Take a look at some of the stuff that’s hiding in your daily routine — you might never shampoo your hair ever again.

From the link at  Chemicals in Cosmetics and on Your Face

Scientists are talking about it; angry people are talking about it. The United States Food and Drug Administration is the government regulator of things like vaccines and pharmaceutical drugs, but when it comes to cosmetics (the topical stuff you put on your body like lotions, deodorant, and make-up) there seems to be a disconnect. The FDA only regulates the labeling of cosmetics, but the public safety of the chemicals in those products is assessed by the  ”Cosmetic Ingredient Review” — which is funded by the industry. Go figure.

The graphic outlines various studies that have cropped up over time regarding potential connections between hazardous chemicals and contamination of Americans, whose cosmetic regulatory polices lag far behind places like Europe and Canada. Take a look at some of the stuff that’s hiding in your daily routine — you might never shampoo your hair ever again.

Related articles

• Fatal Attraction: Cosmetics and Chemicals (simplegreenorganichappy.com)
• Do You Worry About Chemicals in Your Makeup? (bellasugar.com)
• Cracking Down on Toxic Makeup (ecocentric.blogs.time.com)
• Toxic Cosmetics: Is More Regulation Needed? (abcnews.go.com)
• What You Need To Know About Beauty Product Safety (self.com)
• Cosmetics Bill Seeks Full Ingredient Disclosure, FDA Oversight (greenbiz.com)
• Beauty Byte: Cosmetics Labels Are About to Bug Out (bellasugar.com)
• The FDA Is Cracking Down on Cosmetics Claims (bellasugar.com)
• Beauty Byte: Consumer Group Questions Carcinogenic Chemicals in Johnson & Johnson Products (bellasugar.com)
• Cosmetics and Contraversy (drerindenil.wordpress.com)
• Fatal Attraction (hartlove.wordpress.com)

Warning! Ads and popups at inspiredm.com, still…the listings of infographics is a good find…so use your judgement before clicking on the link below

• Infographics of the Week #22 (inspiredm.com)

Communicating Health Risk Is A Risky Task For FDA

 

Image via Wikipedia

Communicating Health Risk Is A Risky Task For FDA

From the 23 January Medical News Today article

The impact of efforts by the U.S. Food and Drug Administration to notify the general public and health care providers about unanticipated risks from approved medications has been “varied and unpredictable,” according to a systematic review of published studies about FDA warnings and alerts over the last 20 years.

Although some communication efforts had a strong and immediate effect, many had little or no impact on drug use or health behaviors and several had unintended consequences, researchers report in the journal Medical Care. …

…The FDA has several standard tools to disseminate new evidence about drug safety. These include “Dear Healthcare Provider” letters to prescribers*, “public health advisories” and “Safety Alerts” targeting the general public, and “black box warnings”** added to a label when a drug’s risks may be particularly severe or affect a large population. Despite numerous studies examining single alerts, advisories and label changes, no prior study has systematically examined the effect of these risk communications….

[Article summarizes the effectiveness of 4 categories of communication]

…Part of the problem, the authors emphasize, is the challenge of communicating complex risk messages to a large, diverse audience. “The most effective communications were the simplest, those that were specific, where alternatives were available, and where the messaging was reinforced over time,” said Stacie Dusetzina, PhD, lead author from Harvard Medical School.

 

Read the entire Medical News Today article

*No direct links to “Dear Healthcare Provider” letters at http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/default.htm
However, individual letters can be found through using search engines, as a recent one for the drug Promacta

**Recent black box warnings are listed at Drug Safety Communications . If a drug has a black box warning, it will be part of its label. Drug information by name of drug is located at Drugs@FDA.

Related articles

• Beauty Byte: FDA Orders “Black Box” Warning For Botox (bellasugar.com)
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MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Concerned about the safety of your drugs or medical advices? Wish to report a serious medical product problem online?
The US Food and Drug Agency (FDA) can help.

Medwatch is the FDA gateway for clinically important safety information and reporting serious problems with human medical products.

Safety Information includes

• DailyMed (National Library of Medicine)
  Current Drug Prescribing Information
• Medication Guides
• Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)
• Postmarketing Drug and Biologic Safety Evaluations
  Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.
• Current Drug Shortages
  
• Recalls and Alerts
  • MedWatch Safety Alerts for Human Medical Products
  • FDA Patient Safety News Video Broadcasts
  • FDA Drug Safety Newsletter

Medwatch also encourages anyone to report serious problems with human medical products

• Report a Serious Medical Product Problem Online
• Reporting Unlawful Sales of Medical Products on the Internet
  

Want to stay informed with MedWatch updates? Here are some options…

Stay Informed

• Subscribe to MedWatch Safety Alerts
• Join the MedWatch E-list
• About the MedWatch E-list
• Follow MedWatch on Twitter
• MedWatch Safety Alerts RSS Feed
• RSS News Feed Help

Related Resource

Track medication safety from your iPhone

Now available for free in the iTunes store!

Stay up to date with the latest news and government safety alerts for the prescription medicines you take. Submit any side effects you experience to the US Food and Drug Administration (FDA) to make drugs safer for everyone.

MedWatcher is a mobile tool for both healthcare professionals and the general public.

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A Better FDA? Why Not? « GxP Perspectives

 

Image via Wikipedia

A Better FDA? Why Not?  [From the December 2011 GxP Perspectives Blog]

Is FDA necessary? Most people I know would say yes. We need a strong, independent, effective FDA. Does FDA need improvements? Again, most people I know can point to numerous issues that FDA could handle better. Today, in the Business Section of the New York Times, there is an article on why we need government and the benefits of better government. Yes, the article by Robert H. Frank is about the Tompkins County New York Department of Moter Vehicles, but he outlines some basic principles for better government. Like better use of technology to make government more efficient. FDA is making similar efforts regarding technology. That’s great and I encourage the development. Here are three other areas that I think that FDA can improve:

1. Consistent training for field investigators….

Click here to read the entire blog item

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Fish Hazards and Controls: More Than a Fish Story

From the FDA Web page

The Hazards Guide is a roadmap for commercial fishermen and processors to follow to ensure that consumers don’t become ill from parasites, pathogens (bacteria, viruses, fungi), or natural toxins (poisonous substances produced by living organisms) in the seafood they eat.

In April 2011, FDA released the fourth edition of the Hazards Guide and posted on the FDA website an introductory video to the guide for the seafood industry.

The Hazards Guide gives fishermen and seafood processors the latest scientific information on contaminants that can be present in their products and where they need controls to eliminate them.

For example, research conducted by FDA gave the agency new insights on what was needed to control scombrotoxin in the processing of tuna and mahi-mahi. Scombrotoxin is one of the most common causes of fish-related “food poisoning” in the U.S….

Related Resources

• Fresh and Frozen Seafood: Selecting and Serving it Safely
• Fish and Fishery Products Hazards and Controls Guidance
• Cooperative Program Ensures Safe Shellfish (slideshow)
• Cooperative Program Ensures Safe Shellfish (Consumer Update)

Related articles

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• NYT: Something fishy about seafood labels (msnbc.msn.com)
• Tests Reveal Mislabeling of Fish (nytimes.com)