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

 

Dietary supplements

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.

 

 

October 4, 2012 Posted by | Nutrition | , , , , | 2 Comments

American Medical Association (AMA) news: Appealing denied claims seems to work, GAO report says :: April 11, 2011 … American Medical News

amednews: Appealing denied claims seems to work, GAO report says :: April 11, 2011 … American Medical News

Yes, this is old news, but thought it would be worth posting…

The government is looking for a way to track and report denial rates to consumers as part of health insurance exchanges.

By EMILY BERRY, amednews staff. Posted April 11, 2011.

  • A government review of the rates at which insurers decline to write policies and reject claims for payment found that when physicians and patients appealed denied claims, those appeals were “frequently” successful, with 39% to 59% resulting in a reversal.

The Government Accountability Office report, released March 16, also found that many health insurance claims denials stem from miscodings, incomplete information or other paperwork errors, pointing to the need for further automation of claims processing.

The report examined what the GAO called “application denials” — declining to write a policy for someone — as well as “coverage denials” — deciding not to pay a claim. The Patient Protection and Affordable Care Act called on the GAO to examine both. The Dept. of Health and Human Services, which has started tracking application denials, plans to track and publish rates of coverage denials as part of the health insurance exchanges that will be part of the health reform law, according to the report.

Until HHS tracks application and coverage denials in a comprehensive way, there is limited information available about both. The GAO noted that the American Medical Association helped the authors interpret and understand the limitations of denial data available.

Rejected applications, denied claims

The GAO examined application denial data in the individual insurance market, collected by the HHS during the first quarter of 2010 and from six states that already track denials.

Researchers found that the rate at which insurers declined to offer an applicant coverage averaged 19%, but rates varied widely……

February 13, 2012 Posted by | health care | , , , , , , | Leave a comment

   

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