FDA

The Food and Drug Administration (FDA) makes it clear that their regulations on our foods, drugs, cosmetics, etc. are not created in a vacuum, rather they are "formed with the public’s help."

The mainstay of this public interaction is through providing an open comment period. The FDA states, "By law, anyone can participate in the rule-making process by commenting in writing. FDA routinely allows plenty of time for public input (typically 60 days) and carefully considers these comments when it draws up a final rule." 

But, who are the "public" that provide comments on these issues?

From the looks of it - not scientists. 

One month ago, we wrote a story "...

The controversy over Genetically Modified Organisms (GMOs) lives on, despite the scientific community's best efforts to quell the scaremongering.    

In fact, GMOs are the scientific issue with the widest gap in understanding between scientists and the public, with 88% of scientists reporting that GMOs are safe to eat, as compared to just 37% of the public. One of the reasons for that gap is that scientists understand the biology behind how GMOs are created and why they are not harmful. But, lacking that understanding leaves a lot of space for fear and uncertainty.  

Even worse, as GMOs become even more complicated, the gap in understanding is bound to get larger.

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The case that links homeopathic teething remedies to the deaths of 10 infants got a little stronger last week when The US Food and Drug Administration (FDA) released new information from their ongoing investigation. 

The FDA confirmed, through its analysis, the presence of the poisonous substance belladonna in the teething remedies. More importantly, their analysis detected amounts that were inconsistent between samples, and some of the levels were much higher than that indicated on the labeling of the product. 

Although the FDA has been warning for years to stay away from these teething remedies, the...

Co-Authored By Pamela Paresky, Ph.D.

The U.S. Food and Drug Administration (FDA) recently advised parents to stop using and immediately discard certain homeopathic teething products for infants because they contain belladonna, a toxic chemical in amounts that cannot be verified as safe. To medical professionals, this is no surprise. Despite the fact that many natural products contain harmful ingredients, the FDA has been playing catch-up ever since these “non-medical” products began to saturate the market after the Dietary Supplement Health and Education Act of 1994 was passed over the protests of the medical community, and allowed sale of almost anything with...

I was blind, but now I see.  

I read an article by an economics student where the author suggests Johnson & Johnson and new contact lens legislation are teaming up to deprive consumers of choice and the ability to get their contact lenses.

Relax, the free market is safe and optometrists are also not in cahoots with ophthalmologists (nor are they the same). 

Let’s break it down, as I underscore the importance of not being so readily convinced by everything you read.  In 2004, The Fairness to Contact Lens Consumers Act passed.  In summary, it insisted prescribers give patients copies of their contact lens prescriptions so they can...

Heparin. (Credit: LHcheM/Wikipedia) Heparin. (Credit: LHcheM/Wikipedia)

I never cease to be amazed by the crazy things that otherwise intelligent people are willing to believe. Two years ago, Newsweek ran a cover story titled "The Plots to Destroy America," which described the troubling beliefs -- from 9/11 trutherism to Obama birtherism -- held by so many of our fellow compatriots. The author worries that...

 

shutterstock_148284839 Sugar Cane in the Field via Shutterstock

For years the public has been advised that sugar is bad — and to minimize its consumption. This presents a problem for the food industry which adds sugar (and here I mean sucrose or table sugar) to a myriad of products. Even foods that you don't think of as sweet, such as ketchup, contain sugar. So how does the industry, which is required to list a product's ingredients on the label, deal with the problem of admitting they add a "bad" ingredient to their products? By...

FDA Stamp of ApprovalEarlier this month, the results of an investigation of the FDA by the federal General Accountability Office (GAO) were reported, and the agency is likely to be embarrassed by its findings. Under the rubric Drug Safety, the report was entitled "FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement."

Beginning in 2003, the FDA set about establishing pathways for expedited reviews for new drug applications in certain categories where it was felt that the standard, multi-year process was too...

BloodAt last, the FDA has decided to drop one of its shoes by allowing men who have sex with men to donate blood that is if they've abstained from this practice for the entire year before the donation.

This change in official government policy is based on solid scientific evidence, and is surely a major advance, as compared to 1983's total ban on such donations. But is it still too stringent, particularly as we face frequent blood shortages?

One the one hand, the FDA's studies and procedures have led to a risk of...

Back in 2008, Congress passed a law requiring all those administering clinical trials governmental agencies, nonprofits and academic institutions and private companies to submit complete data from each trial to the clinicaltrials.gov. A main impetus for codifying submission to the website was to add extra levels of...