Regulatory & Compliance

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The one red

On Monday, August 3rd, the Food and Drug Administration (FDA) approved the first 3D printed pill, signaling a new opportunity for drug makers and 3D printing technology.

Spritam, a medication for epilepsy, is manufactured by Ohio-based pharmaceutical company, Aprecia Pharmaceuticals.  This particular drug has already been on the market, but the new, 3D printed version, is designed to dissolve more rapidly than any other seizure medication.  This new design also allows for a high drug load to be delivered in a single dose, limiting the number of pills necessary.  The 3D printed design may be particularly helpful for children or other patients who have difficulty swallowing large pills.  By layering medication, 3D printing allows the creation of a more porous pill that can dissolve more quickly into liquid.  The pill should be available commercially early in 2016. …
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Science and Nature

On July 23, 2015, the U.S. House of Representatives passed legislation that would restrict state and local governments from regulating the use of genetically modified (GM) plants in food if that regulation affects interstate commerce.

The bill, H.R. 1599, passed in a 275-150 vote after the bill’s main sponsor, Rep. Mike Pompeo, R-Kan., claimed that the bill is in line with the “overwhelming” scientific evidence on the safety of GM foods.  Specifically, Pompeo said that “[p]recisely zero pieces of credible evidence have been presented that foods produced with biotechnology pose any risk to our health and safety.”  He further stated that “ it is not the place of government — government at any level — to arbitrarily step in and mandate that one plant product should be labeled based solely on how it is bred, while another, identical product is free of government warning labels.”…
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The Consumer Product Safety Commission (CPSC) has responded to the June 27, 2015 PL&MT Blog’s post Falling off the Fast Track: CPSC’s New “Stop Sale” Demand by Jonathan Judge.  The post was republished by the National Law Review and the CPSC’s comments can be found here.  The back-and-forth is very productive and enlightening.  This post contains Jonathan Judge’s reply to the CPSC’s response.…
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When a company sells a consumer product that poses a potential hazard to consumers, federal law requires that a report be filed with the U.S. Consumer Product Safety Commission (CPSC). 15 U.S.C. § 2064(b). Companies who fail to do so risk severe civil penalties. After the company’s report has been filed, the CPSC offers companies one of two tracks: (1) the Standard Track, in which the CPSC (eventually) makes a Preliminary Determination (PD) of whether the product is defective; or (2) the Fast Track, in which the company can request to conduct a recall and, in exchange, the CPSC will refrain from making an official determination of defect and help speed the process along.

For years, the Fast Track process has been a winning formula for CPSC and companies alike. The CPSC saves engineering and bureaucratic resources because it no longer has to conduct a full-blown investigation. Similarly, a company who wants to improve their product and/or protect consumers can launch a national campaign within a few weeks of filing to address problems with the product.…
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Recent reports purport to link certain chemicals used in nail salon products to serious health problems such as cancer, asthma, respiratory disease, and miscarriages.  Though past efforts to impose stricter regulations on these chemicals have been largely unsuccessful, a recent slew of New York Times articles have drawn significant attention to the issue.  In response, New York Governor Andrew Cuomo issued a number of emergency regulations to protect salon workers, and New York City mayor Bill de Blasio has announced his own efforts to address the issue.  These responses could indicate a willingness on the part of lawmakers to revisit the laws regulating the cosmetics industry.…
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The FDA is expected to announce a final rule that could effectively eliminate most trans fat from food in the United States.  In 2013 the FDA announced its preliminary finding that partially hydrogenated oils (PHOs) – – the source of most trans fatty acids in American’s foods – – are not generally recognized as safe (GRAS) for use in any food.  If the FDA makes final its preliminary finding, PHOs will no longer enjoy GRAS status and will be subject to greater scrutiny by the FDA.

The regulation of trans fats can be traced back to 1999 when the FDA first proposed that manufacturers be required to declare the number of grams of trans fat on their nutrition labels.  Due to growing public health concerns, the FDA finalized this rule in 2006.  That rule resulted in reduced amounts of trans fat in food products.  A final rule that strips trans fat of GRAS status would subject food products with trans fat to greater scrutiny and may effectively eliminate all trans fat from those products.…
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Fish oil pills spilled from container split tone

In response to mounting pressure, the FDA issued warnings to five supplement companies last week regarding the risks associated with beta-methylphenethylamine, or BMPEA. BMPEA is widely used in weight loss and energy supplements, but has an ingredient similar to amphetamine.

Supplement makers claimed that BMPEA was allowed in dietary supplements because it occurred naturally in a shrub known as Acacia rigidula. Dr. Pieter Cohen of Harvard University, who has criticized the FDA’s slow action on BMPEA, conducted a study of products listing Acacia rigidula as an ingredient, suspecting it signified the presence of BMPEA.

In its letters to the supplement companies, the FDA stated that it was “aware of no evidence to support an assertion that BMPEA is, in fact, a constituent of this botanical [Acacia rigidula].”

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Last night, Texas-based Blue Bell Creamery announced a full, nationwide recall of all its products. This is a significant expansion of the recall Blue Bell began earlier this month after three deaths in Kansas from listeria – the first recall in the company’s 108-year history. The initial recall was limited to specific products, but was expanded to all products after two samples of cookie dough ice cream tested positive for listeria. The CDC traced the Kansas cases of listeria to Blue Bell plants in Texas and Oklahoma, but it is still not clear how the contamination began.

Listeria monocytogenes can cause severe, sometimes fatal illness in children, elderly people, and people with weakened immune systems. Symptoms include high fever, nausea, abdominal pain, and stiffness. Currently, ten reported listeria cases are linked to Blue Bell. Five people have been diagnosed in Kansas, one in Oklahoma, three in Texas, and today, the CDC announced an Arizona case.

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Whether you’re a bodybuilder trying to lose that last percentage of body fat or an average person looking to lose a few extra pounds, weight loss supplements can offer a quick fix. But a number of popular fat-burning weight loss supplements may contain the chemical known as Beta-methylphenylethylamine (BMPEA), a stimulant recently criticized for its “amphetamine-like” qualities. A recently published study led by Dr. Pieter Cohen of Harvard Medical School found BMPEA in eleven supplements on the shelves at various vitamin or supplement stores.
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The United States Supreme Court has decided not to review Pliva v. Huck, an Iowa Supreme Court decision that held federal law does not preempt failure to update claims against generic drug manufacturers. Pliva challenged the ruling on the ground such claims were covered under the federal preemption memorialized in the 2011 U.S. Supreme Court decision Pliva v. Mensing.…
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