Vol. 129 July 15, 2015 Update on FDA & Sunscreens and Bath Salts

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“Herbal incense” may sound organic,
but it sure ain’t good for you.

 

Sunscreens (1)
Previous blogs have noted that the FDA has limited authority over and regulations for sunscreens, but it does have some. Despite “the common wisdom” that the FDA is slow to approve new prescription drugs, its approval process is generally faster than Europe’s and in 2014 the FDA approved the highest number of new drugs in 18 years – 41 products. (1)

Over-the-counter (OTC) products like sunscreens are regulated by a different process using the standard:  “ generally recognized as safe and effective”. But, in 2014 the FDA declined to permit use of 8 new ingredients in sunscreens even though they have been in use in Europe for 5 years. It cited lack of safety studies, gaps in data, and reports of adverse events. This action prompted an understandable, if   a bit of an over-the-top reaction, from the Wall Street Journal calling to “strip the sunscreen police of all powers over the stuff.”

It is obvious that the FDA has mixed, and unfunded, responsibilities for review of OTC products. A new law, the Sunscreen Innovation Act of 2014 (only in America could we come up with a name like that), tried to clarify the situation, but no new resources were allocated to implement it. In the meantime both the FDA and the CDC continue their efforts to discourage use of tanning beds and promote prevention measures against melanoma which claim 10,000 deaths a year in the U.S.

Synthetic Cannabinoids (SC) (2)

Synthetic cannabinoids (SC) arrived in the U.S. from Europe in 2008 as herbal incense, spice, and bath salts “not for human consumption”. Since 2011 the DEA has placed over 40 SCs into Schedule I of controlled substances which means they are obtainable only by prescription. The problem is that manufacturers of these SCs merely change one or more chemical bonding group or a single chemical chain and the new compound falls outside such a regulation. The compounds are easily obtained on the internet for use in e-cigarettes or are added to energy drinks. They are still labeled “not for human consumption”, and may even carry the assurance that the product “contains no regulated compounds”.

Widespread distribution and marketing have led to recent clusters of serious illness and even deaths, particularly among the young and inexperienced users. Many users reported that they used SCs in order to get high without risking a positive drug test. SCs are NOT detected by the usual urine or blood lab tests, have no available antidote, and can produce serious symptoms which are not readily identifiable as symptoms specific to SC toxicity. Some users have died before reaching an emergency department.

The number of adverse events is increasing. During a two month period in early 2015 Mississippi reported 1200 SC-related visits to the ER and 17 deaths. One reason for this uptick may be the distribution of novel SC compounds that are easily and rapidly synthesized and marketed in response to regulatory actions. They can have new, unknown effects resulting in idiosyncratic toxicity such as delirium, seizures, psychosis, kidney failure, hallucinations, coma, and death.

Ninety-one per cent of users interviewed in one study inhaled vaporized SCs from refillable e-cigarette cartridges. E-cigarettes seem to be garnering more very bad “unintended consequences” than originally predicted by its advocates.

References:
1. NEJM July 9, 2015, pg. 101; A Spotlight on Sunscreen Regulation; J.A. Sharfstein, MD, Johns Hopkins School of Public Health
2. NEJM July 9, 2015, pg. 103, Synthetic Cannabinoids – Related Illnesses and Deaths, DEA, CDC, and University of California

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