The tragic death of Lori McClintock, the wife of California Republican Congressman Tom McClintock, is being used as a justification for additional supplement requirements. Here’s why these arguments are misguided. Action Alert!
Almost every major news outlet jumped on the story: “Death of Congressman’s wife linked to ‘white mulberry leaf ingestion’ – coroner” reports The Guardian. “Death of Rep. Tom McClintock’s Wife Tied to White Mulberry Leaf,” reads the New York Times’ headline. Both articles then use the opportunity to claim that supplements are unregulated and plug Senator Dick Durbin’s “mandatory product listing” policy we’ve written so much about. There is no question that the death of Lori McClintock is tragic; the argument that her death proves that supplements need more regulation is, however, completely unjustified.
First, white mulberry leaf as an herb appears to be generally safe—which has been noted in at least some of the news coverage of this sad event. Other studies have similarly concluded that white mulberry leaf extracts can be considered safe. Millions consume white mulberry leaf without experiencing any adverse effects.
What the media are reporting is that McClintock had a “partially intact” white mulberry lead in her stomach, and the cause of death has been attributed to dehydration and gastroenteritis. Attributing her death to the white mulberry leaf is speculative. Botanical safety experts have said that white mulberry leaf “is a very unlikely culprit for a case of severe intestinal inflammation that could lead to fatal dehydration.” It is also strange that a “partially intact” leaf was found, as supplement forms of white mulberry are generally whole leaf powders or powdered extracts contained in capsules; white mulberry leaf teas are available, but those leaves are also generally much smaller. From the information we have, it is impossible to know what product McClintock used, how much, and for how long.
It’s possible that, if McClintock took the white mulberry leaf as a supplement, that it was adulterated with other ingredients that could cause adverse reactions. If that is the case, the FDA has full authority under the law to remove adulterated supplements from the market because supplements are stringently regulated. They must adhere to “current Good Manufacturing Practices” (cGMPS), which establish requirements for manufacturing, packaging, labeling, and holding dietary supplements. This system helps to prevent contamination, deviation, mix-ups, and failures. Standards are set for manufacturing and testing with regard to raw materials, quality assurance, record-keeping, cleanliness and safety, qualifications of manufacturing personnel, product testing, production and process controls, and distribution. There are additional standards for the marketing and labeling of supplements, as well as the registration of facilities producing supplements.
All of this is to say that laws to guarantee safe products are already on the books, and it is up to the FDA to enforce those laws, yet the agency routinely fails to do so. Look no further than the vaping industry. The FDA ordered hundreds of these products off the market, but recent reports show that vaping companies are ignoring the FDA’s orders, and the agency is letting it happen.
In the past, there has been evidence of something even more sinister going on. FDA memos, retrieved through Freedom of Information Act requests, show that the agency has, at least in the past, deliberately refused to enforce laws in the hope that something would occur which was so bad that current supplement law would be abandoned in favor of a drug-type regulation scheme. If once in a great while some bad actors fail to meet the current high standards, and the FDA fails to hold them accountable, this should not reflect on the entire industry. The FDA already has the power it needs, so passing more regulations would simply be redundant.
The testing regimens which the supplement industry are held to under cGMPs are one reason that supplements have such a proven track record of safety—more so than food, not to mention FDA-approved pharmaceuticals. One report from the Government Accountability Office found that there were an average of 1,575 adverse event reports (AERs) related to supplements per year between 2008 and 2011. When you factor in that about half of Americans (157 million people) take supplements every day, this means that only one-hundredth of one percent of all supplement users ever experience any problems at all. It is also worth noting that AERs are not concrete evidence of supplements being a factor in an adverse event, but simply a possible correlation. What supplement adverse events there are tend to be a result of elderly patients or young children choking on pills. Further, analyses by the American Association of Poison Control Center’s National Poison Data System routinely find zero deaths from dietary supplements.
By contrast, in 2014, there were 1,289,133 drug adverse events. Our counterparts at ANH-International found that UK residents were about as likely to get struck by lightning as die from taking dietary supplements.
Put simply, supplements are fully regulated, and the FDA has the power to remove unsafe, adulterated products from the market. Due to these facts, it is rather galling to use a tragic death such as McClintock’s as a means of garnering support for additional supplement regulations that appear to be faltering in Congress. We must not be deterred and continue to pressure Congress NOT to pass mandatory product registration for dietary supplements. As we’ve explained in previous coverage, we believe mandatory product registration is the first step towards restrictions on vitamin doses allowed in supplements; this move also threatens to destroy innovation in the supplement industry, eliminating quality products and leaving us only with the most basic products that make mega-corporations money. We can’t let this happen.
Action Alert! Write to Congress and tell them to oppose mandatory product registration for dietary supplements. Please send your message immediately.