Consumer Reports Gets It Wrong Again (Even with AHPA’s Help)

Courtesy of AHPA

When Consumer Reports (CR) first identified its “Dirty Dozen” dietary supplement ingredients in 2004, the media became very excited and reported broadly on this “news” and its catchy moniker. But there were a lot of problems with the list, and AHPA’s Steven Dentali, Ph.D. submitted a letter to the editor to provide some clarity:

• FDA had already forbidden the sale of herbs that contain aristolochic acid in the U.S. This was included on that 2004 list, as the only “definitely hazardous” material.
• It was wrong to say that skullcap (Scutellaria lateriflora) damages the liver, when it had been well established that case reports suggesting such effects should be attributed to adulteration with germander (Teucrium chamaedrys), which was not meaningfully present in the marketplace. Both skullcap and germander were on the 2004 list.
• The issue with pennyroyal (Hedeoma pulegioides) is related to internal use of the essential oil, not the herb itself. And while it was the oil that CR included in its “dozen,” only products made from the herb were identified.
• Federal regulators had acted as early as 2001 to remove comfrey (Symphytum officinale) from the market when offered for sale for internal use. 

Although the editor never acknowledged receipt of Dr. Dentali’s letter, it appears as if someone may have read it. The current issue of the magazine has revised and reprised the list. It still includes comfrey, but the other four (including germander) have now been removed, as have two non-herbal ingredients.

But apparently the tagline was too good to give up, so this year’s “Dirty Dozen,” just reissued in its September edition, has been repopulated with six other ingredients that again betray a lack of expertise. The four new herbs on the list are aconite, country mallow (Sida cordifolia), greater celandine (Chelidonium majus) and coltsfoot (Tussilago farfara).

As Matt Lauer said on the Today Show while interviewing Nancy Metcalf, CR’s Senior Program Editor on August 3rd: “I haven’t heard of most of these things.”

But even though these herbs might not be on the tip of everyone’s tongue or be key marketplace ingredients (Mark Brush at Nutrition Business Journal issued “A Response to Consumer Reports’ Scary Supplements” yesterday and provided figures that estimate the cumulative sales of these 12 ingredients as ~0.2 percent of the annual supplement market), Dr. Dentali offers the following thoughts:

• Aconite: In the U.S. aconite is primarily available as a homeopathic medicine, which has not been associated with any of the potentially toxic constituents in the plant itself. AHPA recommends that aconite root be excluded as an ingredient from dietary supplements available for retail sale.  
• Coltsfoot: AHPA has recommended since 1996 against the oral use of any herb that contains toxic pyrrolizidine alkaloids – including coltsfoot and also comfrey, which was retained by CR from its 2004 list. The Food and Drug Administration declared in 2001 that it considers any product for oral use that contains toxic pyrrolizidine alkaloids to be adulterated, and the Federal Trade Commission has also acted against the sale of such products. 
• Sida cordifolia: CR has identified a concern about “country mallow” based on “possible dangers linked with its ephedrine alkaloids.” If there is any ephedrine in Sida cordifolia, however (recent research suggests that there is not), it is present only at a very low level, less that 0.1 percent. And if this herb was, in fact, providing ephedrine it would not be legal to use in a dietary supplement.
• Several of the other herbs that were identified in both 2004 and CR’s current list are labeled to inform consumers of safety issues material to their use. For example, AHPA maintains a labeling policy for kava (Piper methysticum) that provides information that is consistent with FDA’s 2002 Consumer Advisory on this herb. And chaparral (Larrea tridentata), lobelia (Lobelia inflata), and yohimbe (Pausinystalia johimbe) are all classified by AHPA’s Botanical Safety Handbook in categories that identify specific cautions.

Consumers Union, the publisher of Consumer Reports, describes itself as an organization that was founded in part because consumers “lacked a reliable source of information they could depend on to help them distinguish hype from fact.” Unfortunately, the article that accompanies their new list (Anon. September 2010. Dangerous supplements. What you don’t know about these 12 supplements could hurt you. Consumer Reports) strays into sensationalism.

Much of this article is focused on individuals who suffered significant adverse events when taking products labeled as dietary supplements. These include one unfortunate man who took a product found to be laced with a synthetic steroid, and another who suffered from a product found to contain 200 times as much selenium as was stated on its label. But the first of these products was an illegal drug, and not a dietary supplement, and the second failed to comply with good manufacturing practice, and so was adulterated.

“Consumer Reports is attempting to draw broad conclusions about the regulation of dietary supplements based on anecdotes related to products that do not represent the mainstream,” noted Michael McGuffin, AHPA President. “This tone is unfortunate and misses an opportunity to express support for the efforts of responsible industry players to improve enforcement of the good laws already in place.”

One flu over the cuckoo’s nest? Phony Swine Flu products are dangerous

By James J. Gormley

“These are the times that try men’s souls.”
---“The Crisis” by Thomas Paine, December 23, 1776

As of May 17, 2009, 39 countries had officially reported 8,480 cases of “swine flu” (influenza A (H1N1) infection. Most confirmed cases were identified in Mexico (2,895 cases, 66 deaths) and the U.S. (4,714 cases, 4 deaths). The following states were hardest hit: Illinois (638 cases), Wisconsin (613), Texas (506), California (504), Arizona (435), Washington (246) and New York (242).

Although times of crisis, such as national health emergencies and global pandemics, bring out the best in most Americans, there have unfortunately always been some marketeers and hucksters who take advantage of the panic resulting from these tragic, and trying, times.

The current swine flu epidemic is no exception. On April 27th, 2009, within days of the first confirmed flu cases in the U.S., I received a press release announcing a nano-silver swine flu kit that was already being packed for shipment in “pre-paid overnight FEDEX boxes.”

I also received a “Swine Flu Alert” about a liquid silver supplement that allegedly “destroys MRSA, SARS, malaria, anthrax […] hepatitis C, HIV […] and bird flu.”

A day later, I stumbled upon an article posted on a Bulgarian news agency site with the following lead: “Bulgaria expects a huge increase in orders for two anti-flu dietary supplements in light of the current swine flu epidemic.” One of these products had already been the subject of a new dietary ingredient (NDI) rejection by the U.S. Food and Drug Administration (FDA) in early 2000.

On April 28th, I alerted Gary Coody to these scams; Gary is the national health fraud coordinator in the FDA’s Office of Enforcement. I also reached out to officials from the U.S. Federal Trade Commission (FTC).

Meanwhile, others in the natural products industry, including leading organizations, were quick to respond to these opportunistic peddlers. Industry responders included the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) --- which issued a joint press release, on May 1st, that included the following call-to-action:

“Marketers and retailers of dietary supplements are urged to refuse to stock or sell any supplements that are presented as treating or curing swine flu.”

According to Michael Chappell, FDA’s acting associate commissioner for regulatory affairs, “In conjunction with the [FTC], the FDA has developed an aggressive strategy to identify, investigate and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.”

“Scam artists follow the headlines, trying to make a fast buck with products that play off the news --- and prey on concerned people,” said Eileen Harrington, acting director of the FTC’s Bureau of Consumer Protection. “We’re online and telling e-marketers their sites must comply with the law.”

The FTC has developed a new consumer alert, “Rx for Products That Claim to Prevent H1N1? A Healthy Dose of Skepticism” (http://ftc.gov/bcp/edu/pubs/consumer/alerts/alt083.shtm). It warns the public to be skeptical of claims that products like pills, air filtration devices and cleaning agents can supposedly kill or eliminate the virus.

This is, of course, not the first time that Internet peddlers have tried to take advantage of consumers during scares and epidemics.

By March 2002, the FTC had sent warning letters to 121 web sites selling products to “protect against, detect or treat illnesses caused by biological or chemical agents, including anthrax.” The products, most of them bogus or ineffective, included herbal remedies, air filters, gas masks and “do-it-yourself kits to test mail for anthrax.”

In 2005, the FDA issued warning letters to nine companies marketing phony avian flu products. The use of these fake products “increases the risk of catching and spreading the flu rather than lessening it because people assume they are protected and safe and they aren’t,” said the acting FDA commissioner on December 13th, 2005.

Gormley Take-Away: We should steer clear of any dietary supplements which claim to prevent, treat or cure swine flu --- and, for that matter, any virus or outbreak of any kind. Legitimate supplements, including herbals, are great for promoting health and helping us cope with the common, everyday nasties that come our way. But let’s leave the gas masks in the fallout shelters, okay?