Baseball gets dietary supplement regulation back in the game

In part due to Major League Baseball, members of Congress are re-considering how the $25 billion U.S. dietary supplement industry is regulated.

Last week, the Senate Judiciary Committee Subcommittee on Crime and Drugs heard testimony on whether current laws and regulations are sufficient to protect consumers from ingredients that may appear in supplements, but not on their labels. The interest of Chairman Arlen Specter (Dem-PA) is due in part to the court case of Philadelphia Phillies pitcher J.C. Romero, who was suspended for 50 games this year after testing positive for a banned substance. Earlier this year, Romero sued the manufacturer of an over-the-counter supplement, blaming the company for his suspension on the claim that it misrepresented ingredients in its products.

Under current law, no government agency evaluates the contents of dietary supplements to confirm the presence of ingredients listed on the label (or to discover those unlisted). Furthermore, dietary supplement manufacturers do not have to prove the safety or efficacy of the product to gain Food and Drug Administration approval prior to marketing. Rather, companies must submit some evidence that the product has a history of use or benefit 75 days before selling it. The safety burden falls on the FDA: if it believes a supplement to be unsafe it must demonstrate the public health risk in court. NYU nutrition professor Marion Nestle covers the history of this issue in detail in her book, Food Politics, as well as on her blog.

In his testimony, Michael Levy, the Director of the Division of New Drugs and Labeling Compliance at the FDA, describes this as, “a painstaking investigative and analytical process to show that [the products] are violative.” He states that the process can take many months, during which the product in question remains on the market, limiting the FDA’s ability to effectively protect consumers.

The largest trade association for the natural products industry, the Natural Products Association, also supported stricter enforcement of supplement contents. However, rather than questioning the effectiveness of current procedures, Interim Executive Director Daniel Fabricant called for increased money and manpower to enforce current law. He argues that sufficient resources would enable the FDA to pursue a larger number of investigations and court cases.

Batting averages are not the only outcomes at stake in this regulatory debate. Use of steroid-like compounds has been associated with kidney failure, liver injury, and stroke.

It will be interesting to see how the debate unfolds. The Major League Baseball Players Association is reported to be lobbying Congress to require that a federally certified lab analyze all supplements to identify the ingredients that should be listed on the label. Professional athletes may hit a regulatory home run that consumer safety advocates have sought for more than a decade.

Written by Natalie Valpiani, a graduate student at the Friedman School of Nutrition Science and Policy at Tufts. Cross-posted from a University of North Carolina food seminar blog, Eats 101.

The IOM considers what to do about salt

If a new food additive had the same effects as salt, promoting high blood pressure in a large fraction of the population, it is doubtful the additive would be approved by the Food and Drug Administration (FDA). Yet, the official status of salt in federal regulations is "GRAS" or "Generally Recognized as Safe" -- a broad category that includes food ingredients such as vinegar that were grandfathered at the time that modern regulation of food additives began.

Nobody seems to know the right way to regulate salt. Strict regulation as a food additive raises concerns about Orwellian government overreach. Doing nothing leads to thousands of deaths from stroke and heart disease each year. Consumer education is a weak response, because most salt in the diet comes from processed and restaurant food, not salt from shakers. The American Medical Association recommends warning labels.

An Institute of Medicine (IOM) committee of experts is preparing a new report on Strategies to Reduce Sodium Intake. The three presentations from federal agencies at the committee's first meeting were very different in tone, ranging from ambitious to nearly complacent. The next open meeting of the IOM committee, on March 30 in Washington, DC, will be an important venue for policy debate about salt and sodium.

High fructose corn syrup contaminated with mercury and other food safety news

I can't wait to see the new ad-campaign to try to wiggle out of this one. The Institute for Agriculture and Trade Policy has issued a report, Not So Sweet: Missing Mercury and High Fructose Corn Syrup, revealing that mercury was found in nearly 50 percent of tested samples of commercial high fructose corn syrup (HFCS). The research article was published January 26th in the scientific journal, Environmental Health by Renee Dufault et al. From the IATP report:

What she found was that possible mercury contamination of these food chemicals was not common knowledge within the food industry despite the availability of product specification sheets for mercury-grade caustic soda that clearly indicate the presence of mercury (as well as lead, arsenic and other metals). Upon further investigation, she found mercury contamination in some commercial HFCS, which can be made from mercury-grade caustic soda.

Through this public scientist’s initiative, the FDA learned that commercial HFCS was contaminated with mercury. The agency has apparently done nothing to inform consumers of this fact, however, or to help change industry practice.Consumers likely aren’t the only ones in the dark. While HFCS manufacturers certainly should have been wary of buying “mercury- grade” caustic soda in the first place, the food companies that buy finished HFCS and incorporate it into their processed food products may be equally unaware of how their HFCS is made, i.e., whether or not it is made from chemicals produced by a chlorine plant still using mercury cells.

The HFCS isn’t labeled “Made with mercury,” just like contaminated pet foods, chocolates and other products have not been labeled “Made with melamine.” Under current regulations, that information is not made available to either consumers or to companies further down the food supply chain.

When we learned of this gap in information, we set out to do the FDA’s work for it. We went to supermarkets and identified brand-name products—mainly soft drinks, snack foods and other items mostly marketed to children—where HFCS was the first or second ingredient on the label.

We sent several dozen products to a commercial laboratory, using the latest in mercury detection technology. And guess what? We found mercury. In fact, we detected mercury in nearly one in three of the 55 HFCS-containing food products we tested. They include some of the most recognizable brands on supermarket shelves: Quaker, Hunt’s, Manwich, Hershey’s, Smucker’s, Kraft, Nutri-Grain and Yoplait.

No mercury was detected in the majority of beverages tested. That may be important since sweetened beverages are one of the biggest sources of HFCS in our diets. On the other hand, mercury was found at levels several times higher than the lowest detectable limits in some snack bars, barbecue sauce, sloppy joe mix, yogurt and chocolate syrup. Although closer to the detection limit, elevated mercury levels were also found in some soda pop, strawberry jelly, catsup and chocolate milk. The top mercury detections are summarized in Table 3, on page 14 of the report.

Environmental mercury from chlorine plants, coal-fired power plants, dental offices and other sources have helped contaminate albacore tuna, swordfish and many of our favorite fish with mercury. Eating these fish has long been thought to be the most important mercury exposure for most people.

However, HFCS now appears to be a significant additional source of mercury, one never before considered. When regulators set safe fish consumption recommendations based on an understanding of existing mercury exposure, for example, they never built mercury contaminated HFCS into their calculations. HFCS as a mercury source is a completely avoidable problem. HFCS manufacturers don’t need to buy mercury-grade caustic soda. And the chlorine industry doesn’t need to use mercury cell technology. In fact, most chlorine plants in the U.S. don’t use it anymore, as it is antiquated and inefficient.

While we wait for the FDA to do its job and eliminate this unnecessary and completely preventable mercury contamination, we have a few suggestions for what you as consumers and voters can do.

Currently, food manufacturers don’t list on their products the source of HFCS and whether or not it is made from mercury-grade caustic soda. So call them. Make use of the toll-free numbers or Web sites on many packages, and let companies know you’re not comfortable eating their product until you know exactly what is in it. As voters, call your elected officials and ask them for hearings to find out why the FDA is not protecting us from mercury in HFCS.

Also, ask these officials to reintroduce legislation originally proposed by then-Senator Barack Obama a few years ago that will force the remaining chlorine plants to transition to cleaner technologies. Because even if they stop providing the caustic soda used for HFCS, their mercury pollution is still contaminating our food system as it falls on farm fields and waterways.

Tom Philpot at the Grist also covers this topic in Some heavy metal with that sweet roll? Seems to me the house of cards is falling with food safety. In the FDA's spotlight is salmonella in peanut butter from mildew in peanut butter plants, melamine in dry milk from China, and the myriad of meat contamination, with its sights probably on the newest report of Methicillin-Resistant Staphylococcus aureus (MRSA) being found in swine and swine farmers in the Netherlands and Canada. The more of these reports that continue to surface, the more people will be looking towards alternative food systems.

Stevia sweetener gets FDA salute

Two agency response letters posted on the FDA site, confirmed to Cargill, Incorporated and Whole Earth Sweetener Company LLC that Rebaudioside A (a sweetener derived from the Stevia leaf) is, in fact, Generally Recognized as Safe (GRAS), thus giving the companies the green light for use in the US food supply. According to FoodProcessing: A Home Page for the Food and Beverage Industry, "Rebaudioside A's natural sweetening capacity makes it ideal for the food and beverage industries."

According to Food Navigator USA, “within hours Coca-Cola and PepsiCo announced that their first drinks sweetened with Reb A will be hitting US shop shelves shortly. Coca-Cola partnered with Cargill to develop their rebiana brand called Truvia, and PepsiCo, along with Whole Earth Sweetener Company (a subsidiary of Merisant Company) and PureCircle, have their own product under the PureVia brand."

Many are still critical of the industry sponsored research and FDA's seemingly hastily 'midnight' decision, including Marion Nestle at What to Eat, Center for Science in the Public Interest (CSPI) and Asinus Asinum Fricat at La Vida Locavore, who have been covering the developments.

The FDA letters concluded that:

Based on the information provided by Cargill (Whole Earth), as well as other information available to FDA, the agency has no questions at this time regarding Cargill’s(Whole Earth) conclusion that rebaudioside A purified from S. rebaudiana (Bertoni) Bertoni is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of rebaudioside A purified from S. rebaudiana (Bertoni) Bertoni. As always, it is the continuing responsibility of Cargill(Whole Earth) to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

Should FDA give waivers to panel members who have conflicts of interest?

Two recent analyses offer opposing views about whether the Food and Drug Administration (FDA) should give waivers to outside experts, allowing them to participate on important government panels despite conflicts of interest.

The Food and Drug Administration (FDA) relies on expert scientists as advisers on a host of panels, which strongly influence the agency's oversight of important issues ranging from food safety to the approval of new drugs and medical equipment. The advisers may have conflicts of interest, such as having received research funding from a company whose products are being reviewed by the panel. In some cases, FDA grants waivers to the rules prohibiting conflicts of interest, on grounds that the conflict is minor or that the adviser offers unique expertise that outweighs the concern about conflict.

Last spring, the FDA proposed new rules that would limit such waivers. According to a summary from the Center for Science in the Public Interest (CSPI): "Those guidelines would ban anyone with greater than $50,000 a year in financial ties to industry from advisory committees and deny a vote to anyone with lesser conflicts."

However, more recently FDA has emphasized the value it places on waivers, arguing that it would be difficult to replace the expertise of many advisers who have conflicts of interest. FDA cited a report (.pdf) from the Eastern Research Group, which reviewed a number of panels and argued that FDA might not be able to make do without the experts who received waivers (the report's first author, Nyssa Ackerley, is a former student of the food policy program here at the Friedman School).

By contrast, according to CSPI's Integrity in Science newsletter, a coalition of public interest groups including CSPI analyzed the same data and reached the opposite conclusion:

For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest, according to CSPI's analysis of the ERG data. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not.

Do you think FDA should grant waivers to conflict of interest rules to recruit expert panelists who would otherwise be ineligible? Comments are open.

Sentences for former FDA commissioners -- a cross-country comparison

In the United States this Spring (Associated Press via news-medical.net):

U.S. Magistrate Judge Deborah Robinson on Tuesday sentenced former FDA commissioner Lester Crawford to three years of supervised probation and ordered him to pay fines of about $90,000 for false reporting and conflicts of interest related to ownership of stocks in companies regulated by the agency, the AP/Washington Times reports.

In China this week (Associated Press via the Guardian):

BEIJING (AP) - China on Tuesday executed the former head of its food and drug watchdog who had become a symbol of the country's wide-ranging problems on product safety.

Zheng Xiaoyu's execution was confirmed by State Food and Drug Administration spokeswoman Yan Jianyang at a news conference held to highlight efforts to improve China's track record on food and drug safety.

Wild world of nutrition supplements to get just a little oversight

The Food and Drug Administration (FDA) on June 25 announced new rules for the manufacture of dietary supplements, which will help ensure that they they have proper labels and contain what their labels say. The announcement is accompanied by instructions for public comments.

Despite the new rules, nutrition supplements are still wildly unregulated by comparison to drugs. Under a controversial 1994 law known as the Dietary Supplement Health and Education Act (DSHEA), Congress denied FDA the power to regulate existing dietary supplements as pharmaceuticals and prevented FDA from requiring manufacturers to prove that supplements are safe or effective (see the mildly stated FDA view of this limitation and a quote from the Consumers Union).

Leading nutrition researchers, such as Alice Lichtenstein and Robert Russell here at the Friedman School of Nutrition at Tufts University, have spoken out with increasing vigor in recent years about the importance of getting nutrients from real foods (see a scholarly statement of their views and a Tufts news article).

[Update: another colleague here points out the pace of the federal government's progress on this issue: the new rule took 13 years to prepare and it will be another 1-3 years for implementation.]