The supplement market has been hit with some pretty negative press over the last week, thanks to the meta-analysis questioning the safety of calcium supplements and Consumer Reports’ cover story on what it calls “the 12 most dangerous supplements.” Yet, it’s a third piece of news that broke regarding a product called the Miracle Mineral Solution that has me concerned. After all, the quality and validity of the calcium meta-analysis is debatable, and the Consumer Reports piece also advises consumers to consider taking what the magazine says are 11 safe and beneficial supplements—but I believe the MMS issue is a symptom of a more serious problem that threatens the legitimacy of the entire supplement industry.

On July 30, the U.S. Food and Drug Administration (FDA) issued a warning to consumers about Miracle Mineral Solution (also called Miracle Mineral Supplement and MMS). What’s the cause of FDA’s concern? Well, apparently when this product is consumed according to the directions on its label, this liquid mineral supplement turns into a “potent bleach used for stripping textiles and industrial water treatment,” the agency reported in a warning letter to consumers. As if that weren’t alarming enough, MMS marketers and distributors claim the product can treat an unbelievable range of diseases, including HIV, hepatitis, the H1N1 flu virus, acne and cancer.

Available for purchase via a wide range of Internet sites (including Amazon.com and eBay) and sold through several different companies, MMS contains 28% sodium chlorite. The product’s labeling advises consumers to mix MMS with an acidic drink such as orange juice, which turns the solution into an industrial-strength bleach. The FDA said it received several reports from consumers using MMS who experienced serious adverse reactions, including “severe nausea, vomiting and life-threatening low-blood pressure from dehydration.”

Upon reading the FDA’s warning, my immediate reaction was, “Why the heck is this product still on the market?” The agency did say it is continuing to investigate MMS and “may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product,” but I’m wondering what will be required to push the agency to take more forceful action.

I posed that question to supplement and food attorney Marc Ullman, who turned out to be equally perplexed by this situation. “I have no idea why this product is still on the market,” Ullman told me via e-mail. “To my knowledge, the long history of outrageous claims associated with [MMS] is well documented.” According to Ullman, the last product posing such potential health risks was GHB (gamma-hydroxybutyric acid), a precursor to GBL (gamma buterol lactone), a.k.a. “date rape drug.”

“FDA did bring criminal charges against some distributors in that instance,” Ullman said. “If the allegations here are correct, I think that similar action would be warranted. In fact, I believe that criminal charges could easily be justified based on the kind of claims associated with MMS alone.”

What do you think should happen with MMS? Should responsible industry take steps to get involved and protect itself from products such as MMS?

Related NBJ links:

2010 Nutrition Industry Overview Web Seminar

FDA Files Motion to Shut Down Three Sports Supplement Manufacturers

Although my opinion could be considered biased, the NBJ Summit team—led by Patrick Rea and Tom Aarts—outdid itself again with this year’s annual gathering of nutrition industry leaders. Held July 21-23 at the St. Regis Resort in Dana Point, California, the sold-out 2010 NBJ Summit brought together more than 300 CEOs, presidents and other executives for what proved to be an inspiring, instructive and thought-provoking three days of education and networking.

Below are several of the key messages that emerged from this year’s NBJ Summit:

• Innovate your way out of a downturn: The recession took a big bite out of the nutrition industry’s product development activity in 2009, as many companies focused on survival rather than creating their next breakthrough product. But, as Sterling Rice Group Managing Partner John Grubb demonstrated in his keynote titled “The Imperative to Innovate: Disrupting the Competitive Context,” downturns are the exact wrong time to put the brakes on new product innovation. As Grubb noted, with higher risk comes greater reward, making game-changing innovations the key to thriving during tough times and claiming more than your fair share of a market opportunity. Also, product line extensions tend to make up most of a company’s revenues, but new products drive the greatest profit growth.

• Fail fast: True innovation isn’t possible without the risk of failure—and, as Grubb told NBJ Summit attendees, most of what you do will be wrong at first, so prepare to fail quickly and use the lessons from your missteps to move your innovations forward. Because failure is a natural part of innovation, the innovators in a company must be given the time to learn from their mistakes, Grubb added. Of course, creating a forward-thinking ecosystem of innovation can be more easily accomplished at private companies, which are typically not held hostage to quarterly results the way public companies can be.

• Prepare to be scrutinized: Whether it’s coming from the U.S Food and Drug Administration (FDA), the Federal Trade Commission (FTC) or the “bounty hunter” law firms looking to get rich off of class-action consumer lawsuits, U.S. nutrition companies must be prepared to have their products, science and claims put under the microscope. Serious future scrutiny could come from FDA’s impending new dietary ingredient (NDI) guidance, which could publish later this year. If the guidance becomes stricter, an estimated 40%-60% of the current dietary supplement market could be adversely affected.

• Make the world your oyster: As Christine Holgate, CEO of Australia’s largest dietary supplement company, Blackmores, told a packed Summit audience: Even those companies with successful, fast-growing businesses in their home markets should consider global expansion. Under Holgate’s leadership, Blackmores is now in seven markets and is considering launching into others. According to Nutrition Business Journal estimates, total global nutrition industry sales grew 6.6% to $288 billion in 2009. This growth was somewhat higher than the 4.4% growth the $108 billion U.S. nutrition industry experienced last year.

• Choose your global partners carefully: As NOW Health Group President and CEO Al Powers told Summit participants, moving into a new market without carefully vetting your in-country partners or fully understanding the business culture can be expensive mistakes. Powers candidly told the audience that he learned this lesson the first time NOW entered the Chinese market a decade ago and the company’s Chinese partner stole NOW’s product and then marketed other counterfeit supplements under the NOW brand. The experience didn’t scare NOW away from the promising Chinese market, however: Under Power’s guidance, NOW is once again building its business in China—this time with much more success.

• Don’t be afraid of big pharma: Former GlaxoSmithKline (GSK) executive Stephen Stefano spent his NBJ Summit keynote address attempting to convince the audience that pharmaceutical companies—like GSK—can be good partners for the nutraceutical industry. As Stefano explained, blockbuster drugs are becoming fewer and far between and the margins for pharmaceuticals continue to shrink. This is making it more important than ever for drug companies to diversify their product offerings. “The climate is ripe for pharmaceutical companies to get involved in nutraceuticals in a productive way,” Stefano said. He used GSK’s prescription fish oil product, Lovaza, as an example of a “nice fit between pharma and supplements.” Global sales of Lovaza have now topped $1 billion, leading many Summit participants to wonder: What will be the next blockbuster supplement-based drug?

• Never forget Rule No. 6: One of the most inspirational moments during the 2010 NBJ Summit came from Benjamin Zander during his keynote address. In what was (correctly) billed as a life-transforming talk, the Boston Philharmonic Orchestra conductor coached attendees to live their lives and lead their organizations from the viewpoint of possibility rather than from fear, anger or complacency. My favorite part came when Zander presented what he calls Rule No. 6: “Don’t take yourself so damned seriously.” Duly noted!

• Live like Ohno—no regrets: The 2010 NBJ Summit closed on another inspirational high note with the keynote address from eight-time Olympic medalist Apolo Ohno. Ohno, who has launched his own dietary supplement company called 8 Zone, opened himself up to questions about everything, including why he created 8 Zone, what supplements he takes, the music that keeps him going during training and why he respects the South Koreans (who have been some of his greatest competitors on the ice). In explaining how he was able to dedicate four years of rigorous training to prepare for a few minutes of Olympic speed skating competition, Ohno said he learned to remain focused on the journey and live each day with no regrets.

Registration for the 2011 NBJ Summit will open later this year. Sign up early, as this year’s event sold out.

Related NBJ links:

Going Global: Taking Your Business Overseas & Getting it Right the First Time

Leadership Secrets from Top CEOs - Growing Your Business (and your career) in 2011 and Beyond

Both here and in Europe, dietary supplements and functional foods and beverages are feeling the health-claims heat. While the European Food Safety Authority continues its stringent evaluation of food and supplement health claims (rejecting the vast majority of claims it reviews), the Institute of Medicine (IOM) in the United States is calling for the U.S. Food and Drug Administration (FDA) to begin applying the same health-claims assessment methods for foods and supplements as it does for pharmaceutical drugs. In an IOM report released May 12, an IOM committee concluded “that there is neither rationale nor scientific grounds for basing regulatory decisions on different levels of scientific evidence for different substances—science is science.” The report also noted that Congress “may need to strengthen FDA authority to accomplish this goal.”

Not surprisingly, the report triggered an onslaught of news stories, many of them highly critical of dietary supplements and functional foods and beverages. In its June 7, 2010, issue, Forbes Magazine takes on the $37 billion U.S. functional food and beverage industry in a story titled “Snake Oil in Your Snacks.” The piece argues that food and ingredient companies are getting rich by trying to pass their products off as pharmaceutical-like drugs without backing the health claims made for those products with pharmaceutical-grade research. To support this argument, the article analyzes the studies linked to a handful of functional products, including Lifeway’s ProBugs kefir beverage for kids, POM Wonderful’s pomegranate juice and Danone’s DanActive yogurt.

“[Most of the claims] are completely unsubstantiated,” Steven Nissen, head of cardiology at the Cleveland Clinic, told Forbes. “Medical attention does not come from a Cheerios box.”

My biggest issue with both the IOM report and articles like the Forbes “snake oil” piece is that dietary supplements and functional foods and beverages are NOT drugs and consumers typically use these products to support their health over the long haul. A person isn’t likely to replace his cholesterol-lowering medications with Cheerios but might choose this cereal over another for its heart-healthy soluble fiber content. Similarly, I don’t give my sons ProBugs thinking that the fun kefir drinks will strengthen their immune systems so much that we no longer need to worry about eating fresh fruits and vegetables or regularly washing our hands. I do, however, appreciate that ProBugs are organic, contain no artificial colors or flavors, and are rich in calcium, vitamin D and, yes, probiotics.

As Stephen Daniells, the science editor for NutraIngredients, eloquently argued in an editorial published last week, “The regulation of food and drugs may come under the auspice of one agency in the U.S.—FDA—but foods and drugs are different. Just because Hippocrates said food should be our medicine, doesn’t mean we should regulate them as the same thing.”

That said, the dietary supplement and functional food and beverage industries have been home to companies that borrow science, use less-than-efficacious amounts of functional ingredients and/or make outrageous, unsubstantiated claims for their products. These are the companies drawing the ire of practitioners, lawmakers, regulators and the media and bringing about the very real possibility of tougher regulations for both the supplement and functional product industries.

Furthermore, even though supplements and functional foods are not drugs, companies would be wise to take a conservative approach to their product claims and invest in quality research to support the claims they choose to make for their products. This is already the reality in Europe, but the tougher stance on claims substantiation is obviously crossing over the pond to the United States. In the end, raising the level of scientific investment in both the supplement and functional industries will benefit responsible companies and consumers alike.

Nutrition Business Journal’s 2010 Healthy Foods Report, which publishes later this month, provides an in-depth look at the U.S. functional food market. NBJ subscribers receive a 10% discount when they use the code nbjsub10 to purchase this report.

Related NBJ links:

February 2010: Functional Foods and Beverages

European Union’s Health Claims Legislation Sets Nutrition Industry on Edge

2009 Supplement Business Report

UPDATE: According to a press release issued April 27 by The Cornucopia Institute, the USDA’s National Organic Program released a memo today (after the original publication of this blog post) saying that it would ban synthetic “accessory nutrients” from use in organic infant formula or baby food. An April 28 Washington Post article reported that the USDA will provide guidelines for how companies must phase out the additives in their organic products. The process could take more than a year.

Kathleen Merrigan, deputy secretary of the U.S. Department of Agriculture (USDA), is living up to promises that her agency, under the Obama Administration, will get tough on abuses involving the USDA organic seal. According to an April 26 Wall Street Journal article, Merrigan’s latest crackdown involves moving to ban synthetic versions of the fatty acids DHA and ARA from organic baby formula. Martek Biosciences Corp. is the largest supplier of synthetic fatty acids, and its DHA and ARA—sold under the life’sDHA and life’sARA brands—are found in more than 95% of all U.S. infant formulas, including organic formula sold under Abbott Lab’s Similac and The Hain Celestial Group’s Earth’s Best brands.

The USDA’s actions are in response to a legal complaint filed by the organic watchdog group The Cornucopia Institute to enforce federal organic standards prohibiting the use of certain unapproved synthetic substances in organic infant formula and other organic products. “Consumers rightfully expect organic foods to be purer and safer than conventional foods—in part because federal regulations require that they be free from potentially harmful synthetic additives,” said Charlotte Vallaeys, farm and food policy analyst with The Cornucopia Institute. “But in the case of the synthetic, chemically extracted additives DHA and ARA, the system of federal regulations ensuring organic integrity was undermined by corporate lobbying and backroom deals during the Bush Administration.”

Although the USDA is not challenging the safety of synthetic fatty acids, the agency has decided that the organic regulators in 2006 should have sought public comment when they decided to include synthetic versions of DHA and ARA on a list of nonorganic ingredients that can be used in products carrying the USDA organic seal. “We don’t want an industry that acted in good faith to be harmed,” Merrigan told the Wall Street Journal. “On the other hand, we have a rule to uphold.”

Merrigan said the USDA will issue a draft guidance on the issue later this year that would provide food manufacturers a grace period to reformulate their organic food products. Once the draft guidance is issued, public comment will be collected for 60 days and then the USDA will issue a final ruling, the Wall Street Journal reports.

Martek’s life’sDHA is also found in other organic products, including WhiteWave’s Horizon Organic Milk Plus DHA. The company’s synthetic fatty acids, which have been on the market since 2002, are extracted from microorganisms using hexane, a non-organic chemical that is frequently used in the production of cooking oils but that has been banned from use in organic food products.

In its complaint to the USDA, the Cornucopia Institute cited reports of babies being sickened by the synthetic fatty acids added to infant formula. Martek spokeswoman Cassie France-Kelly told Nutraingredients-usa.com earlier this month that “there has been no statistical rise in the number of adverse events” since Martek’s ingredients were introduced into infant formulas in 2002. “The fact is babies get sick, some react to infant formula yes, but that could be milk proteins or other ingredients,” France-Kelly said. “To link these ailments with the presence of omega-3s and omega-6s is spurious at best.”

Numerous studies have demonstrated the health benefits of omega-3s and omega-6s for infants, although The Cornucopia Institute said it rejects such findings. “Two recently published comprehensive scientific review studies on the topic both substantiate Cornucopia’s findings that challenge these claims,” the watchdog group wrote in a April 21 press release. “These two meta-analysis studies collectively consider the results of 18 clinical trials, and conclude there are no proven benefits to DHA/ARA supplementation in infant formula.”

In 2009, U.S. consumer sales of organic formula totaled $64 million, according to Nutrition Business Journal estimates. France-Kelly told the Wall Street Journal that a ban of its synthetic ARA and DHA from organic products “wouldn’t have a material impact” on Martek’s financial results because the company primarily sells its ingredients for use in conventional products.

NBJ is interested in your thoughts on this issue. Should synthetic fatty acids be banned from organic baby formula? Does such a move strengthen the integrity of the USDA organic seal, or does it hurt consumers by forcing them to choose between buying organic formula and formula that has been supplemented with the fatty acids that many parents believe are important to their babies’ health?

Related NBJ links:

2010 Organic Foods, Beverages and Personal Care

Martek Strengthens its Hold on Baby Formula Supply Market

2009 Raw Material & Ingredient Supply Report

Eight dietary supplement manufacturers and marketers were named in a California lawsuit filed on March 2 that alleges some fish oil supplements have been sold containing illegally undisclosed and unnecessarily high levels of contamination with polychlorinated biphenyl (PCB) compounds. The eight companies named in the lawsuit are: CVS Pharmacy Inc., General Nutrition Corp. (GNC), Now Health Group Inc., Omega Protein Inc., Pharmavite LLC, Rite Aid Corp., Solgar Inc., and TwinLab Corp. The lawsuit alleges that the companies sold fish oil, shark oil, fish liver oil and shark liver oil supplements that have PCB contamination above the so-called “safe harbor” limits set for human PCB consumption under California’s Proposition 65. That law requires companies to warn consumers about contaminant exposures. Proposition 65, passed as a ballot initiative in 1986, was passed to force consumer products to eliminate toxic chemical ingredients or reduce them below published safe harbor limits in the past.

U.S. consumers spent $739 million on fish and animal oil supplements in 2008, making it the eighth most popular dietary supplement on Nutrition Business Journal’s list of the top 100 selling supplements in the United States. Many within the industry are wondering what the potential implications this lawsuit could have on the fish oil supplement market. NBJ reached out to two industry trade associations, as well as to legal experts with the Goodwin Procter law firm to determine what effect this might have on the industry; their responses are included below along with a statement from one of the defendants, TwinLab Corp.

• Forrest Hainline, attorney at the San Francisco office of Goodwin Procter: This threatened lawsuit highlights an essential problem in applying Proposition 65 to foods or supplements. The evidence is uncontroverted that omega-3 fatty acids are not only beneficial but essential for health. The evidence is overwhelming that Americans in general do not eat enough fish to obtain the appropriate amounts of omega-3 fatty acids. This might be due in part to the campaign to frighten people away from eating fish for fear of methyl mercury.

As the California Supreme Court recognized in Dowhal v. SmithKline Beecham Consumer Healthcare, 32 Cal.4th 910 (2004), “even if scientific evidence supports the existence of a risk, a warning is not necessarily appropriate: The problems of over warning are exacerbated if warnings must be given even as to very remote risks.” This is particularly true where the benefit of the product folks would be warned against outweigh the potential harm. This was true in the Tuna Case, which I tried and won. The benefits of eating fish (because of omega-3 fatty acids, among other benefits) far outweighed the remote and even theoretical risk of exposure to the minute amounts of methyl mercury.

The Food and Drug Administration (FDA), not a bounty hunter law firm under Proposition 65, should determine whether warnings on foods or supplements are appropriate, and what form they should take.

Note: Hainline also obtained a judgment for restaurants that Proposition 65 warnings concerning grilled chicken were preempted by federal law.

Joanne Gray, attorney at the New York City office of Goodwin Procter: I have provided legal advice to a number of dietary supplement companies over the years and have been continually disappointed at the number of frivolous lawsuits that have been filed against the industry, including Proposition 65 claims, consumer class actions claims and products liability lawsuits. It is important to mount a strong defense to these actions right from the start.

It is unfortunate that dietary supplement companies and retailers have faced Proposition 65 lawsuits, even when minute amount of substances hold no real risk of harm to the consumer. These lawsuits are a real threat to the survival of the smaller companies in the industry, and they also increase costs to consumers.

• Council for Responsible Nutrition (CRN): CRN believes the suit was filed in California in order to take advantage of a state law, Prop 65, which has conservative standards that are not law in the rest of the nation. Further, the information disclosed during the press conference danced around the details, offering a lack of specificity to the general public about the levels of polychlorinated biphenyl (PCB) compounds found in the fish oil products that were tested. Though the lawyers suggest that the levels of PCBs found in these products far exceed what is acceptable by Prop 65 standards, the actual levels of PCBs found in the majority of these products do not appear to exceed the Prop 65 limit (90 ng/day). Furthermore, they fail to mention that the Food and Drug Administration’s (FDA) tolerance level for PCBs in fish (2,000 parts per billion) far exceeds the levels of PCBs found in fish oil…

The bottom line is that consumers, whether they live in California or elsewhere, should continue to feel confident in the safety and efficacy of their fish oil supplements. This lawsuit does nothing to change the strong science supporting the many health benefits of fish oil, which range from cardiovascular health to cognitive development of infants and young children, and the very low thresholds of PCBs which apparently trigger a labeling requirement in California cannot be extrapolated to demonstrate any actual risks at those levels. The health benefits for fish oil far outweigh any suggested, and unsupported, risks.” Read the entire statement here.

• Global Organization for EPA and DHA Omega-3 (GOED): In response to a lawsuit being filed against eight dietary supplement brands and retailers, the Global Organization for EPA and DHA Omega-3s (GOED) is reassuring the industry and consumers that fish oils manufactured by its members, and the market in general, meet the highest quality standards available. “We have complete confidence in the safety of the fish oil supplement market, which has been validated through multiple third-party reviews by industry watchdogs on thousands of products,” said Adam Ismail, Executive Director of GOED. “In fact, this industry is among the highest quality and most transparent of all consumer products,” he added.

There are multiple resources in the public domain where consumers can get more information on the quality of their products, including the International Fish Oil Standards program (www.ifosprogram.com). Furthermore, a recent report by Frost & Sullivan found that 93% of the refined fish oils on the market in the United States are produced from anchovy and sardine oils. However, the plaintiffs unfortunately only tested one of these types of oils, which actually had PCB content well within the Safe Harbor provisions of Proposition 65. “While the plaintiffs raise an important issue,” said Ismail, “it is unfortunate that they are implying that most fish oils are unsafe and that the industry is hiding information on such vital nutrients.” Read the entire statement here.

• Greg Grochoski, Twinlab’s chief science officer: “Twinlab’s fish oil products are all molecularly distilled and quality tested for purity. These processes are especially effective for reducing impurities such as PCBs found in oceans, lakes, rivers and streams and common to fish and fish-­‐based products.” Twinlab’s statement went on to say that the company cannot comment on the validity or accuracy of the tests referenced by the plantiffs, though its products were reported as having among the lowest level of impurities.

Related NBJ Links:

Tuna’s Prop 65 Win Could Help Supplement Firms in Their Own Lawsuits

Elite Athletes Eschew Dietary Supplements Over Fears of Contamination

Vitamin D and Omega-3 Fish Oil to be the Focus of New $20 Million Study