Peter Quinter of Becker & Poliakoff

Guest Post from The Customs and International Trade Law Blog

The U.S. Food and Drug Administration recently issued several warning letters to prominent food and drink companies regarding false claims displayed on their food and drink products, including those marketed to children.  Some food products brazenly claim to increase a person’s immune system, reduce the chance of getting a cold, or even cure cancer.  Are they really believable?

The Obama Administration has taken a more aggressive posture to attempt to reduce the obesity of Americans, especially children.  There is a direct connection between what we eat and our health.  Remember the saying ”You are what you eat”?   Dr. Margaret Hamburg, the new FDA Commissioner, announced in a March 3, 2010 letter to food companies:

I have made improving the scientific accuracy and usefulness of food labeling one of my priorities…It is clear to me as a working mother that the use of front of pack nutrition symbols and other claims can be helpful to busyy shoppers who are often pressed for time in making their food selections.

In a typical Warning Letter to one of the worlds’ largest food companies, Nestle, in a December 4, 2009, the FDA complained about Juicy Juice All Natural 100% Juice Grape products.  The FDA alleged that the product was misbranded because the lables were misleading in that the label was designed to imply that the producct is 100% grape juice when it truly was not.

The FDA regulations regarding food, including drinks, are complex.  True and accurate health claims are allowed on certain food products under specific circumstances, according to the FDA guidance.  Hopefully, the food industry will be more responsible, and if not, I encourage Commissioner Hamburg to pursue civil penalties against companies and the corporate officers of those companies who deceive the public. 

A discussion about health claims on food products and how to respond to FDA Warning Letters will take place on June 3, 2010 in Miami, at a seminar entitled “Importing Food Products in Compliance with FDA and U.S. Customs Rules“. 

In solidarity with FDA Commissioner Hamburg, I am a working Dad, and I don’t like to be lied to either!

Thanks Peter!  -Ed.

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Don Witters of the FDA Center for Devices and Radiological Health (CDRH) said the agency’s goal is to achieve safe, secure, and reliable deployments of wireless technology in health care.  As a result, the FDA more interested in the iPhone use by licensed medical professionals.  Mobihealthnews.com reports that Witters has defined a medical device as:

“…an implementation, product, apparatus or other component or accessory, which is used in the diagnosis, cure, mitigation, treatment, prevention of disease or effects any structure of the body–that could actually include some information technologies and performance technologies–but usually something that is performed on the patient, touches the patient or is performed between physician and patient.”

Can an iPhone achieve many or all of these uses and purposes?  Yes. It appears that an iPhone loaded with the proper apps is indeed a medical device of some sort.

If that’s the case, how should the FDA get involved in regulating the device? Witters said the FDA’s role is “to provide some reasonable assurance of safety and effectiveness in medical devices marketed in the U.S.”

mHealth apps developers as well as wireless medical device makers should contact the FDA to provide their views about how this emerging industry should be regulated.  For questions on this subject, or to provide an opinion, contact the FDA’s CDRH.  As regulations and roles are defined and categorized, so too will laws emerge regarding mobile devices and their medical use.

This post courtesy of The AppsLawBlog.  Come visit us here.

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To understand why Sen. John McCain introduced a bill on dietary supplements, read the press releases. The legislation announced Feb. 3  addresses public safety, but mostly it’s about the reputation and revenue of professional and Olympic sports.

The evidence: McCain says in the release that “a little over a year ago the NFL suspended six players, including two players from one of the teams competing this Sunday, for violating the league’s anti-doping policy.  Several of the players were surprised that they tested positive for a banned substance because they used a dietary supplement they believed to be safe and legal.”

McCain ends the release, “It is my hope that this legislation will ensure that all Americans, including athletes, have all the information necessary to make informed decision when choosing whether to use a dietary supplement, and that the FDA has the ability to remove any harmful dietary supplements from the market.”

What organization was first to endorse the legislation? Major League Baseball. Commissioner Bud Selig issued a statement supporting the bill and MLB.com reported on McCain’s announcement of the legislation.

Next on board: The U.S. Anti-Doping Agency, which issued a press release with an affiliated group, Supplement Safety Now. Its members include Major League Baseball, NFL, NBA, NHL, PGA, NCAA and other national sports organizations. All are powerful organizations inside and outside Washington. And they share a complaint: Their athletes have been unwitting victims of mislabeled supplements that caused disqualifications and suspensions.

In other words, the products were bad for business. The groups want to arm the FDA with the data to monitor supplements and the power to yank immediately the detrimental ones off the shelf. They found an ally in McCain, whose 2008 presidential campaign received substantial financial support from athletes and others in pro sports, ESPN reports.

The initial response from groups representing supplement makers and marketers was tepid. “Though we have not yet examined this bill completely, it places new burdens on dietary supplements that are not required for any other class of food,” Michael McGuffin, president of the American Herbal Products Association said the third paragraph of a press release.

The last sentence of the third paragraph of a press release from the Council for Responsible Nutrition quotes CEO Steve Mister as saying, “The best way to help consumers is through collaborative efforts with industry, government and other stakeholders, such as USADA, to implement the current laws, to provide more resources and funding to FDA, and to pass the food safety bill, which already includes many of these provisions.”

As the bill moves from the headlines to the sidelines, look for an intense lobbying effort by sports organizations. Supplement-related scandals have hurt their reputations and wallets. They see a solution in increased federal action and will push hard for that.

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We often receive inquiries from companies looking for assistance with trademark matters.  For this very reason, we created a new form for use in submitting specific questions on trademark registrations.  To use our trademark form, click here.

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On the topic of the FDA and regulation of dietary supplements, I am quoted as saying:

“The fear was a Democratic administration was going to be 180-degrees different…But the measures taken have not approached the sort of draconian response a lot of folks in the industry feared.  That’s not to say things didn’t tighten, they did.”

David Ettinger Food Law Expert

Also quoted is food law expert (and college chum) David Ettinger of Keller and Heckman in DC.

Unfortunately, the link requires a subscription, but a 30 day trial is available.  To read the full article, click here.

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The Washington Post recently published an article asserting that vitamin D is shaping up to be the nutrient of the year, if not the decade. The article started factually strong but weakened at the end when it made specific recommendations.

The Post references an article in Consumer Reports titled “Most people get insufficient Vitamin D, but extra supplements may not be needed.” That article correctly notes that vitamin D blood levels in U.S. residents are on average below what is now thought by some experts to be what is needed for optimal health; the magazine perhaps overstates the case by writing that “…77% of Americans have insufficient amounts.”

In an article published last year in the American Journal of Clinical Nutrition, Elizabeth Yetley uses NHANES data to show approximately 6 percent of adults are below the traditional cut-off defining vitamin D deficiency and 77 percent are below what some nutritionists now opine to be the preferred target of 80 nmol/L.

The Consumer Reports article also points out what is putting the U.S. population at risk, primarily increases in obesity (fat sequesters some of the vitamin D synthesized in the skin) and less skin exposure to sunlight’s ultraviolet radiation.

The Institute of Medicine is currently reviewing the Dietary Reference Intake value for vitamin D, which was last updated in 1997. A final report is expected this May.  Currently, people 19 to 50 years of age are advised to consume at least 200  International Units per day,  those 51 to 70 at least 400 units, and those over 70 at least 600 units. Estimates are that adults get 100 to 150 units daily from food.

Consumer Reports goes astray when it writes: that people don’t need a special supplement; that overdosing is unlikely; and who should be advised to have their blood levels tested. Although makers of nutritional supplements are planning reformulations of their multivitamin products pending the institute’s report, most of what is on the shelves now is still at only 400 units.

What defines overdosing is up in the air. Officially, the Tolerable Upper Intake Level is 2,000 International Units per day. While bets are that the Institute will raise the adequate intake to 1,000 units per day, it is less clear whether the upper limit will also be increased. Writing in the American Journal of Clinical Nutrition, John Hathcock and his colleagues make a case for 10,000 units as a safe limit. The Institute has a conservative approach to upper limits.

Finally, people should not wait to get a blood test until they are diagnosed with weak bones or an absorption problem, contrary to what Consumer Reports says. Better advice would be for all adults to start taking 1,000 units per day from supplements. If you are in a higher-risk group for low vitamin D levels (obese, female, older, bypass surgery, Hispanic, African-American), get tested a few months later.

David A. Mark, Ph.D., is president of dmark consulting LLC, a science consulting company serving the dietary supplement and functional food industry. Contact him at david@dmarknutrition.com or 978-897-0890.

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Marketers of nutritional supplements often complain that they do not know what the FDA wants. Even after the agency sends a warning letter about misleading claims and advertising, its staff does not explain what would fall within the rules. That’s the reality; the FDA will tell you what’s wrong, not what’s right.

Through warning letters, the agency provides insight into how a marketer can fall afoul of the rules. Companies that examine why their competitors get chastised can apply the lessons to their Web sites, catalogs, labels and the like.  Washington attorney Ivan Wasserman looked at the 73 letters issued in 2009 (way, way up from 44 in 2008) and found that 72 related to claims on Web sites. Six involved claims made in metatags.

Lesson #1: The FDA is surfing the Web, checking not just product descriptions and benefits, but Googling for questionable SEO/SEM.

Wasserman’s list would rank the letters by claim problems in this order:

• Drug and disease claims: 72
• H1N1 virus claims: 37
• Other drug and disease claims: 20
• Heart disease and cardiovascular claims: 11
• Diabetes claims: 8
• Cold and flu claims (not H1N1): 8
• Cancer claims: 8

Lesson #2: The medical emergency that makes the most headlines gets the greatest scrutiny. In 2009, that was H1N1.

The FDA also sent 12 warnings letters related to claims made on labels and product labeling. Some of these may have echoed what was published on Web sites as manufacturers compounded their marketing errors.

Lesson#3: The FDA reads labels in the stores and on packages sent by mail. Adding an asterisked disclaimer to language on a label is no protection.

The FDA lived up to its announced commitment of greater enforcement and more scrutiny of the supplement industry. The agency could top the century mark in warning letters this year. Companies that have not recently reviewed their sites and labels would be wise to do so now before the mail carrier brings bad news.

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In a year when initial public offerings and acquisitions were almost unheard of, the supplement business saw many go public and get bought.  Only iPhone apps fared better, and not by much.

Meanwhile, the regulatory landscape tightened, but not as much as expected under a Democratic administration.  While both foods and drugs had their shares of scandals, supplement makers passed their early cGMP inspections and emerged unscathed.

Looking ahead to 2010 we envision many new challenges and opportunities for the supplement business.  In no particular order, here’s what to look for in the year ahead:

Sports supplements face stiffer regulation. Under several proposals currently being circulated in Congress, the Drug Enforcement Administration would be given increased powers to schedule substances that are chemically similar to or precursors of human growth hormone effectively banning them from use without a prescription.  Some sports supplement makers will need to reformulate their products or face enforcement action from DEA, an agency far more aggressive than the FDA supplement companies are used to.

CGMP regulations impact small supplement businesses. In June companies with 20 and fewer employees become subject to the FDA’s dietary supplement CGMP regulations.  Companies that rely on contract manufacturing will receive a rude awakening as they are subject to regulatory scrutiny they have never previously experienced.  Small supplement makers should begin to prepare themselves by implementing standard operating procedures to comply with the new cGMP rules.  Many will fail to do so and by year’s end fewer small supplement companies will be around to see 2011 as a result.

Investors get serious about supplements. Expect more merger and acquisition activity in 2010 with special emphasis on venture capital firms seeking new opportunities for profit in the supplement space.  Ingredient suppliers, contract manufacturers, marketers and retailers are all in play.

Regulators take aim at Internet supplement businesses. Armed with new rules and increased funding, regulators at the Federal Trade Commission, Food and Drug Administration and state attorneys general will step up their attack on supplements sold as drugs and deceptive and unfair sales practices.  The FTC endorsement rule will be used against bloggers and the companies that sponsor them.  Learn and follow the rules now or get caught violating them later.

By all accounts 2010 will be a great year to not just survive but thrive.  We hope to be there with you and look forward to your comments in the year ahead.

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Jin Hua Qing Gan Fang made in lab.

The rules are different here in the United States. Hyde Park Holistic Center in Cincinnati recently received a warning letter from the Food & Drug Administration that read like many others having to do with nutritional supplements and the H1N1 virus. In China, though, the same admonishment could not be heard.

First, the FDA’s message to Hyde Park, which operates the Web site drdahlman.com: “The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation. prevention, treatment, or cure of the H1N1 Flu Virus.”

The product in question is “4 Life Transfer Factor Plus Tri Factor,” which is sold in a password-protected store on the site. The product apparently supports immune system health or, as the FDA quotes Dr. Dahlman on one of his Web pages, “I firmly believe that use of this product will sufficiently upregulate your immune system and should be a primary part of your strategy to avoid the dangers of swine flu (H1N1 virus).”

It’s worth noting that Dr. Dahlman is not an M.D. His online biography says he is “a Chiropractic Physician with a degree in Nutrition, is Director of The Hyde Park Holistic Center in Cincinnati, Ohio and specializes in treatment of chronic health problems using nutritional, herbal and homeopathic therapies.”

If Dr. Dahlman were in China, he might have gotten praise rather than criticism. On Dec. 16, Chinese medical specialists said they had developed a Chinese herbal medication to treat H1N1. An article from the official Chinese news agency, Xinhua, quotes Wang Chen, president of Beijing’s Chaoyang Hospital, as saying the medication “can shorten patients’ fever period and improve their respiratory systems. Doctors have found no negative effects on patients who were treated in this way.”

The article adds that the herbal formula, called “Jin Hua Qing Gan Fang,” had been tested at 11 hospitals on 410 people who exhibited mild symptoms of H1N1. With success in treatment over a five-month period, the makers were seeking international patents.

The herbal medication is being positioned as a lower-cost alternative to Tamiflu, which WHO recommends for the treatment of H1N1.
Interestingly, the article quotes Cris Tunon, a senior officer at the WHO office in China, as saying that “WHO welcomes the clinical results.”

It’s unlikely the herbal medication would get the same greeting in the United States. The FDA has warned a number of companies with herbal products to stop making H1N1-related claims. Twice in 2009, the AHPA has advised against the use of dietary supplements to prevent or treat the flu. What happens when “Jin Hua” is marketed on American shores?

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