As more iPhone apps are released for medical purposes such as diagnosis and treatment of symptoms, Electronic Medical Records (EMR), and other health-related purposes, Apple‘s mobile device is garnering more attention from the FDA.

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.

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.

If you are an established supplement company looking for assistance with an intellectual property issue, or a brand new supplement firm trying to break into the market, we are here to help!

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.

Your’s truly is featured in a front page article in today’s National Law Journal by Jenna Greene entitled “Rule Reversal: Obama’s agencies after one year.”  The article provides a look at six key regulatory areas since Obama took office.

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.

GUEST POST BY DAVID MARK

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.

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.