In The News

NEW “.EU” DOMAIN NAME REGISTRATION OPENS

The Time to Act is NOW!

The 25 nations of the European Union have opened a one time opportunity for EU and U.S. companies to register their trademarks as domain names using the new “.eu” web address system. This opportunity will be on a first come, first served basis commencing on December 7, 2005. Zackler & Associates, in association with our correspondent European intellectual property counsel, Gevers & Partners, can provide you with a turnkey service to secure “.eu” website addresses for your trademarks.

Here’s the deal. Commencing on December 7, 2005 and ending on February 6, 2006, companies with a CTM registration or a national trademark registration in an EU country can register an “.eu” domain name that matches the registered mark. Registration periods will be for one, three or five year periods and can be renewed. Registrations will be done electronically on a first-come basis through independent companies that will act as registrars and file the registration materials with the EU Registry. Gevers has established a registration company to serve the needs of its clients.

Registration costs will start at €625 for a one year registration of one domain name. Charges per domain name will decrease as the number and length of registrations increases.

In order to participate your mark(s) must have a CTM or national registration in an EU country. Pending registrations are not eligible for registration. But, if your mark doesn’t yet have a CTM or national trademark registration, not a problem. For an extra charge, Gevers will obtain a Benelux registration for your mark within 48 hours.

Don’t try this at home. U.S. companies cannot directly register their marks with an “.eu” domain name even if their marks already have a CTM or a national registration. In order to facilitate the “.eu” registration, Gevers & Partners has established a European company to act as your trademark licensee for the purpose of registration.

Registrations must be done perfectly. Any mistakes will result in the rejection of the application and there will be no opportunity to correct mistakes. Gevers & Partners has assured us that they are fully prepared to handle the “.eu” registrations on a turnkey basis.

Waiting until the last minute can cost you the opportunity to secure your “.eu” registration. So act now. If you’re interested, please contact us immediately for further details.

 

FDA Approves New Qualified Health Claims for Calcium Supplements

In response to petitions filed by Marine Bio Co. the  Food & Drug Administration has stated that it will exercise “enforcement discretion”  (FDA lingo for approve) for five qualified health claims pertaining to the consumption of calcium supplements and (a) colon/rectal cancer, (b) colon/rectal polyps, (c) hypertension, (d) pregnancy-induced hypertension, and (e) pre-eclampsia during pregnancy.    FDA rejected qualified health claims for calcium supplements and breast cancer, prostate cancer, kidney stones, and urinary stones.

FDA’s qualified health claim policy is discussed in detail in the Fall 2003 issue of our in-house publication Food & Marketing Law Update.   As discussed in the article, FDA has developed a scale, ranked “A” to “D,” in which it categorizes the scientific certainty of each health claim.  A claim ranked “A” satisfies FDA’s “significant scientific agreement” or “SSA” standard.   These types of claims are approved under FDA’s statutory rule making process and are not “qualified.”  “A” ranked claims are published in the Code of Federal Regulations once they have completed the regulatory approval process.

Health claims ranked “B,” “C,” and “D,” do not qualify under the FDA’s interpretation of the Food, Drug and Cosmetic Act for regulatory approval because they do not meet the SSA standard.   Claims are ranked “B” if the FDA concludes that the scientific evidence supporting the claim is not conclusive, “C” if it is limited and not conclusive and “D” if there is little scientific evidence supporting the claim.  Claims ranked “B,” “C,” or “D” have different qualifying language.

The model qualified calcium supplement claims that have been approved by the FDA are (we have also added the claim’s rank):

“Some evidence suggests that calcium supplements may reduce the risk of colon/rectal cancer, however, FDA has determined that this evidence is limited and not conclusive.”   (Rank “C”) 

“Very limited and preliminary evidence suggests that calcium supplements may reduce the risk of colon/rectal polyps.  FDA concludes that there is little scientific evidence to support this claim.” (Rank “D”)

“Some scientific evidence suggests that calcium supplements may reduce the risk of hypertension.  However, FDA has determined that the evidence is inconsistent and not conclusive.  (Rank “C”)

“Four studies, including a large clinical trial, do not show that calcium supplements reduce the risk of pregnancy-induced hypertension during the pregnancy. However, three other studies suggest that calcium supplements may reduce this risk.  Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of pregnancy-induced hypertension.”  (Rank “D”)

“Three studies, including a large clinical trail, do not show that calcium supplements reduce the risk of pre-eclampsia during pregnancy.  However, two other studies suggest that calcium supplements may reduce the risk.  Based on these studies, FDA concludes that is highly unlikely that calcium supplements reduce the risk of pre-eclampsia.”   (Rank “D”) 

Some of the qualifying language is not consistent.  For example the first claim uses the term “limited” and the third claim uses the term “inconsistent.”   This discrepancy, which is not major, may be due to the fact that different staff persons evaluated these claims.

Of greater interest are the last two claims.  Although we have ranked these as “D,” the lowest ranking, the stridency of the disclaimer suggests that there is an even lower, unacknowledged “E” rank.   From a marketing point of view these qualified claims suggest that the supplements are worthless for these intended health benefits. Why would any manufacturer want to use this type of qualified claim?

 

Allan Zackler Presents to World Obesity & Weight Loss Congress, Washington, D.C.

Allan Zackler made a presentation entitled “The Brave New World of Obesity: Can You Still Promote Your Products Without Risking Litigation or Regulatory Action?” at the just concluded World Obesity & Weight Loss Conference in Washington D.C. In addition to Allan’s presentation, the two day conference included presentations and speeches by representatives of the FDA, FTC and other federal agencies, pharmaceutical, dietary supplement, and food manufacturers, marketing organizations, financial institutions, and R&D companies.

Allan’s presentation focused on the current regulatory requirements for making nutritional and health claims about food products and dietary supplements, how the traditional federal regulatory model is evolving into a much more diversified and less uniform system of state and even local regulation, and how private legal action may shape the product formulation and marketing landscape in the future. Using some brief case studies, Allan looked at different marketing strategies that could succeed or fail in the currently evolving regulatory environment.

This PowerPoint presentation is intended for all segments of the food and dietary supplement industries. Please contact us if you would like to arrange for a private showing of Allan’s presentation in which he will focus on the issues most pertinent to your business.

Also, click here for a description of three other presentations that we have available.