Alaven Consumer Healthcare, Inc. manufactures and sells Colonix non-prescription herbal supplements and intestinal cleansers under its house brand DrNatura.  Alaven sued DrFloras LLC for trademark infringement, unfair competition, false advertising and other claims for using the trademark DrFloras for similar products.  The federal district court dismissed the infringement and unfair competition claims without trial because the judge decided that DrNatura and DrFloras were not confusingly similar trademarks. 

On appeal, the federal appeals court for the 11th Circuit concluded that the district court judge was right that there was insufficient evidence of likelihood of consumer confusion to require a trial.  Alaven Consumer Healthcare, Inc. v. DrFloras, LLC, No. 10-1131 (11th Cir., 10/12/2010).

Both companies have federal registrations and/or pending applications for their trademarks.  The marks look like this:

The side-by-side visual similarities are the “Dr” and “ra” elements of the marks and leaves in the design.  As a whole, however, they don’t have the same appearance, pronunciation or meaning and the district court judge thought they were reasonably distinct from each other. 

It is not unusual for trademarks for supplements to include “Dr” or a variation of “Natural” or “Nature.”  There are over 200 active registrations and pending applications for trademarks for supplements containing “Dr” and over 400 for marks containing variations of “Natural” or “Nature.” 

It looks like this case may have resulted from some tough marketplace competition between the products, which are similar and are marketed and distributed on the Internet to the same types of customers.  Without an obvious showing of bad faith or any evidence of consumers who were confused to tip the balance, Alaven did not have a strong enough case to go to trial.

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To read the latest issue, click here.

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Jonathan W. Emord, Esq.

Supplement lawyer Jonathan Emord has filed three important suits this summer challenging FDA administrative action on first amendment grounds.  The suits were all filed on behalf of long-time Emord clients Durk Pearson, Sandy Shaw, the Alliance for Natural Health, and the Coalition to End FDA and FTC Censorship.

The complaints in all three cases were filed in federal district court for the District of Columbia and are captioned identically.  The first suit challenges the FDA’s rejection of qualified health claims for supplements containing the powerful antioxidant and anti-carcinogenic selenium (the “Selenium Challenge”).¹  A second suit challenges the FDA’s rejection of qualified health claims for antioxidant vitamins C and E (the “C and E Challenge”).² The third suit challenges the FDA’s dietary supplement current Good Manufacturing Practice regulations (the “cGMP Challenge”).³

These plaintiffs and their lawyer are well known for making law in the Pearson/Whitaker Cases that has benefitted the supplement industry significantly over the past ten years.⁴. Since the court decisions that may emerge from the new Selenium Challenge, C and E Challenge, and cGMP Challenge cases could have a significant impact on the law regulating supplement formulators, manufacturers, and marketers, and the FDA’s interpretations of that law, we are providing more expanded coverage here of these potentially important cases.  Part I will address the Selenium Challenge and the Vitamins C and E Challenge, and Part II will follow in a separate blog post to address the cGMP Challenge.

The Selenium Challenge and the Vitamin C and E Challenge – Does the FDA disregard the law and Supreme Court precedent by suppressing commercial speech about supplements?

For anyone not acquainted with the herculean legal struggle undertaken by Emord and his clients in the Pearson/Whitaker series of cases, the Complaint in the Selenium Challenge is a worthwhile read and I commend you to it.  The point of all the billable hours invested in this struggle may seem elusive but is actually quite simple: force the government to limit its censorship of claims about supplements to the “least restrictive means” test articulated again and again by the US Supreme Court in commercial speech cases.⁵

What does this mean from a practical standpoint for supplement companies?  It means that if you have a claim to make about your ingredient or formulation, and that claim is supported by competent and substantial scientific evidence, you should be allowed to make that claim as long as the claim is not deceptive or misleading. Sounds simple, right?  Sounds like the good practice you are already following for structure-function claims, right?

Well, what if that claim is a disease claim, like a claim that says “take this supplement and you may be able to prevent yourself from cancer.”   That’s not a DSHEA structure-function claim.  On the contrary, that’s the holy grail of supplement marketing, a claim that the FDA would say makes your product an unapproved drug and subjects you to prosecution for violation of the Food, Drug and Cosmetics Act.

Emord’s victories in the Pearson/Whitaker Cases paved the way for such claims, and required the FDA to create a new category of claims called “Qualified Health Claims.”  Qualified Health Claims are claims with disclaimers that provide a balanced view of the scientific evidence available to support a particular supplement’s impact on a specific disease state by incorporating a disclaimer that makes it clear to the consumer that the “jury is still out” on the ultimate conclusion suggested by the claim, but at the same time gives the consumer solid information to make critical purchase decisions.⁶

Fast forward several years to the emerging body of evidence developing around the powerful anti-carcinogenic effects of selenium.

Selenomethionine - an amino acid containing selenium.

This body of evidence shows significant correlation between selenium intake and the reduction in risk for certain cancers including cancers of the prostate, lung, respiratory tract, colon, and digestive tract.  Is the evidence conclusive?  No.  But is it powerful and supported by valid studies using recognized methods and conducted by reputable scientists?  Yes.

In reliance upon the body of evidence developed, Pearson and Shaw petitioned the FDA for approval of five qualified claims for selenium.⁷  Four out of the five claims were rejected outright.  A fifth claim, for prevention of prostate cancer, was saddled with disclaimers that were so onerous it was almost not worth making since the disclaimer was so long you could barely even fit it on the box or bottle with the supplement.

Some perspective is valuable here: FDA reviewed 233 studies in the course of its review of the challenged claims.  Pearson and Shaw submitted 77 studies as supportive of their claims.  According to the Selenium Challenge complaint, almost all the evidence submitted was ignored by FDA.  To their credit, Pearson and Shaw acknowledge that the evidence is not conclusive, but they do seem to have the weight of the credible scientific evidence on their side, much of which is detailed in the Selenium Challenge complaint complete with citations to the literature.

Pearson and Shaw also petitioned the FDA for approval of qualified claims for the antioxidant effects of Vitamins C and E.⁸  The claims consisted of ten Vitamin C qualified health claims and 7 Vitamin E qualified health claims involving the relationship between Vitamins C and E and the reduction in the risk for cancer. In support Pearson and Shaw submitted over 200 scientific publications demonstrating a nutrient-disease relationship between vitamins C and E and site-specific cancers.

Pearson and Shaw had hope that at least some of their claims might be approved.   However, in the interim, the FDA issued its guidance document, “Evidence-Based Review System for the Scientific Evaluation of Health Claims.” In this guidance document, according to the C and E Challenge, the FDA mucked up the analysis required for qualified claims by conflating it with the higher standard set for FDA Approved Claims. Once again, FDA rejected most of the proposed qualified claims, and for the ones that it accepted it rewrote them and included so much negatively laden verbiage as to make the claims unusable.

Both these challenges seek to reorient FDA thinking (to put it mildly) as it pertains to the qualified claims review system.  Emord clearly hopes that the D.C. Circuit will take FDA to task for its failure to comply with past decisions requiring it to lift excessive burdens on the free speech rights of supplement marketers so that consumers can be fully informed about developing science behind powerful dietary therapies available to treat and prevent disease.  We will see in Part II of this post how the new cGMP system also places burdens on the commercial speech rights of supplement makers, so stay tuned…

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1. Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01470-ESH, Aug. 4, 2009, Huvelle, J.
2. Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01546-RJL, Aug. 14, 2009, Leon, J.
3. Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01523-CKK, Aug. 12, 2009, Kollar-Kotelly, J.
4. See, e.g., Pearson v. Shalala, 98-5043 (D.C. Cir. Jan. 15, 1999) and Whitaker v. Thompson, 03-5020 (D.C. Cir. Jan. 9, 2004)
5. See, Central Hudson Gas & Elec. v. Public Svc. Comm’n, 447 U.S. 557 (1980)
6. See Guidance for Industry: FDA’s Implementation of “Qualified Health Claims”: Questions and Answers; Final Guidance  (29 August 2009)
7. Selenium and a Reduced Risk of Site-specific Cancers, FDA-2008-Q-0323
8. Petition for Qualified Health Claims: Antioxidant Vitamins C and E and Reduction in the Risk of Site-Specific Cancers, FDA-2008-Q-0299

A recent study by LegalMetrics, a litigation analysis firm, named the Southern and Middle Districts of Florida among the top five districts for speed to resolution in patent infringement cases.   Since Florida has not been known as a “rocket docket” in the past, these results may seem surprising.  However, for intellectual property litigation attorneys, the recognition that Florida offers a favorable forum for facilitating the resolution of cases in a timely manner is nothing new.

The Southern District (in yellow) and the Middle District (in green) cover all Florida’s major population centers.  A survey we performed of filings of intellectual property cases in popular federal districts including these Florida Districts reveals that, with the exception of the Eastern District of Virginia, filings of IP cases have trended downward in the last several years.  Of course, fewer cases filed mean more attention for filed cases from the federal judges assigned to those cases.

Decisions in IP cases issued in early 2009 further suggest IP owners receive favorable treatment from Florida district court judges.  Among these decisions were the following:

• In a trademark infringement case filed in the Southern District of Florida, district judge Daniel T. K. Hurley denied the defendant’s motion to dismiss finding that the plaintiff trademark licensee had standing to prosecute infringements even though it was not the trademark owner.  In the process, the court adopted a liberal interpretation of standing for Lanham Act claims favorable to plaintiffs. See Trump Plaza of the Palm Beaches v. Rosenthal, Case No. 08-80408 (Jun. 24, 2009) .
• In a patent infringement case filed in the Middle District of Florida, district judge Steven D. Merryday dismissed counterclaims for unjust enrichment as preempted by federal patent law. See Mayo Clinic of Jacksonville v. Alzheimer’s Institute of America, Inc., Case No. 8:05-cv-839 (Jun. 26, 2009).
• In a patent infringement case filed in the Southern District of Florida, district judge James I. Cohn denied the defendant’s motion to dismiss and held that the plaintiff had standing to sue for infringement based upon an agreement with the original inventor in England signed before the patents were ever filed in the United States. See Flexiteek Americas, Inc. v. Plasteak, Inc., Case No. 08-60996 (Jun. 14, 2009).

Other cases demonstrate a willingness among Florida district judges to find personal jurisdiction over defendants based upon very minimal contacts including activities on the Internet.  Recent decisions have indicated that Florida courts will follow liberal standards for jurisdiction where simply maintaining an interactive website accessible on the Internet from Florida will subject a defendant to personal jurisdiction in the Sunshine State.

The moral of this story: when considering where to file an infringement action, intellectual property owners, including owners of trademarks, copyrights and patents, as well as counsel for these owners, would be wise to consider filing in the Southern or Middle Districts of Florida.  Of course, IMHO, my firm Arnstein & Lehr LLP, with its vast Florida litigation resources and experience prosecuting infringements would be an excellent choice to partner with as knowledgeable counsel for such cases.

PR: wait… I: wait… L: wait… LD: wait… I: wait… wait… Rank: wait… Traffic: wait… Price: wait… C: wait…

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After an FDA warning letter told True Renewal to either register its products with the agency or change claims on its Web sites, the supplement maker has altered product descriptions. The FDA targeted five products, saying the Web sites claimed the items could be used to cure, treat or prevent disease.

Product descriptions on the Web site now differ from the FDA citations. For one product, Miracle Mineral Supplement, the FDA said that True Renewal claimed, “Hundreds of lives have been saved. Reports of overcoming incurable diseases are happening every day.”  The product page for the supplement now reads in part, “Any information provided herein is for educational purposes only and is NOT meant to diagnose, treat, cure or prevent disease.” The home page for Miracle Mineral Supplement also has this disclaimer: “The Miracle Mineral Supplement is not FDA approved and is not intended for human consumption.”

Similarly, the FDA said the company had claimed that Graviola contained compounds “that are 10,000 times stronger than chemotherapy and act only on cancer cells, not healthy cells!” Now, the Web page for Graviola lists ingredients, contraindications and drug interactions.

True Renewal is based in Provo, Utah. Three Web pages providing company and contact information list street and e-mail addresses, and a fax number. The FDA addressed its warning to Jenine M. Cohoon. According to one biography, she holds a Ph.D. in holistic nutrition. Her Web site, which the FDA cited in its letter, now has no content and points to True Renewal.

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Hansen sought to bar VPX from making claims that its Redline Power Rush beverage and two ounce shot product provides “7 Hours of Pure Energy,” “7 Hours of Sustained Energy,” and “No Crash.”

The California federal district court however refused to enter an injunction against Hansen finding that, among other things, Hansen’s evidence was insufficient to support a preliminary injunction at the early stages of the proceeding.  To read the decision, click here.

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The purpose of recording a trademark or copyright with U.S. Customs is to partner with U.S. Customs to prevent the unauthorized importation of merchandise which bears a recorded trademark or copyright. U.S. Customs prevents counterfeit products from entering or exiting the United States when registered trademark holders record their trademarks or copyrights with U.S. Customs.

To read the article, click here.

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But is Nature Made made by nature? Not necessarily, says Miami lawyer and Nature Made customer Paul Bass. And so Mr. Bass, using a defunct corporation he owns called Pinecrest Consortium, Inc., is suing Pharmavite claiming they violated the Florida Deceptive Trade Practices Act by tricking him into believing that the synthetic Vitamin E he purchased under the trademark Nature Made was actually from natural sources.

Made by man, or made by nature?

As with many vitamin supplements, some found on store shelves are derived from natural sources and others are made in the laboratory. Most natural vitamins are indistinguishable from their synthetic counterparts since they have identical molecular structures.

However, the natural and synthetic forms of vitamin E are different. According to this research summary from supplement ingredient maker Cognis entitled “A Comparison of Natural and Synthetic Vitamin E,” natural vitamin E, derived from vegetable oils, is identified in supplements as d-alpha-tocopherol. Synthetic vitamin E, produced commercially by a chemical reaction of trimethylhydroquinone (TMHQ) with isophytol, is identified as dl-alpha tocopherol.

Depending on who you believe, the differences may not end there. Some studies, including the ones surveyed by Cognis, show that the bioavailability and absorbtion rates of natural forms of vitamin E is significantly higher than that of synthetic forms, and that natural vitamin E is retained longer in body tissues than the synthetic variety. However, according to the Nature Made FAQ on Vitamin E, “some studies have shown both natural and synthetic forms of vitamin E to be absorbed equally well, while other studies show that the natural form is slightly better absorbed in the body.”

Mr. Bass, however, appears to be in no mood to debate the issue. Angry that he was sold a synthetic vitamin under the Nature Made brand, he sued Pharmavite under Florida’s Little FTC Act. Lawyers for Pharmavite removed the case to Federal Court last month arguing that because Bass challenged the use of the Nature Made trademark, the matter presented a federal question arising under the Lanham Act and belonged in federal court.

“Creamo” and its progeny.

Believe it or not, the foundations for this dispute over vitamin E supplements extend to the very earliest cases on deceptive advertising. In 1919, just 5 years after the passage of the Federal Trade Commission Act, 15 USC § 41, et seq., the U.S. Supreme Court decided Brougham v. Blanton Manufacturing Co., 249 U.S. 495 (1919), and held that the use of a federally registered trademark could be a deceptive practice in violation of a consumer protection statute.

In Brougham, the Dept. of Agriculture challenged the use of the trademark “Creamo” to identify margarine that contained no cream because it “is deceptive and induces the belief that cream is a substantial ingredient of the oleomargarine.” The company contended that because the designation “Creamo” had been sanctioned as an appropriate trademark by the Patent Office (then part of the Interior Department) it could not be deceptive.

The Supreme Court disagreed.

The test of the product is the meat inspection laws, not the trade-mark laws, and therefore we are concerned with the action of the Department of Agriculture and not with that of the Interior Department. And so intimately is the case concerned with the action of the Department of Agriculture that the basic and dominant contention of the Government is that to the department is committed the power of determining the fact of the influence of the name and label of the company. In other words, the power of determining whether a trade name is “false or deceptive” given by the law to the Secretary of Agriculture is, when exercised, conclusive of the falsity or deception of the name.

Cases decided since Brougham have employed the same reasoning. Examples include the use of the term “mill” in a brand name for wheat flour where the seller of the flour was not the original grinder of the grain, N. Fluegelman & Co. v. F.T.C., 288 U.S. 212 (1933); the use of the registered mark “Satinmaid” to refer not to fabric made of silk, the yarn used traditionally in the making of satin, but to cotton, N. Fluegelman & Co. v. F.T.C., 37 F.2d 59 (2d Cir. 1930); the use of a registered mark for the greek red cross on a brand of paper towels and toilet paper, A.P.W. Paper Co. v. F.T.C., 149 F.2d 424 (2d Cir. 1945); and the use of the term “Gordon’s Detoxifier” to refer to a bizarre turbo-enema type contraption that appeared to pose more harm than good to the user’s intestines, Irwin v. F.T.C., 143 F.2d 316 (8th Cir. 1944).

Flash forward to 2006

All well and good, but in this day and age can a brand name, by itself, really be deceptive? Many still complain about labeling products that have MSG and other chemicals as “all natural.” However, consumers are way more sophisticated now than they were in the old days when the cases cited above were decided.

During a recent visit to my local CVS I examined the selection of vitamin E supplements in the Nature Made section. Both natural and synthetic products were offered. The containers with the naturally derived vitamin E were labeled “100% natural,” while the synthetic variety were not.

Notice of Removal (contains all state court filings including complaint), Pinecrest Consortium, Inc. v. Pharmavite, LLC.

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In an interesting twist related to a prior post on this blog, actor Joe Gannascoli, who plays Vito on the Sopranos, is now endorsing H57. Perhaps this has something to do with Gannascoli being dropped as the spokesman for Stacker 2?

Complaint, JEC Nutrition v. CPMC, District of New Jersey.

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