By Riëtte van Laack –

FDA published a proposed rule that would amend the regulation governing the use of health claims for phytosterols and coronary heart disease.  In 2000, FDA issued an interim final rule ("IFR"), 21 C.F.R. § 101.83, for health claims concerning the relationship between plant sterol/stanol esters and the reduced risk of CHD.  In 2003, the Agency issued a letter announcing that it would exercise enforcement discretion concerning certain claims that went beyond the claims permitted by the IFR ("2003 letter").  Since then, new evidence has become available concerning the effects of stanol and sterols in the esterified and non-esterified form (primarily evidence from numerous intervention studies), and FDA has received several requests for expansion of the health claim.  Because the public has not had a formal opportunity to comment on FDA’s proposed changes (as well as those announced in the 2003 letter), and because it has been ten years since the Agency published its IFR, FDA decided to issue a proposed rule rather than finalize the IFR. 

The proposed rule includes the following significant changes to 21 C.F.R. 101.83:

• A broadening of the substances eligible for the health claim for conventional foods to include any mixtures of esterified and nonesterified phytosterols (defined as inclusive of both sterols and stanols) derived from vegetable oils and tall oil.
• Removal of the restrictions on types of conventional foods eligible for the claim.
• Setting the daily dietary intake of phytosterols necessary to justify the claim for risk reduction at 2 g phytosterols per day.
• A requirement that food eligible for the claim contains 500 mg phytosterols per serving (provided that the phytosterols are GRAS at this use level).
• A requirement that the phytosterol-containing product must be consumed with meals or snacks.
• A limitation of the exception from the disqualifying fat level (13 g of fat per serving size or per 50 g of food) to vegetable oil spreads that resemble margarine, and inclusion of liquid vegetable oil in the short list of exceptions.
• The addition of liquid vegetable oils to the products exempt from the “minimum nutrient requirement” (i.e., foods eligible for a health claim must contain no less than 10% of the  Reference Daily Intake or Daily Reference Value for vitamin A, C, iron, calcium, protein or fiber per reference amount without nutrient addition).  Vegetable oil spreads resembling margarine may meet the minimum nutrient requirement by addition of vitamin A.

In the absence of valid scientific evidence, claims for dietary supplements remain limited to dietary supplements containing esterified phytosterols.  The requirement that conventional foods must be eligible for the claim “low in saturated fat” and “low in cholesterol” also remains.  

FDA did not propose a limit on trans fat content of food eligible for the health claim.  The Agency, however, requests input on the setting of a limit based on a single study that showed an effect of phytosterols in the presence of 0.8 g/day of trans fat. 

FDA notes that its proposal should not be interpreted as a statement that foods containing certain phytosterols do not violate § 301(ll) of the Federal Food, Drug and Cosmetic Act.  For more on the potential impact of section § 301(ll), click here.

FDA intends to exercise enforcement discretion with respect to claims that comply with the proposed rule.  However, beginning 75 days from December 8, 2010, FDA will no longer exercise enforcement discretion based on the 2003 letter.

Written comments may be submitted through February 22, 2011.

June Stephenson, a 37-year employee in FDA’s Office of Chief Counsel, will retire on December 31, 2010.   Ms. Stephenson has been the principal secretary for every chief counsel at FDA since 1974.  At a December 8th retirement party, her contributions were recognized by almost all of the nine chief counsels with whom she worked (including Hyman, Phelps & McNamara’s Tom Scarlett), and she received the Distinguished Career Service Award from the FDA Commissioner and a Certificate of Appreciation from the HHS Secretary.  The previous night, the Food and Drug Law Institute awarded Ms. Stephenson with a Lifetime Achievement Award. 

Those of us in the private sector who have dealt with the Office of Chief Counsel these past 37 years will miss her as much as her FDA colleagues.  We have appreciated the gracious professionalism she exhibited while dealing with us.  The courteous and intelligent face she presented to all with whom she came in contact enhanced FDA’s  reputation.  We wish her a long and happy retirement!

By Susan J. Matthees –

Last Tuesday, FDA announced the availability of final results from its experimental study of graphic cigarette warning labels.  As we previously reported, FDA proposed 36 graphic warning images to accompany the health warning statement required under section 201 of the Family Smoking Prevention and Tobacco Control Act.  As part of that process, FDA conducted a study of smokers ages 18 and older and youth ages 13 to 17 who were identified as being at risk for smoking.  Participants were divided into a control and a test group, with the control group seeing only the worded warning and the test group seeing the worded warning and the images.  After seeing the warnings or the warnings plus images, participants were asked about their reactions, related attitudes and beliefs about the risks of smoking, and intentions to quit or start smoking. 

The results of the study were mixed.  Although nearly every graphic image was associated with a higher emotional response than words alone and many of the images were associated with an increased recall of the message, only a few images actually had an influence on the participants’ beliefs about the health risks of cigarettes or the participants’ likelihood of quitting or not starting smoking.  In fact, some of the images were negatively associated with beliefs about health and behavior (i.e., participants were less likely to believe that smoking was dangerous or were less likely to consider quitting after viewing the image).  In its analysis, FDA opined that participants may need to see a certain “dose” of images before the images would have an actual impact on beliefs and behaviors.

The report made no conclusions on which images, if any, would ultimately be selected for use on cigarette labels.

By Kurt R. Karst –      

Earlier today, the U.S. Supreme Court granted certiorari in three cases concerning generic drug preemption - PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501).  As we previously reported, the petitions presented almost identical questions for the Supreme Court’s consideration: “Whether the Eighth Circuit [, in its November 27, 2009 decision in Mensing v. Wyeth, Inc.], abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the FDA-approved labeling for the listed (or branded) drug.”

The Court decided to hear the cases notwithstanding a recommendation from the U.S. Department of Justice (Solicitor General of the United States), which filed an amicus brief in November, that the Court deny review given the current lack of a split of authority among the circuits on the issue of preemption and state law failure-to-warn claims against generic drug manufacturers, as well as several uncertainties in Mensing that “further counsel against review at this time.”

By Alan M. Kirschenbaum –

Individuals may have their tax cuts extended, but a new tax on the drug industry is about to begin in 2011, and the IRS has issued a notice to implement it.  As we explained in our summary of the Patient Protection and Affordable Care Act ("ACA"), the ACA imposes an industry-wide tax on companies that manufacture or import branded prescription drugs or biologics (i.e., those approved under an NDA or BLA) for sale in the U.S.  The aggregate annual fee for all such companies is specified in the statute, and ranges from $2.5 billion to $4.1 billion each year, then remains at $2.8 billion in 2019 and subsequent years.  Each manufacturer’s share of the fee is based on the ratio of its branded drug sales to the branded drug sales of all covered entities during the prior year.  Branded drug sales are sales of brand (i.e., NDA or BLA) prescription drugs (excluding orphan drugs) made to or reimbursed by Medicare, Medicaid, the Department of Veterans Affairs ("VA"), the Department of Defense ("DoD"), and the TRICARE retail pharmacy program. 

On November 27, the IRS issued Notice 2010-71 explaining how the drug industry fee will be implemented.  Although the statute specifies that the fee is to be based on sales during the prior year, the Notice explains that CMS is unable to provide data on Medicaid and Medicare drug utilization during a calendar year in time to set the fee for the following year.  Therefore, the sales used to establish the fee for any calendar year will be sales for the second year preceding the fee year – in other words, the sales data will be two years old.  To address the problem of basing the fee on data that is somewhat stale, the IRS proposes an adjustment to the fee that is derived from the increase (or decrease) in a company’s sales from the third to second year preceding the fee year.  Perhaps the IRS reasons that, if a drug’s sales increased (or decreased) between those two years, this justifies a presumption that sales continued to increase (or decrease) from the second to the first year preceding the fee year, so that the sales data from the second preceding year should be adjusted upward (or downward) to set the fee.

The Notice describes how sales to the VA, DOD, Medicaid, and Medicare Parts B and D will be calculated.  A company’s sales will be reduced by rebates the company paid to Medicaid (i.e., the Medicaid rebate but not Medicaid supplemental rebates) and Medicare Part D plans. 

Issued with the Notice was Form 8947, which covered manufacturers must submit to the IRS by January 20, 2011 to provide corporate information and data on orphan drugs, rebates paid to Part D plans, and other drug information.  The IRS will then provide each covered manufacturer with a preliminary fee calculation by May 2, 2011.  Comments on the Notice will be accepted until June 2, 2011, after which a final Notice will be issued.  A final fee calculation (taking into account any methodology changes) will be sent to manufacturers by August 15, 2011.

This week, the Republican Steering Committee selected Congressman Fred Upton (R-MI) to succeed Congressman Henry Waxman (D-CA) as Chair of the House Energy and Commerce Committee in the next Congress.  In August 2008, at the Democratic National Convention in Denver, Hyman, Phelps & McNamara’s Frank Sasinowski, the current chairman of the National Organization of Rare Diseases ("NORD"), had the idea to start a Congressional caucus on rare and neglected diseases in order to have a forum for issues that matter to the more than 25 million Americans with rare or orphan disorders.  Frank approached Rep. Waxman in Denver and broached the idea, which Rep. Waxman immediately supported.  Fast forward: NORD took up the idea and championed the creation of this caucus.  In forming this caucus, John Crowley, CEO of Amicus Therapeutics, (the subject of the film "Extraordinary Measures" as portrayed by Brendan Fraser), was "extraordinarily" instrumental.  Frank suggested to John that Cong. Upton be asked to co-chair the caucus.  Rep. Upton along with co-chair Rep. Joseph Crowley (D-NY) (no relation to John), announced the formation of the caucus this past July.  Now, Rep. Upton will be chairing the committee that has jurisdiction over FDA.  Orphan ideas are blossoming in December in DC!

By Ricardo Carvajal –

The D.C. Circuit Court of Appeals upheld the D.C. District Court’s grant of an injunction that bars FDA's regulation of e-cigarettes as drug/device products absent claims of intended use to that effect (for our prior posting on the district court decision, see here). Finding that the breadth of FDA’s authority under the FDC Act (as opposed to the Family Smoking Prevention and Tobacco Control Act, or Tobacco Act) is governed by the Supreme Court’s decision in FDA v. Brown & Williamson, the appellate court interpreted that decision to preclude FDA from regulating all tobacco products as customarily marketed – not just those tobacco products that were the subject of federal legislation at the time Brown & Williamson was decided.

FDA argued to no avail that the appellate court’s interpretation of Brown & Williamson would hamper the agency’s efforts to address potential risks posed by e-cigarettes. The appellate court noted that "the Tobacco Act gives the FDA broad regulatory authority over tobacco products, including, for instance, authority to impose restrictions on their sale, and on the advertising and promotion of such products, to regulate the mode of manufacture of tobacco products, and to establish standards for tobacco products" (citations omitted). In summary, the court concluded:

Together, Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate customarily marketed tobacco products under the FDCA’s drug/device provisions, that it can regulate tobacco products marketed for therapeutic purposes under those provisions, and that it can regulate customarily marketed tobacco products under the Tobacco Act.

FDA must now decide whether to continue its quest to regulate e-cigarettes (and possibly other less traditional products derived from tobacco) as drugs/devices, or to content itself with regulating them under the Tobacco Act.

The Washington Legal Foundation recently published an article written by HPM attorneys, Ricardo Carvajal and Nisha P. Shah, on the February 2010 Government Accountability Office ("GAO") report that criticized FDA's general oversight of uses of ingredients that are generally recognized as safe (“GRAS”) and the agency's voluntary GRAS notification program.  The GAO report identified several gaps in FDA’s current approach, and recommended tighter oversight of industry GRAS determinations.  However, the GAO gave short shrift to the drain on resources that would result from implementation of its recommendations, and failed to acknowledge the GRAS regime’s important role in fostering innovation in the food supply.

By William T. Koustas –

The Red Flags Rule (“the Rule”) requires entities covered by it to establish and implement an identity theft prevention program.  We have been following this issue for some time now and have previously reported that the FTC last delayed enforcement of the Rule to December 31, 2010 at the suggestion of members of Congress.  It took up legislation in an effort to better define the entities covered by the Rule.  Congress has now passed the Red Flag Program Clarification Act of 2010 (“the Act”) that amends the Fair Credit Reporting Act (“FCRA”) to more clearly define who the Rule applies to.  Prior to this legislation being passed, the FTC determined that the Rule applied to a variety of entities that are not generally considered creditors, such as legal and medical practices, simply because they usually bill clients after the services are rendered. 

The FCRA currently applies to creditors as defined in the Equal Credit Opportunity Act (“ECOA”) which defines a creditor as “any person who regularly extends, renews, or continues credit; any person who regularly arranges for the extension, renewal, or continuation of credit;” or “any person…who participates in the decision to extend, renew or continue credit.”  ECOA § 702(e).  The FTC interpreted this definition to apply to any entity that regularly bills customers or clients for services rather than requiring payment at the time the service is rendered.  This effectively meant that companies and professions were creditors, although they had never considered themselves creditors before.  As creditors, the Rule required that they create and implement a written program to prevent and mitigate identity theft. 

However, the Act would amend the FCRA to clearly state that the definition of a creditor, for the purpose of the Rule, “does not include a creditor…that advances funds on behalf of a person for expenses incidental to a service provided by the creditor to that person.”  Act § 2(a)(4).  Therefore, billing customers or clients for services rendered would no longer be a basis for treating an entity as a creditor for the purpose of the Rule.  We presume that the President will sign the Act before the end of the year.

By Kurt R. Karst –      

Speculation was running high that the U.S. Supreme Court would be petitioned on whether a patent settlement agreement (what opponents call “pay-for-delay” agreements or “reverse payments”) involving manufacturers of Ciprofloxacin HCl (CIPRO) is per se lawful under the Sherman Act after the U.S. Court of Appeals for the Second Circuit denied earlier this year a Petition for Rehearing and Rehearing En Banc filed on behalf of certain plaintiffs-appellants in In Re Ciprofloxacin Hydrochloride Antitrust Litig.  That Petition for Writ of Certiorari was filed with the U.S. Supreme Court earlier this week.

As we previously reported (here and here), in September 2010, the Second Circuit denied without comment a Petition for Rehearing and Rehearing En Banc that a panel of the judges on the Court invited in their April 2010 decision affirming (3-0) a 2005 decision by the U.S. District Court for the Eastern District of New York granting summary judgment for defendants (i.e., Ciprofloxacin HCl manufacturers) (In re Ciprofloxacin Hydrochloride Antitrust Litig., 363 F. Supp. 2d 514 (E.D.N.Y. 2005)).  In the April decision, the Court affirmed the district court decision because the Court believed its 2005 decision in Joblove v. Barr Labs., Inc., (, compelled it to do so.  According to the Court, “[s]ince Tamoxifen rejected antitrust challenges to reverse payments as a matter of law, we are bound to review the Cipro court’s rulings under the standard adopted in Tamoxifen.”  The Department of Justice and the Federal Trade Commission (“FTC”), which has been a vocal opponent of patent settlement agreements, filed amicus briefs in the Cipro case advocating that the Second Circuit grant rehearing en banc and apply an “inherently suspect” standard to patent settlement agreements, under which such agreements would be considered presumptively unlawful, but could nevertheless be proven to be procompetitive.  (This standard is similar to that in legislation introduced in Congress to address patent settlement agreements.)  The government is sure to actively support the petition to the U.S. Supreme Court.

According to the Petitioners, a group or purchasers including Louisiana Wholesale Drug Company, Inc. and Arthur’s Drug Store, Inc.:

This Court has repeatedly “emphasized the necessity of protecting our competitive economy by keeping open the way for interested persons to challenge the validity of patents which might be shown to be invalid.”  The Second Circuit nevertheless held, contrary to the decisions of three other circuits and the views of the United States and the [FTC], that, except in very limited circumstances, a pharmaceutical patentee may lawfully pay a generic drug manufacturer to forgo judicial testing of the patent’s validity and stay out of the market.  The Second Circuit’s decision cannot be squared with those of other circuits or with this Court’s prohibition on patentees “muzzling” those who otherwise would have an “economic incentive to challenge the patentability of an inventor’s discovery.” . . . .

The Court should grant review to resolve the circuit split, reject the Second Circuit’s precedents that favor judicial testing of patent validity, and restore the Hatch-Waxman Act balance by prohibiting brand manufacturers from paying competitors to forgo judicial examination of patents and thereby preserve unwarranted monopolies. [(internal citations omitted)]

The circuit split over the proper standard for determining whether an exclusion payment is actually a three-way split. . . .

The Sixth Circuit and the D.C. Circuit have adopted (and the FTC has applied) a “patent strength” standard, “which bases the but-for amount of competition on the patent litigants’ own view of the likely outcome of the litigation, as reflected in their objective conduct,” according to the petition.  This standard was applied by the Sixth Circuit in In re Cardizem CD Antitrusty Litig., 332 F.3d 896 (6th Cir. 2003), relied on by the D.C. Circuit in Andrx Pharm. Inc. v. Biovail Corp. Int’l, 256 F.3d 799 (D.C. Cir. 2001), and applied by the FTC in an administrative proceeding – In re Schering-Plough Corp., F.T.C. Docket No. 9297 (Dec. 8, 2003). 

The Eleventh Circuit has rejected the “patent strength” standard and instead applies a “patent relitigation” standard, under which “it determines the amount of but-for competition by engaging in an ex-post judicial determination of the patent issues as part of the antitrust case,” according to the petition.  The Eleventh Circuit applied this standard in Valley Drug Co. v. Geneva Pharms., Inc., 344 F.3d 1294, 1303 (11th Cir. 2003) and in Schering-Plough Corp. v. Fed. Trade Comm’n, 402 F.3d 1056 (11th Cir. 2005). 

Finally, the Second Circuit and the Federal Circuit, which have rejected the “patent strength” standard and have refused to apply the “patent relitigation” approach, apply a “sham litigation” standard, under which “[t]hey have conclusively presumed for purposes of the antitrust case that the patent was valid, and thus that no competition was likely to result from the patent litigation, unless the patent was obtained by fraud or the patent cliam was a graud,” according to the petition.  This is the standard applied by the Second Circuit in Tamoxifen and Cipro, and by the Federal Circuit in In re Ciprofloxacin Hydrochloride Antitrust Litig., 544 F.3d 1323 (Fed. Cir. 2008).

The U.S. Supreme Court has previously denied certiorari in several of the cases mentioned above, but perhaps this will be the time that it is granted.

By Ricardo Carvajal –

As required by its Good Guidance Practices regulation, FDA published its annual guidance document agenda and request for comment on “possible topics for future guidance document development or revisions of existing [guidance documents].” 

Among the food-related topics that caught our eye are new dietary ingredient notifications, use of dietary guidance statements, calorie declaration (think FOP labeling), menu labeling, and effect of the use emerging technologies on the safety and regulatory status of ingredients and food contact substances (think nanotechnology).  It appears that the agency also intends to address the safety of nanoscale materials in cosmetics.

On the tobacco side, FDA is considering addressing rotational warning plans for smokeless tobacco, use of descriptors such as “light,” restrictions on distribution of cigarettes and smokeless tobacco to minors, “harmful and potentially harmful constituents,” and issues of interest to retailers such as training programs and civil money penalties.

As swimmers in the social media pool, we also note with interest that CDER will (hopefully) address the promotion of prescription drug products using social media tools.

By Kurt R. Karst –      

Does “federal law, which imposes a strict set of labeling requirements on manufacturers of Final Monograph [Over-the-Counter (‘OTC’)] drugs, including mandatory product warnings authored by the FDA, [preempt] state-law product liability actions premised on theories of failure to warn[?]”  That is the question posed by McNeil-P.P.C., Inc. (“McNeil”) in a recent Petition for Writ of Certiorari filed with the U.S. Supreme Court.

The petition stems from the tragic events of April 24, 1999, when 16-year old Armando Valdes, III collapsed during a roller hockey game.  Armando allegedly consumed McNeil’s OTC drug Tylenol Cold (and/or Tylenol Flu) containing pseudoephedrine for a head cold, along with a caffeinated beverage, the morning of the roller hockey game.  Doctors diagnosed Armando with having suffered a heat stroke and cardio-respiratory arrest which resulted in a brain injury, hypoxic ischemic encephalopathy, and left Armando completely disabled.

Armando and his parents filed a negligence and products liability suit against McNeil (as well as the hockey club and equipment vendor, which settled with the Valdes family) for Armando’s injuries.  They contend that McNeil’s product “increased the risk of heat-related illness and heart-related risks when ingested with caffeinated products and coupled with strenuous or athletic events in a hot environment like that of South Florida,” and asserted that McNeil’s failure to warn of these risks breached Florida state law requirements. 

McNeil asserted, among other affirmative defenses, federal preemption.  After discovery, McNeil moved for final summary judgment on federal preemption grounds – specifically, that “federal law, which governs [OTC] and non-prescription drugs, and the FDA’s labeling requirements, which did not require McNeil to include the risk of heat-related illness on the label, preempted the state law claims in the Valdeses’ complaint.”  The Circuit Court for Miami-Dade County agreed with McNeil and granted final summary judgment, finding that “implied conflict pre-emption applied because it would have been impossible for McNeil to comply with federal regulations that mandate the exact warnings for labels of all OTC pseudoephedrine-containing products (including those sold by McNeil) while also meeting state common law jury determinations of whether the FDA-crafted warnings were adequate.”  The Valdeses appealed the decision to the Third District Court of Appeal of Florida.

In December 2009, the Third District Court of Appeal of Florida reversed the final summary judgment for McNeill on the basis that the U.S. Supreme Court’s March 2009 decision in Wyeth v. Levine “controls the issue of federal preemption presented in this case.”   (In Wyeth, the Court ruled, by a 6-3 vote, in the context of a brand-name prescription drug, that FDA labeling approval does not preempt state laws.)  Although McNeil argued that Wyeth is distinguishable because it dealt with prescription drugs and not OTC drugs, the court disagreed with McNeil that “the distinction carries the weight to allow it to circumvent the reasoning of the Court in Wyeth.”  McNeil sought discretionary review of the Third District Court of Appeal’s decision by the Supreme Court of Florida; however, that petition was denied on August 2, 2010.

McNeil’s November 30, 2010 petition argues that the Court should grant review to “correct” Florida’s rejection of impossibility conflict preemption in a case where the law does not contain a provision permitting a manufacturer to unilaterally change its product labeling by adding a warning.  (Although we note that there are procedures to amend an OTC drug monograph).  According to McNeil:

In rejecting Wyeth's implied conflict preemption argument, this Court relied on specIfic statutes and regulations applicable to manufacturers of brand-name prescription drugs, which allow the manufacturer to strengthen product warnings without prior FDA approval, pursuant to a "changes being effected" ("CBE") procedure.  The appellate court in Valdes ignored the fact that prescription and OTC drugs are subject to differnt federal regulatory regimes.  The appellate court failed to recognize that federal laws applicable to manufacturers of OTC products do not provide a mechanism similar to the CBE procedure that would permit a manufacturer to unilaterally change the warnings on product labeling crafted by the FDA.

Under FDA’s regulations at 21 C.F.R. Part 330, OTC drug labeling “shall be stated in the exact language where exact language has been established and identified by quotation marks in an applicable OTC drug monograph regulation.”  In addition, FDC Act § 751 (National Uniformity for Nonprescription Drugs) provides that in general “no State or political subdivision of a State may establish or continue in effect any requirement” for an OTC drug “that is different from or in addition to, or that is otherwise not identical with, a requirement under [the FDC Act], the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).” 

In addition to the Florida court reading Wyeth “so broadly as to preclude the assertion of implied conflict pre-emption based on impossibility under any circumstances,” McNeil notes that Wyeth has been misapplied by other courts in the OTC drug context.  For example, McNeil cites the Seventh Circuit Court of Appeals’ August 2010 decision in Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010) concerning the preemptive effect of FDA’s decision not to add a warning to Children’s Motrin.  In that decision, Judge Posner cited Wyeth for the proposition that courts are free to hold “that state law requires warnings on the label of an [OTC] drug beyond what the FDA has required.” 

“Without preemption,” McNeil states, “OTC drug manufacturers would be deprived of the ability to rely on FDA’s directives as to matters that Congress delegated to the Agency and that fall within the Agency’s unique regulatory and scientific expertise.”  In addition, “[w]ithout pre-emption, McNeil, and all other OTC drug manufacturers, would be deprived of the ability to comply simultaneously with their federal and state obligations or even to ascertain what those obligations are without resort to litigation.”

Hyman, Phelps & McNamara’s Paul Hyman and Ricardo Carvajal recently published an article in Food Chemical News on the cost of inadequate substantiation of health-related claims made in the labeling and advertising of foods.  Although FDA appears reluctant to take an aggressive stance with respect to claim substantiation, FTC has forged ahead with a number of investigations of allegedly false or misleading advertising that have resulted in restrictive settlements – and the plaintiffs’ bar has taken notice.

By Ricardo Carvajal –

In a strongly worded opinion, a federal judge has ordered that genetically modified sugar beet stecklings (seedlings) planted pursuant to permits issued by USDA be pulled from the ground.  As we noted in a prior blog posting, USDA/APHIS was found in violation of the National Environmental Policy Act for deregulating Roundup Ready sugar beets without preparing an Environmental Impact Statement.  The agency’s subsequent decision to issue permits for the production of the stecklings was not well received by the presiding court.  Now that court has concluded that Plaintiffs have demonstrated a likelihood of irreparable harm from the production of the stecklings based on the potential for “significant risk of environmental harm” (including potential incidents of contamination), and the “significant procedural injury stemming from the NEPA violations.”  Finding Defendants’ and Intervenor-Defendants’ assertions of economic harm to lack credibility, and that the “legality of Defendants’ conduct does not even appear to be a close question,” the court granted Plaintiffs’ request for an injunction requiring that the stecklings be removed from the ground.  An appeal is certain.

By Ricardo Carvajal

No sooner had we blogged on Senate passage of the Food Safety Modernization Act than Roll Call reported that the bill might be doomed by a constitutional flaw – namely that § 107 of the bill proposes fees, and Article I, section 7 of the U.S. Constitution states that “all bills for raising Revenue shall originate in the House of Representatives.” The procedural complications that this flaw gives rise to, coupled with the rapidly approaching close of this Congress, could push further consideration of food safety legislation into the next Congress.