FDA Still Has Not Defined Gluten-Free After 3 Years

05/27/11

Currently, a label with the term “gluten-free” must be truthful and not misleading; however, there is no set definition provided by the FDA. The FDA has proposed that a food which bears the label “gluten-free” must not have more than 20 parts per million or more of gluten, which is the amount that can be reliably detected. The use of the label would be voluntary, meaning foods that are naturally gluten-free, such as milk or water, would not have to bear the label. Foods that would be prohibited from bearing the label are those which include barely, common wheat, rye, spelt, kamut, triticale, farina, vital gluten, semolina, and malt vinegar. Learn More

Proposed rulemaking by DEA will bring its regulations governing forfeitures in line with the Civil Asset Forfeiture Reform Act

05/27/11

The Drug Enforcement Administration (DEA) recently published a notice of proposed rulemaking regarding the consolidation of seizure and forfeiture regulations in the Department of Justice which will harmonize the regulations of the DEA, Bureau of Alcohol, Tobacco & Firearms (ATF) and Federal Bureau of Investigation (FBI) pertaining to the seizure and forfeiture of assets and bring those procedures for seizure and forfeiture under one regulation. That notice of proposed rulemaking can be found here. Generally, assets may be seized and forfeited to the government if they were used in violation of a law providing for forfeiture, are contraband, violate a regulatory statute, or are connected in some way to the laundering of monetary proceeds of a specified unlawful activity. Learn More

IRS’s Second Guidance on the Foreign Account Tax Compliance Act (FATCA) Leaves Many Questions Unanswered

05/26/11

As we previously discussed here, the Foreign Account Tax Compliance Act (FATCA) enacted in March 2010 imposes a 30 percent withholding tax on foreign banks who do not properly disclose accounts held by U.S. taxpayers. In its implementation of FATCA, the Internal Revenue Service (IRS) has issued two Notices providing guidance to those that are affected. As previously discussed in our blog, the IRS issued its first guidance regarding its implementation of FATCA in late 2010. In this original guidance, the IRS required foreign institutions to document every account regardless of whether it had documentation on file. Learn More

Drug Company Immunity A Possibility In North Carolina

05/23/11

The North Carolina legislature is currently considering a bill that would provide immunity from lawsuits for drug companies in cases where the drug product in question had received FDA approval. If passed, North Carolina would be only the second state to provide such immunity for drug manufacturers. Michigan, which passed a similar law in 2005, was the first state to do so. Learn More

DOJ Will No Longer Seek Chevron Deference for Revenue Rulings and Revenue Procedures

05/20/11

On May 7, 2011, the Department of Justice announced it will no longer argue for Chevron deference to apply to revenue rulings and revenue procedures. The announcement comes in the wake of the Supreme Court’s recent decision in Mayo Found. for Med. Educ. & Research v. U.S., 131 S. Ct. 704 (2011) in which the Court held all regulations should be analyzed using Chevron deference regardless of the agency which promulgated them. Learn More