On November 26, 2012, the FDA suspended Sunland, Inc.’s food facility registration. Sunland is the nation’s largest producer of organic peanut butter. The FDA acted under the Food Safety Modernization Act’s (FSMA’s) new suspension/revocation authority contained in Section 415(b) of the Federal Food, Drug, and Cosmetic Act (FDCA). FDA discovered salmonella contamination in Sunland’s operation […]
On Monday, December 3, 2012, in a 2-1 decision, the U.S. Court of Appeals for the Second Circuit ruled “that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.” See United States v. Caronia, — F.3d —, 2012 WL 5992141 (2d […]
In the POM Wonderful case, the FTC ALJ rejected FTC staff demands that certain claims there in issue had to be backed by at least two well-designed clinical trials or they would be deemed deceptive. The issue is before the full Commission and will be decided on January 18, 2013. Even if the full Commission […]
If you ask a consumer what makes a dietary supplement adulterated, he or she will say that it contains an ingredient or contaminant that makes it unfit for human consumption. That is, of course, the logical and historically plain meaning of the term adulteration, but that is not the meaning of adulteration FDA gives to […]
The FDA has rendered the labeling exemption in 21 USC 343-2 a dead letter through construction. That provision of the Dietary Supplement Health and Education Act was inartfully written but nevertheless designed by Congress to liberate dietary supplement companies from the prohibition on nutrient-disease claims in 21 USC 343 when they supplied independent scientific literature […]
Years ago when lawyers in the dietary supplement industry first began to clamor for the adoption of regulations to impose good manufacturing practice guidelines on the industry, I warned that this move would provide an FDA intent on destroying that industry the best means to achieve that objective. For decades the FDA through Republican and […]
Effective today the FDA is implementing the Food Safety Modernization Act registration requirements. Section 102(a) of the FSMA, which created 21 U.S.C. § 350d(a)(3), requires biennial registration renewals beginning October 1st and ending December 1st of each even-numbered year. The FDA’s updated food facility registration system became operational today and, so, FDA is now accepting […]
In an August 21, 2012 article available here, MassDevice.com reports on the Ron Paul’s new bill which aims to give doctors authority to authorize treatment with unapproved medical devices for patients who are terminally ill. We discussed the Compassionate Freedom Choice Act of 2012 in our previous post here. House Republicans Paul Broun (R-Ga) and […]
WASHINGTON, D.C.—On August 2, 2012, Rep. Ron Paul (R-TX14) introduced the “Compassionate Freedom of Choice Act,” H.R. 6342, a Bill designed to “allow the importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients who execute an informed consent document.” Rep. Paul Broun (R-GA10) and Rep. Richard Hanna (R-NY24) […]
On Tuesday, August 2, 2011, Emord & Associates filed comments with the FDA and Office of Management and Budget (OMB) concerning the FDA’s proposed collection of information through 75-day New Dietary Ingredient notifications. We previously reported on the FDA’s proposed New Dietary Ingredient (NDI) guidance here and here. Federal agencies frequently collect information from private […]
Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.
11808 Wolf Run Lane
Clifton, VA 20124
Telephone: (202) 466-6937
Telecopier: (202) 466-6938
