Virginia (202) 466-6937 | Arizona (602) 388-8899

AbleChild Seeks Release of Newtown Shooter’s Medical Records

On April 4, 2013, AbleChild.org filed an appeal with the Connecticut Freedom of Information Commission (FOIC) seeking release of Adam Lanza’s medical records held by the Connecticut Medical Examiner’s Office.  That appeal, prepared by Emord & Associates and filed by the Heitke Law Office (Rhode Island), contests the Connecticut Medical Examiner’s refusal to disclose the […]

FDA’s Personal Import Policy

Foreign pharmaceuticals, active pharmaceutical ingredients (APIs), and other regulated drug products are more accessible than ever before.  The internet fosters direct transactions between consumers and foreign retailers.  Many physicians and practitioners purchase products from foreign sources in their routine practice.  But certain drug products may not be “approved” for sale in the United States market.  […]

The FDA’s and FTC’s Reliance On Randomized Clinical Trials For Dietary Ingredients Is Impractical and Unethical

The FDA and FTC intend to require randomized clinical trials (RCTs) in support of promotional claims for dietary supplements and dietary ingredients.  That much is clear.  The FTC took that position in the recent POM Wonderful case, and the FDA memorialized that position in its Evidence Based Review System (EBRS).  In practice, the FDA will […]

FDA’s New Suspension Authority Under FSMA Supplants Adulteration Standards in Section 342(f)

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 […]

Second Circuit Invalidates FDA Regulation of Drug Advertising on First Amendment Grounds in Landmark Decision that Portends Far Reaching Effects

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 […]

Read Nutraingredients.com’s article on GMO Labeling: “How vulnerable is Proposition 37 to a legal challenge?”

Elaine Watson of Nutraingredients.com interviewed Jonathan Emord concerning a possible legal challenge to California’s Proposition 37 on First Amendment Grounds.  Read the full article here:  GMO labeling:  How vulnerable is Proposition 37 to a legal challenge?   Jonathan explained:  “The argument would be that proof of harm is lacking and thus that the state lacks a […]

FDA Commences Enforcement of FSMA Registration Requirements

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 […]

MassDevice.com: Ron Paul bill would allow docs to OK unapproved devices for terminal patients

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 […]


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.

Virginia (Firm HQ)

11808 Wolf Run Lane
Clifton, VA 20124
Telephone: (202) 466-6937
Telecopier: (202) 466-6938

Arizona

2730 S. Val. Vista Dr.
Bldg. 6, Ste 133
Gilbert, AZ 85295
Telephone: (602) 388-8899
Telecopier: (602) 393-4361