April 4, 2018 12:30–5:00 p.m.
“All Matters FDA” promises to be informative, focusing on the Food and Drug Administration’s top accomplishments across the food and drug law spectrum. Find out about “hot topics” and hear the latest from seasoned professionals.
Hear the Latest from these Experienced Invited Speakers:
Robert J. Durkin, Esq., M.S., R.Ph.—Deputy Director Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, Food and Drug Administration (FDA)
Charlene Fullmer, Esq.—Deputy Chief for Affirmative Litigation, Civil Division, United States Attorney’s Office, Eastern District of Pennsylvania
Kevin Spradlin—Intelligence Analyst, FBI, Washington D.C.
Matthew R. Noonan, Esq.—Compliance Officer, FDA Human & Animal Food Division
Stanley R. Milstein, Ph.D.—Former Acting Deputy Director (retired),, FDA Office of Cosmetics and Colors
Hooman Noorchashm, M.D.—Cardiac Surgeon, Phila., Pennsylvania
Roseann B. Termini, Esq.—Food and Drug Law Legal Scholar; National Speaker, Online FDA Law Courses, Widener University, Delaware Law Schoo
Registration fee: $75;
Students with valid school ID: Free
Registration form available at delawarelaw.widener.edu/fdacle
For questions or for accessibility or special needs requests,
contact Carol Perrupato at DelawareLawCLE@widener.edu or 302-477-2178.
Food and Drug Law Association of Widener University Delaware Law School Wednesday,
Check-in begins at 12:00 p.m.
Widener University Delaware Law School
Ruby R. Vale Moot Courtroom
4 CLE Credits available in DE and PA (including one ethics credit)
NJ attorneys can self-report with our Certificate of Attendance
Course materials will be distributed electronically.
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Please fax or mail this registration form to: Carol Perrupato, Widener University Delaware Law School, 4601 Concord Pike, Wilmington, DE 19803-0406 – fax number 302-477-2282. Questions or inquiries, please contact Carol Perrupato at 302-477-2178 or via email at email@example.com.
Although FDA regulates homeopathic remedies, enforcement has lagged especially in comparison with the popularity and increased use of homeopathic remedies . Finally in late 2017, FDA issued a draft guidance entitled “Drug Products Labeled as Homeopathic.”
The draft guidance explains how FDA expects to prioritize enforcement and regulatory action with respect to drug and biological products, labeled as homeopathic and marketed in the United States without the required FDA approval. Once the final guidance is issued, FDA will withdraw Compliance Policy Guide (CPG) 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed”, issued back on May 31, 1988.
What is homeopathy? The guidance defines homeopathy as follows: “Homeopathy is an alternative medical practice that has an historical basis in theory and practice first systematized in the late 1700s. Homeopathy is generally based on two main principles: (1) A substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses (known as “like-cures-like”) and (2) the more diluted the substance, the more potent it is (known as the “law of infinitesimals”).”
The definition of “drug” in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 321(g)(1)) includes articles recognized in the Homeopathic Pharmacopoeia of the United States (HPUS) or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs. Senator Royal Copeland, was a physician and homeopathic proponent and finally a major sponsor of the 1938 FDCA.
What does the guidance state about enforcement? According to FDA, the agency recognizes resource limitations and intends to apply a risk-based enforcement approach to drug products labeled as homeopathic and marketed in the United States without the required FDA approval. Further, FDA expects to apply a risk-based enforcement approach to the manufacturing, distribution, and marketing of drug products labeled as homeopathic. Categories include:
Products with reported safety concerns;
Products that contain or purport to contain ingredients associated with potentially significant safety concerns;
Products for routes of administration other than oral and topical—For example, unapproved injectable drug products and unapproved ophthalmic drug products pose a greater risk of harm to users due to their routes of administration;
Products intended to be used for the prevention or treatment of serious and/or life- threatening diseases and conditions;
Products for vulnerable populations; and
Products deemed adulterated under the Food, Drug and Cosmetic Act.
https://www.federalregister.gov/documents/2017/12/20/2017-27157/drug-products-labeled-as-homeopathic-draft-guidance-for-food-and-drug-administration-staff-and Federal Register Vol. 82, No. 243 (December 20, 2017) Notices 60403
Update-Sentences Affirmed on January 23, 2018 Corp. Executive Liability Sentence Largest Ever in Food Safety History
AFFIRMED: See: United States v. Parnell, et. al, No. 15-14400 (11th Cir. Jan. 23, 2018) Click on the link for the appellate court decision. Court of Appeals Opinion
Former Peanut Corporation of America (PCA) President and Owner Stewart Parnell received a criminal prison sentence of 28 years in connection with the 2009 salmonella poisoning outbreak of 700 reported cases in 46 states. Expert evidence presented at trial detailed that there were nine deaths linked to PCAs tainted products. Parnell’s brother Michael received a 20 year prison sentence. The Quality Assurance employee received a 5 year sentence. They were sentenced based on their roles at PCA by shipping salmonella-positive peanut products and by falsifying microbiological test results. A federal jury convicted the Parnell brothers in September 2014 on several counts of conspiracy, mail and wire fraud as well as selling misbranded food. Stewart Parnell was also convicted for introducing adulterated food into interstate commerce. Stewart Parnell and Quality Assurance Manager Mary Wilkerson were also convicted of obstruction of justice. According to U. S. Justice Attorney Moore, “The sentence that was handed down today [Sept. 21, 2015] means that executives will no longer be able to hide behind the corporate veil”. The direct link to the sentences in the Parnell Salmonella Tainted Peanut Product case is below and court of appeals opinion above.
AFFIRMED: See: United States v. Parnell, et. al, No. 15-14400 (11th Cir. Jan. 23, 2018 (affirmed)). Click on the link Court of Appeals Opinion
SAVE The DATE: March 21, 2018 from 1pm-4pm
The Annual FDA Matters Conference at the Delaware Law School, Wilmington DE
Learn from seasoned professionals from FDA, FBI and the U. S. Office of the Attorney General
Focus: Opioids, Medical Devices, Food Safety, Dietary Supplements, Criminal Cases and Other Matters FDA—Year in Review, Top Notables, and Looking Forward
In Brief : This “All Matters FDA” promises to be informative and related to the Food and Drug Administration’s top accomplishments across the food and drug law spectrum.
Warning letter issued to Nashoba Brook Bakery, LLC
- ” ‘Love’ is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.”
- Link below
The following is from the FDA website which posts the company’s announcement as a public service.
“Death Wish Coffee Co. (“Death Wish”), the Round Lake, N.Y.-based Coffee producer known for producing the ‘World’s Strongest Coffee’, has initiated a recall its 11-oz Death Wish Nitro Cold Brew cans.”
“Death Wish in conjunction with an outside Process Authority has determined that the current process could lead to the growth and production of the deadly toxin, botulin, in low acid foods commercialized in reduced oxygen packaging.”
Mesh Implant Verdict
A Pennsylvania jury awarded $57.1 million in the allegedly defective pelvic mesh lawsuit against J&J’s Ethicon, Inc. The award includes $50 million in punitive damages and $7.1 million in compensatory damages. The trial was held in the Philadelphia County Court of Common Pleas mass tort program over allegedly defective pelvic mesh implants which were sold by Ethicon Inc. Stay tuned for the appeal by J&J.
Ebaugh et al. v. Ethicon Inc et al., (Ct. Common Pleas Phila., PA, No. 130700866, 9/07/2017). http://reut.rs/2gQR7Lr
Back in 2012 Beef Beef Products Inc. brought a lawsuit against ABC in a multibillion-dollar defamation claim.
According to the lawsuit, the product, described by Beef Products Inc. as “lean finely textured beef,” was described by ABC as “pink slime” numerous times. The trial started June 5, 2017. The complaint had alleged damages of $1.9 billion dollars. Under South Dakota’s Agricultural Food Products Disparagement Act, this amount could have been tripled to $5.7 billion. The terms of the settlement are confidential.
Here is the United States Supreme Court June 19, 2017 Opinion in
BRISTOL-MYERS SQUIBB CO. v. SUPERIOR COURT OF CALIFORNIA, SAN FRANCISCO COUNTY, ET AL.
or shortened link below