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
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
Commercial Marketing notice prior to obtaining a license. Here is the link to the official U. S. Supreme Court opinion https://www.supremecourt.gov/opinions/16pdf/15-1039_1b8e.pdf
Held: An applicant may provide notice of commercial marketing before obtaining a license/approval from FDA.
The Biologics Price Competition and Innovation Act of 2009 (BPCIA or Act) provides an abbreviated pathway for obtaining Food and Drug Administration (FDA) approval of a drug that is biosimilar to a licensed biological product known as the reference product.
Section 262(l)(8)(A) of the (BPCIA or Act) states that the applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the bio-logical product licensed under subsection (k).” See 42 U. S. C. §262(k).
What does FDA say? Recently FDA published a final rule about the following- “Intended Use”-Products Made from Tobacco. Is my product a Drug, Device and/or Both? Here is the rule summary and link. Check back soon for an update. http://bit.ly/2lxvPiO
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 801, and 1100 [Docket No. FDA–2015–N–2002]
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
Check back soon for an update. http://bit.ly/2lxvPiO