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 Finally in late 2017, FDA issued a draft guidance entitled Drug Products Labeled as Homeopathic.” 

The draft guidance explains how FDA expects to prioritize enforcement and regulatory action with respect to drug and biological products, labeled as homeopathic and marketed in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






Prison Sentences- Peanut Corp.of America Salmonella Tainted Peanut Products

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


All Matters FDA Conference

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.

Death Wish Coffee Co. Announces Recall of Nitro Cold Brew Cans From Retailers, Online Sales

Company Recall of Nitro Cold Brew

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.”

$57.1 Million Verdict Pelvic Mesh Implants Against J&J’s Ethicon, Inc.

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

Pink Slime – Beef Products Inc. v. ABC Defamation Lawsuit Settled Mid-trial

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.

Biosimilars Sandoz Inc. v. Amgen Inc.

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).

Final Rule Issued: Intended Use ….. Far From the Final Word.

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.  bit.ly/2lxvPiO


Food and Drug Administration

21 CFR Parts 201, 801, and 1100 [Docket No. FDA–2015–N–2002]
RIN 0910–AH19

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.  bit.ly/2lxvPiO