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Wednesday, June 5, 2024
Friday, May 17, 2024
Comparing IRS Exempt Status Provisions
One of the Amish groups with which I consult is creating a 'half way house' to help fallen-away Plain People re-integrate into the Plain Community. I answered their question regarding exempt status this way:
You asked me to explain the differences among entities under sections 501(a) [Title Holding Company], 501(c)(3) [nonprofit exemption] and 508 [Mandatory Exemption for churches, associations of churches and church auxiliaries].
[1] Section 501 provides that any entity which is formed to hold property for an exempt organization, and which pays all of its net profits to the exempt organization, is exempt to the extent it is not debt financed. This type of entity is usually formed to hold and operate potentially profitable property, with all profits to the exempt parent organization.
[2] Section 501(c)(3) is the standard provisions covering nonprofits and religious organizations which are organized and operated exclusively for religious, charitable, educational etc., purposes. These organizations are exempt upon approval by the IRS, after submitting the required forms and paying the required fees to the IRS (about $500).
[3] Section 508 says that churches, church associations and church auxiliaries [which is what I think your organization is] are "mandatorily exempt." This has been interpreted to mean that such an organization does not have to apply for the exemption, but if they do, it should be granted.
I'd like to remind you that a religious organization is not a nonprofit. It is exempt. I do not recommend forming a nonprofit corporation except to hold property separate from the organization.
Wednesday, October 18, 2023
Congress Sneaks Another Bone to Big Pharma!
New Peptide Rules
Congress subtly changed the definition of a 'biological product' to give Big Pharma control of the sale of proteins to treat disease. As usual such maneuvers leave loopholes within the loopholes...
"The FDA had previously stated its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide” in the amended statutory definition of “biological product.” The FDA interprets the term “protein” to mean any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size. Alternatively, the FDA previously interpreted the term “chemically synthesized polypeptide” to mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids, but less than 100 amino acids in size.
A “chemically synthesized polypeptide” was not a “biological product” and was not going to be regulated as a drug under the FD&C Act unless the polypeptide otherwise met the statutory definition of a “biological product.” This definition was scientifically appropriate, but at the last minute, the latest appropriations bill (enacted in December of 2019) further amended the definition of “biological product” to remove “(except any chemically synthesized polypeptide).” Now, in the definition ... there is no differentiation between protein and polypeptide." [1]
The new definition is:
"Biological Product – A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings." [2]
Note that the parenthetical “(except any chemically synthesized polypeptide)” has been removed.
FDA further states:
"Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated." [3]
Under the new definition, as interpreted by FDA, any "protein" 40 or less amino acids is still available as a "food" product. Any naturally occurring protein that is not chemically changed appears to still qualify as a food and thus as a Medical Food. Doctors may recommend Medical Foods for the dietary management of health conditions.
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[1] https://bengreenfieldlife.com/article/supplements-articles/peptides-fda/
[2] "This final rule codifies the Food and Drug Administration’s (FDA or Agency) interpretation of the statutory term “protein” that the Agency previously described in guidance (Ref. 1). This final rule does not finalize the FDA’s interpretation of “chemically synthesized polypeptide” because section 605 of the Further Consolidated Appropriations Act, 2020 (Public Law 116-94) (FCA Act) removed the parenthetical “(except any chemically synthesized polypeptide)” from the category of “protein” in the definition of “biological product” in section 351(i) of the Public Health Service Act (PHS Act). F" -- https://www.fda.gov/media/135421/download
[3] https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product
Friday, October 6, 2023
MoCRA: Modernization of Cosmetics Regulation Act of 2022
MoCRA: Modernization of Cosmetics Regulation Act of 2022
Last year Congress adopted the first comprehensive amendment to the cosmetic laws since 1938. The Modernization of Cosmetics Regulation Act of 2022 — MoCRA — empowers FDA by making mandatory various previously ‘voluntary’ requirements for cosmetics sold to Americans. In summary:
Mandatory facility and product registration
Adherence to cosmetics Good Manufacturing Practices (GMPs)
Adverse event reporting
Safety substantiation
Additional labeling requirements
New enforcement powers and records access for FDA
The new law goes into effect on December 29, 2023. FDA expects to have an online registration system by then. I will be working closely with my clients to make sure their cosmetic products meet the new standards.
Once MoCRA takes effect registration will no longer be voluntary but will be required for every cosmetics manufacturing facility, regardless of where it is located.
FDA defines cosmetics at “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)”
“…by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. “ https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic
Email me at ralph.fucetola@gmail.com with “Cosmetics” in the subject line to get started. Each of your cosmetic products must be registered. This is immediately important for all cosmetic-label-owners and for manufacturing facilities that handle cosmetics.
See also: www.ProfessionalSafetyDossier.com
Additional Notes:
1. All cosmetic products will have to register with FDA, providing:
Place of manufacture
Product category
Ingredients (fragrances, flavors & colors)
FDA will assign a product listing number.
2. FDA will propose a Good Manufacturing Practices rule within 2 years.
3. Adverse Event Reporting, defining AER:
“death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, significant disfigurement (serious or persistent rashes, second or third degree burns, hair loss, or persistent or significant alteration of appearance), or an event which requires medical intervention to prevent the health outcomes listed above.”
4. FDA web page about MoCRA: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022
5. FDA Cosmetic GMP Guidance: https://www.fda.gov/media/86366/download?attachment
6. FDA MoCRA site: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products
7. Small Business Exemptions: https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-compliance-policy-cosmetic-product-facility-registration-and-cosmetic-product-listing
Exemptions:
MoCRA exempts certain small businesses from facility registration and product listing requirements.
However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:
- Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
- Products that are injected.
- Products that are intended for internal use.
- Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
Thursday, July 6, 2023
Private Business Plan
SYMPHONY CANNA
BRANDS, LLC
A New Jersey Company
Licensed Cannabis
Cultivation
& Manufacturing Business Plan
FUNDING: $5,000,000
Disclaimers and Disclosures:
This Business Plan contains proprietary information about Symphony Canna Brands and may not be reproduced, copied, disclosed, or utilized in any way in whole or in part, without the prior written consent of Symphony Canna Brands.
This is a business plan. It does not imply an offering of securities. These estimates are based on our experience, together with our good faith estimates for the development of the business based upon due diligence research and communication with wholesalers.
This memorandum contains forward-looking statements that are based on management's expectations, estimates, projections and assumptions. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results may vary.
Ó 2023
Jonathan (Avi),
Wertenteil – Chief Executive Officer
Bruce Cooper –Chief
Operating Officer
Ralph, Fucetola JD –
Chief Compliance Officer
Location, Facility, and Production
Overview for Phase One
Resolution from City of
Bridgeton
Letter of Support from
City of Bridgeton
Approval for Cultivation
License
Approval for
Manufacturing License
New Jersey Annual Cultivation & MANUFACTURING LICENSE
Business Plan
Having legalized medicinal cannabis for use by registered patients following legislative action in 2010, New Jersey is an older cannabis market that saw the program’s implementation stall at its initial rollout and in later licensing rounds. Since 2018, the state has witnessed exponential growth in medicinal cannabis patient count and total sales, with total spending for 2019 surpassing $107 million.[1] In 2021 the state opened its doors to the newly formed recreational market. Our team received Minimality approval and submitted a full cultivation and manufacturing application to Cannabis Regulatory Commission (CRC) in December 2021.
We aim to enter the market at the onset of adult-use legalization, which is expected to generate over $1 billion in annual sales by 2024.[2] Our business has thoroughly planned and prepared for the challenges inherent in operating a cannabis cultivation business, and we are thrilled to present this opportunity.
Symphony Canna Brands, LLC (Symphony Canna Brands) is a New Jersey business founded by Jonathan (Avi) Wertenteil, Ralph Fucetola and Bruce L. Cooper for the purpose of starting low-cost cannabis cultivation and manufacturing in New Jersey. With a team of seasoned cannabis experts, we plan to cultivate approximately 150,000 square feet of canopy area, along with a 10,000 Square feet processing, packaging, manufacturing, and distribution area. Our plan is to utilize both the cultivation license and manufacturing licenses to produce and distribute packaged products directly to retailers and delivery services thought the state.
Symphony Canna Brands LLC was created to capitalize on the new and growing opportunity presented by the adult-use cannabis legalization and upcoming licensing round in New Jersey. Our goal is to secure a significant market share of the target state of New Jersey with high-quality cannabis products. Symphony Canna Brands was awarded both cultivation and manufacturing licenses in June 2023. Due to these factors, Symphony Canna Brands is well positioned and well equipped to seize the opportunity presented in the New Jersey adult use cannabis Market. Due to our existing relationships, retailers around the state are ready to accept products from our production facility.
Our vision is to cultivate, manufacture and distribute the best cannabis products to retailers and delivery services thought the state while maintaining low costs. During our discussions with the local municipality, we floated the idea of hiring inmates from the state prison near our facility and have received positive feedback from the municipality (see letter of support from Bridgeton) We also have an agreement to provide on-the-job training for qualified former inmates from the Nehemiah Group (Local Halfway House). Although there is a well-known cycle of individuals with a criminal history that, when released from prison, experience challenges reintegrating into society and often return to similar habits that lead to future incarceration, we have decided to work with former inmates. On-the-job training reminds inmates that they do have value in society and inspires them to pursue a life that does not require them to break laws. Furthermore, there are other nearby businesses in the industrial zone where our property is located that utilize cheap labor by hiring inmates in their facilities.
Our growers and operators have decades of experience in the medicinal cannabis sector, and they will utilize their knowledge and expertise to assist Symphony Canna Brands in all aspects of its business. Our growers and operators have worked on large scale cannabis projects in both indoor and outdoor settings. We believe this is a unique advantage that Symphony Canna Brands will have. Symphony Canna Brands will produce high quality cannabis products and will enhance the cannabis ecosystem that New Jersey is nurturing to a profitable, statewide industry.
Our Mission is to provide superior quality cannabis products for the New Jersey recreational cannabis market. We intend to cultivate with only organic ingredients and plan on using low-cost production methods without compromising the quality of the cannabis.
Symphony Canna Brands has assembled a team of business leaders and industry executives with ample experience and expertise to lead Symphony Canna Brands to profitability in almost any scenario. Our business is led by Jonathan (Avi) Wertenteil, Chief Executive Officer, Bruce Cooper, Chief Operating Officer, and Ralph Fucetola, Chief Compliance Officer. Combining Bruce’s leadership capabilities with Avi’s cannabis cultivation entrepreneurial background and Ralph’s decades of legal experience, there is a strong leadership foundation. In addition, Ralph’s three and a half decades of pharmaceutical compliance experience will prove to be crucial in this very highly regulated industry. Together, our leadership brings the experience and skills required to be profitable in the cannabis space. The following is a detailed description of everyone’s experience and skillset.
Jonathan (Avi), Wertenteil – Chief Executive Officer
Avi brings substantial experience in the cannabis industry as the founder of Red Hill Organics, a leading cannabis cultivation company in California that cultivated over 88,000 square feet of canopy grow space supplying licensed dispensaries throughout California. Avi received a bachelor’s degree in business administration and is proficient in navigating regulatory compliance and worked closely with the California department of food and agriculture to ensure that all local and state regulations were satisfied. Additionally, Avi served in an elite paratrooper’s unit in the Israeli Defense Force for three years.
Bruce Cooper – Chief Operating Officer
Bruce brings over 20 years of varied, in-depth experience as a senior police officer in the New Jersey State Human Service Police as well as a caseworker for the Camden County Board of Social Services. Bruce received a bachelor’s degree in Management Science from Kean University and served as a U.S. Navy Third Class Petty Officer on the USS Belknap CG-26. Inspired to serve his community, Bruce was elected as both the Millville City Commissioner and a Member of the School Board and is a John Maxwell-Certified Life Coach, Speaker, and Trainer. Collectively, Bruce’s roles in the highly regulated industries of law enforcement, social services, and the Navy have provided him with a knowledgeable, informed perspective, which translates to a multitude of relevant, transferable skills such as leadership, organization, project management, critical thinking, government regulations, public safety and security, and problem solving. Bruce is equipped with the requisite business acumen to apply his knowledge, skills, and experience to the highly regulated cannabis industry.
Ralph, Fucetola JD – Chief Compliance Officer
Ralph is a preeminent leader in several highly regulated industries including nutrients, vitamins, alternative health, and cannabis. Ralph is known by the moniker of the “Vitamin Lawyer,” given his status as a renowned author and educator, with dozens of his articles published in numerous journals and websites. Ralph received a bachelor’s degree with Distinction and a Juris Doctor from Rutgers University. He operates a consulting practice specializing in systems process integration claims; advertising and label review; consulting with marketers, consumers, advocates, and local attorneys regarding regulatory issues and petitions and litigation. Ralph carefully applies the business acumen, knowledge, experience, and skills from his roles in the nutrients, alternative health, and vitamins industries to provide a competitive edge as an advisor to the management and application teams for the New Jersey medical and adult use cannabis licenses. Ralph’s knowledge, skills, and experience provide a well-rounded perspective of many of the central issues, variables, and facets affecting the cannabis industry.
Business development is the heart of any successful cannabis production, and we intend to implement detailed strategies to facilitate development, including building a strong presence in the market, achieving, and maintaining a positive cash flow, implementing a scalable marketing strategy, and sustaining business growth over time. Achieving market validation and building an initial distribution and customer base will be the foundation of the business, from which we will expand to reach more and more customers. The first challenge for our company will be to attract an initial pool of customers, who will then spread the word about our brand as a result of our extraordinary product quality and selection. We will also engage in substantial marketing and advertising to the extent allowed by law, helping to further develop our presence in the market and alert more licensed cannabis businesses, especially distribution and dispensary businesses, to the existence of our new cannabis cultivation facility. Additionally, as one of only a handful of licensed cannabis businesses in New Jersey, we will essentially have a captive market, as the state’s large customer base will be forced to choose from only a small number of providers with whom they may lawfully do business. As the business and its customer base expands, we will quickly achieve positive cash flow, rapidly growing sales sufficient to generate a return on investment. Finally, the business will sustain this growth by staying on the frontlines of advancements in the industry, hiring and training quality employees, skilled managers, and executives, and adapting to changes in the swiftly developing market.
Location, Facility,
and Production Overview for Phase One
The location of the facility is on a 4.5-acre property in an industrial zoned park in the city of Bridgeton in Cumberland County, New Jersey. The property has an existing 13,000 square foot building that was constructed three years ago and is in excellent condition. The address is 5 South Industrial Drive, Bridgeton, New Jersey.
In Phase One, our facility will have 4 indoor grow rooms that total 3,000 square feet of indoor flowering canopy. Each room will be harvested three times a year enabling us to stagger our harvests monthly ensuring a constant supply. Additionally, we intend to build a 10,000 square feet state of the art high tech greenhouses for low-cost year-round production of low-cost cannabis flower.
In order to satisfy the demand for water, we plan to install five 10,000-gallon water tanks. We will drill one or more environmentally friendly wells on our property, as necessary, in order to eliminate the use of municipal water. Instead of wasteful reverse osmosis water cleaning systems, we will use high-powered filters that will achieve optimal results for our purposes without producing excess wastewater. We plan to use automated watering and fertigation systems such as Roots Talk and Dosatron that will allow our facility to function more sustainably and predictably. We plan on installing environmentally friendly LED lights such as Gavita.
Our indoor grow rooms will use a hydroponic system along with a CO2 delivery system that will push air under the plants, increasing air flow and decreasing stagnation that can foster contaminants. We intend to follow standard industry practices and utilize dehumidifiers, carbon filters, HVAC, and integrated controls to monitor the grow room environment and mitigate odors.
Along with the 13,000 square foot cultivation canopy we plan
to build a state-of-the-art nursery to grow baby plants that can be transferred
to the flowering cultivation area. Additionally, we intend to build an
approximately 9,000 square foot manufacturing, processing, packaging, storage,
and distribution center where we will create specialty products such as
pre-rolls, infused pre-rolls, vapes, oils, topicals, infused foods, infused
drinks. All products will be packaged under our variety of in-house brands
which then be sold and distributed to retail outlets across the state.
Site Map of 5 South Industrial Drive
Bridgeton NJ
With proceeds from the operating business our team intends
on utilizing all 150,000 square feet of licensed cultivation canopy. An
additional 50,000 square feet of high-tech greenhouses will be installed on the
existing property. Additionally, we will expand to the property that we
acquired with initial startup funds in order to build 87,000 of outdoor
cultivation canopy, which be utilized for the creation of low-cost biomass for
specialty vape concentrates carts that will be sold by the gram. Below is an aerial image of 6 South
Industrial Drive where we intend to house the expansion.
The US cannabis industry grew by more than 23% in 2020, most of which was in adult-use markets. In the past few years, the population of New Jersey has experienced rapid growth. We will capitalize on both of these points by obtaining a cultivation license at the onset of adult-use legalization, which is expected to generate over $1 billion in annual revenue. The 2017 National Survey on Drug Use and Health, commissioned by a branch of the US Department of Health and Human Services, found that 2.5% of adult respondents were daily or almost daily cannabis users, nearly 8% had used cannabis within the past month, and 15% had used cannabis within the past year.
Assuming these national figures hold true at the state level, New Jersey contains nearly 250 thousand daily cannabis users, 769 thousand additional monthly users, and over 1.3 million annual users (not inclusive of monthly and daily users). From the analysis of survey data on the consumption habits of cannabis users, the most recent studies indicate heavy non-medical users consume an average of 1.3-1.9 grams per day of cannabis flower. Our market analysis assumes a convergence to a daily consumption rate significantly below this range in establishing an eventual market size estimate.
As the number of cannabis users in the population increases, the number of infrequent consumers will increase, which will lower the average demand per adult cannabis consumer. An examination of Colorado’s relatively mature adult-use statistics for baseline market measurements is enlightening. In 2017, with a population of 5,700,000, Colorado realized sales of 55,437 pounds of cannabis per month. This translates to a per capita consumption level of 1.867 ounces per year, or 0.156 ounces per month. In order to be conservative, we have estimated New Jersey's consumption levels to be half of this rate, i.e., t0.0778 ounces per capita per month (less than one tenth of one gram per day). As the market matures, we assume that per capita demand per month will increase significantly. This implies a monthly statewide demand of 777,689 ounces by the end of the first year of the program.
With the initial licensing of only 37 cultivation centers, we expect to produce at least 21,000 ounces of cannabis annually to meet state needs. Even while building in conservative practices at multiple levels of our market analysis, these estimates suggest an extremely healthy market outlook for our proposed cultivation business. We believe that the demand for adult-use cannabis in New Jersey will support a competitive market for many years to come. Many adult-use states like Colorado and California rely heavily on national and international tourism to provide a consistent source of revenue. Additionally, our state welcomes an average of 100 million tourist annually, according to the New Jersey Economist Division.
Company Documents:
Resolution from City of Bridgeton
Letter of Support from City of Bridgeton
Approval for Cultivation License
Approval for Manufacturing License
