5 JUNE 2024 NEWSLETTER

Summer Time is Time to… Audit GMP Compliance To Prepare for Fall & Holiday Sales Campaigns Walk Me (Virtually) Through Your Facility My Red Flag Virtual Audit Covers Your Highest Risks! Special Hourly Rate for Virtual Audits:  $200 Email me at ralph.fucetola@gmail.com - Subject: Audit

Review GMP Documents and Records Review GMP Personnel, Training & Hygiene Review GMP Physical Plant and Grounds Review GMP Equipment, Utensils & Instrumentation Review GMP Quality Control and Quality Assurance Review GMP Components, Packaging and Labeling Review GMP Lot Control, Tracking and Traceability Review GMP Master Manufacturing and Batch Production Records Review GMP Specifications, Testing and Finished Product Release Review GMP Laboratory Operations Review GMP Investigations, Non-Conforming Products and CPA (Corrective and Preventative Actions) Review GMP Holding and Distribution Review GMP Product Complaints Report GMP Close-Out, Report and Follow-up

PRACTICE NOTE:   Amazon's updated dietary supplement policy for 2024 has introduced significant changes for sellers in the following categories: Sexual Enhancement, Weight Management, and Bodybuilding & Sports Nutrition. The policy now requires Certificates of Analysis (COAs) to be submitted through an approved third-party Testing, Inspection, and Certification (TIC) company to ensure enhanced chain of custody and product authenticity. Key testing requirements include: Heavy metals Microbial contaminants Pesticides & THC (if applicable) In addition to these tests, Seller Partners must also have a COA for: Content claims verification Active pharmaceutical ingredient screen (based on the risk category)

YOU CAN SUPPORT DR. RIMA’S ORGANIC COFFEE PHYTONUTRIENT PROJECT HERE: https://fundly.com/vitality-brew

MoCRA: Modernization of Cosmetics Regulation Act of 2022 Deadlines

SOPs Consistent with MoCRA Now Available at discount! Email ralph.fucetola@gmail.com with "MoCRA SOPs" in Subject Line Yes, you must have SOPs for your Cosmetic Products… 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

The Super Patch Opportunity

You know Opportunity Knocks… but you have to answer.   Dr. Rima is recommending the Super Patch, a unique method for communicating what your brain needs to achieve and maintain homeostasis.  This is not a nutrient patch. Rather, it is a data patch, set with unique patterns that act as biofeedback triggers. And better yet, the Super Patch is a multilevel program that you can leverage to your customer base, building residual income.  It’s up to you. Here is Dr. Rima on the Super Patch: http://www.opensourcetruth.com/speaking-to-your-self/ — the link to our Super Patch site is there. “One of the great mysteries of science is how we know what we know, mentally, spiritually, emotionally, intuitively and physically.  If I write a number “8” on your skin when your eyes are closed, how does your brain figure out what it is? If I touch you kindly, how do you know my intention if you do not see or hear me? How do we feel pain and what determines how we respond to it? How do we differentiate between pain and pleasure and how do we know that we know anything at all? . . . They showed, for example, that known and verified markers of wellbeing and longevity like mobility, flexibility and balance could improve dramatically when people used their Liberty Super Patch. And the results can be immediate, as indicated by research MRI scans.  They showed that athletic performance in every one of the many areas studied often increased by around 18% after this technology was placed in contact with the skin. The patches appear to act as a type of biofeedback, communicating with the brain.” Read more here:   http://www.opensourcetruth.com/speaking-to-your-self/ Opportunity knocks… give me a call:  732.619.1568

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.