Our Team
Robert Goodman, PhD (Biochemistry) and Ralph Fucetola JD provide Proposition 65, Safety and Cosmetic Dossier Services.
Ralph Fucetola JD has 40+ years’ experience in the natural products industry, having practiced law as “The Vitamin Lawyer” (from 1971 through 2006) and having held executive positions in several natural product and dietary supplement companies, including Life Services Supplements (featuring the Durk Pearson and Sandy Shaw product line) during the 1980s, and the TrimSpa® Companies in the early 2000’s. He is a Notary Public. He currently works as the Principal Consultant at The Vitamin Consultancy – www.VitaminConsultancy.com and holds directorships in Natural Solutions Health, LLC and Pure Harvest Extracts, LLC. He is President of the Institute for Health Research - www.InHeRe.org and a resident of Sussex County, NJ.
Dr. Goodman has a PhD in Biochemistry and over three decades' experience as a laboratory collaborator, teacher, scientist and consultant in the natural products industry. He has taught courses in chemistry and biology at local colleges and resides in the New York metro area. Dr. Goodman holds US patents, including one for a cosmetic-toiletry composition. Dr. Goodman completed a postdoctoral fellowship in Cancer Biology (Radiology Dept.) and has worked in R&D of medical devices.
Prop 65 New Rules
Started August 2018
Your business is in danger of heavy fines and legal costs (including the plaintiff's lawyer fees) if you sell products that Californians, "purchase, in their homes or workplaces, or that are released into the environment..."
Even if you do not sell directly in California! If your products come into contact with people in California-- whether you make it or sell it! Your company does not have to be a California company. You need to be prepared.
For instance, if you are selling dietary supplements that have any ingredients on the 900 item List (which for example, includes a form of Aloe) you need to know if the ingredient is above or below the "safe harbor" level.
It's no longer enough to post a general notice since the rule will now require a strong warning listing the specific ingredients on the List.
Our Services
SAFETY DOSSIERS
My Channel
POWERFUL SAFETY DOSSIER SERVICES
[1] Safety Data Sheets
[2] California Proposition 65 Dossier Services
[3] Cosmetic Safety Dossier Services
[4] Process Authority Letters
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CLICK FOR WHAT YOU NEED TO KNOW:
MoCRA Cosmetic Rules Started December 2023
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Safety Data Sheets for Online Selling
Amazon is Requiring Them
Professional and Quick!
CLICK FOR MORE
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For Companies Whose Products Are
Marketed or Used in California
Companies with products that are marketed or used in California are subject to the Proposition 65 Regulation that requires a warning on the label for certain "known" carcinogenic or reproductive harming chemicals. The cost of violating the law can be very high. Learn more here: PROP 65 FAQS & SERVICES.
The Services Include a Prop 65 Look-Up System (under development) and several levels of Dossier Reports:
[1] No Ingredients on the Prop 65 List Certification
[2] Safe Harbor Level Report for Ingredients on the List
[3] Safety Dossier for Other Listed Ingredients
[4] Process Authority Letters
USE OUR CONTACT FORM TO INQUIRE FOR SERVICES.
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For Natural Product & Cosmetic Companies
Introducing Cosmetic Products
to the Marketplace
[USA & EU Safety Regulations Are Similar]
Companies wishing to market cosmetics in the USA and/or European Union are required to maintain certain records in the Product Information File (Dossier).
This is required by US FDA Regulation Sect. 740.10 And EU Regulation Article 7.
The Safety Assessment Certification provided by third party consultants needs to meet the regulation requirements.
Our services are designed to meet these requirements.
This includes:
1.Consultation regarding the required “description of the qualitative and quantitative composition.”
2.Confirmation of the required “physic-chemical and microbiological specification” as certified by the responsible person at the Company; the Notarized Confirmation Document attests that our search of the scientific literature supports the specification as reported.
3. Consultation regarding description of the SOPs for method of manufacture complying with cGMPs.
4.Certified Assessment of Safety; this Certification Document shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure, and shall take particular account of the specific exposure characteristics of the areas on which the product will be applied or of the population for which it is intended.
5. Dossier Cover and Summary; your Company can rely on our work.
6. Process Authority Letters -- As needed in particular circumstances.
Click "More" for additional details.
Connect with Us
Professional Guidance for the Industry
TEL:
973.300.4594
eMAIL:
URLs:
www.ProfessionalSafetyDossier.com