Italian Sunshine Reporting for Nutraceutical Companies
Table of content
Author
May Khan leads the Compliance Services team at Vector Health, a SaaS company specializing in life sciences compliance. Her experience includes global transparency reporting, Sunshine Act strategy, and HCP risk monitoring. At Vector, she coordinates cross-functional teams dedicated to data integrity, customer service, and regulatory alignment.
Vector Health Compliance
Il principale partner in Italia per la conformità al Sunshine Act
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For years, nutraceutical companies operated in a regulatory gray zone, part food, part health, part consumer product. But with Legge 62/2022 (the Italian Sunshine Act) to be implemented soon, that gray zone is gone. Today, if your nutraceutical company interacts with dietitians, nutritionists, and healthcare organizations, your activities fall squarely under the same transparency obligations that apply to pharmaceutical and medical device manufacturers.
Many in the sector may still be surprised by this shift, especially because reporting for nutraceuticals is not a requirement in many countries worldwide, not even in the United States. But the Italian Sunshine Act has cast a wide net. It explicitly mentions that: “prodotti nutrizionali commercializzabili nell’ambito della salute umana” are included in the definition of “impresa produttrice.” In other words, if your company makes or markets nutraceutical products for human health, the Sunshine Act applies, no exceptions, no grace period, no industry carve-outs.
Why Nutraceutical Companies Are Included
The purpose of the Italian Sunshine Act is to ensure transparency across the entire ecosystem where health-related products are created, promoted, prescribed, recommended, or used. That includes nutraceutical products such as:
- Probiotics and prebiotics
- Vitamins and supplements
- Functional foods
- Weight-management formulas
- Products used or recommended by physicians, dietitians, pharmacists, or specialty clinics
If these products, and the commercial interactions behind them, play any role in the healthcare decision-making chain, they qualify.
For nutraceutical companies, this means an important mindset shift: you are no longer just competing in consumer wellness; you are regulated alongside traditional life-science manufacturers when it comes to transparency.
What Nutraceutical Companies Must Report
Under Article 3 of the Sunshine Act, nutraceutical companies must disclose any transfer of value provided to healthcare professionals (HCPs) or healthcare organizations (HCOs), including:
Reportable Transfers of Value
- Sponsorships of events, conferences, or training
- Honoraria paid to speakers or consultants
- Payments for research or clinical evaluations
- Travel, meals, accommodation
- Donations of goods, samples, or educational materials
- Support to scientific societies or patient associations
- Fees for advisory boards or expert committees
Reporting Thresholds
- To HCPs: ≥ €100 per transaction, or ≥ €1,000 annually
- To HCOs: ≥ €1,000 per transaction, or ≥ €2,500 annually
Once these thresholds are exceeded, your company must report detailed information, including the beneficiary’s identity, the nature and value of the benefit, the purpose, the date, and any intermediaries used.
When and How Reporting Happens
Nutraceutical companies must submit their disclosures electronically to the Sanità Trasparente portal — the Ministry of Health’s public registry.
- Transfers of value (Art. 3): every semester, with reporting due by the end of the following semester.
- Shareholding or IP-related income (Art. 4): annually by January 31.
Foreign nutraceutical manufacturers that operate in Italy are also included and the reporting may be done by their Italian representative.
All data is published publicly for five years and is searchable by anyone.
How Nutrition Professionals & Dietitians Interact with the Medical and Nutraceutical Industry — A Global View
Recent evidence highlights that interactions between nutrition professionals (dietitians, RDNs, nutritionists) and the food / nutraceutical / supplement industry are widespread, and often complex.
- A 2025 survey among 167 registered dietitians (RDs) in Quebec, Canada found that 35.5% had participated in at least one industry-sponsored scientific or professional event in the past year.
- Such events included conferences, symposiums, webinars, often involving major food or nutrition-related companies
- Beyond events, RDs reported other types of interactions: collaborating on research projects, providing nutrition consulting services to companies, helping develop nutritional content (e.g. nutrition tables, website content), supporting hospital food services, or liaising with industry sales representatives in clinical settings.
Nutrition professionals see some benefits in these interactions:
- 89.3% RDs in the survey agreed that collaborations could open career opportunities.
- 83–84% believed industry collaborations might improve the quality of food products or of nutrition information available to the public.
- Many RDs value industry-sponsored continuing education, which can be more accessible than academic or public-health funded events.
But there are also widely recognized risks:
- Blurring the line between independent professional advice and industry marketing / promotion, potentially undermining public trust in nutrition professionals.
- Risk of biased recommendations, where commercial interests may influence dietary advice, supplement recommendations, product positioning, or educational content.
- Concern that the “credibility of the profession” may be used to legitimize marketing messages, sometimes at the expense of stringent scientific or public-health standards.
Given this reality, numerous researchers recommend stronger policies, codes of ethics, and transparent disclosure mechanisms to manage, or limit, the influence of commercial actors on nutrition professionals.
What This Means for Italian Nutraceutical Companies
Given the growing and documented interactions between dietitians/nutrition professionals and industry globally, the transparency obligations under the Italian Sunshine Act become especially relevant:
- When nutraceutical companies engage dietitians, nutritionists, or other nutrition professionals as consultants, speakers, researchers, or advisors, that constitutes a “transfer of value” or “support”, and must be reported if thresholds are met.
- Sponsoring nutrition-related conferences, webinars or educational events, or supplying samples, supplements, educational materials, or other benefits to nutrition professionals / organizations should be disclosed.
- Collaborations on research, product development, or content creation involving nutraceutical firms and dietitians must be transparently reported.
- This transparency isn’t just a regulatory formality, it helps safeguard the credibility of both the nutrition profession and your company, aligning with best practices globally and reducing reputational risk.
In a market increasingly attentive to ethics, conflicts of interest, and evidence-based nutrition, transparent disclosure under the Italian Sunshine Act can become a competitive differentiator, signaling that your company respects professional independence and supports ethical partnerships.
Final Thoughts
The global data paints a clear picture: nutrition professionals regularly engage with the food, supplement, and nutraceutical industry. For nutraceutical companies operating under the Italian Sunshine Act, this reality makes transparency non-negotiable.
Compliance isn’t just about avoiding fines, it’s about building trust, preserving the integrity of the nutrition profession, and ensuring that collaborations lead to genuine improvements in public health, not just marketing gains.
Table of content
- Why Nutraceutical Companies Are Included
- What Nutraceutical Companies Must Report
- When and How Reporting Happens
- How Nutrition Professionals & Dietitians Interact with the Medical and Nutraceutical Industry — A Global View
- What This Means for Italian Nutraceutical Companies
- Final Thoughts
For years, nutraceutical companies operated in a regulatory gray zone, part food, part health, part consumer product. But with Legge 62/2022 (the Italian Sunshine Act) to be implemented soon, that gray zone is gone. Today, if your nutraceutical company interacts with dietitians, nutritionists, and healthcare organizations, your activities fall squarely under the same transparency obligations that apply to pharmaceutical and medical device manufacturers.
Many in the sector may still be surprised by this shift, especially because reporting for nutraceuticals is not a requirement in many countries worldwide, not even in the United States. But the Italian Sunshine Act has cast a wide net. It explicitly mentions that: “prodotti nutrizionali commercializzabili nell’ambito della salute umana” are included in the definition of “impresa produttrice.” In other words, if your company makes or markets nutraceutical products for human health, the Sunshine Act applies, no exceptions, no grace period, no industry carve-outs.
Why Nutraceutical Companies Are Included
The purpose of the Italian Sunshine Act is to ensure transparency across the entire ecosystem where health-related products are created, promoted, prescribed, recommended, or used. That includes nutraceutical products such as:
- Probiotics and prebiotics
- Vitamins and supplements
- Functional foods
- Weight-management formulas
- Products used or recommended by physicians, dietitians, pharmacists, or specialty clinics
If these products, and the commercial interactions behind them, play any role in the healthcare decision-making chain, they qualify.
For nutraceutical companies, this means an important mindset shift: you are no longer just competing in consumer wellness; you are regulated alongside traditional life-science manufacturers when it comes to transparency.
What Nutraceutical Companies Must Report
Under Article 3 of the Sunshine Act, nutraceutical companies must disclose any transfer of value provided to healthcare professionals (HCPs) or healthcare organizations (HCOs), including:
Reportable Transfers of Value
- Sponsorships of events, conferences, or training
- Honoraria paid to speakers or consultants
- Payments for research or clinical evaluations
- Travel, meals, accommodation
- Donations of goods, samples, or educational materials
- Support to scientific societies or patient associations
- Fees for advisory boards or expert committees
Reporting Thresholds
- To HCPs: ≥ €100 per transaction, or ≥ €1,000 annually
- To HCOs: ≥ €1,000 per transaction, or ≥ €2,500 annually
Once these thresholds are exceeded, your company must report detailed information, including the beneficiary’s identity, the nature and value of the benefit, the purpose, the date, and any intermediaries used.
When and How Reporting Happens
Nutraceutical companies must submit their disclosures electronically to the Sanità Trasparente portal — the Ministry of Health’s public registry.
- Transfers of value (Art. 3): every semester, with reporting due by the end of the following semester.
- Shareholding or IP-related income (Art. 4): annually by January 31.
Foreign nutraceutical manufacturers that operate in Italy are also included and the reporting may be done by their Italian representative.
All data is published publicly for five years and is searchable by anyone.
How Nutrition Professionals & Dietitians Interact with the Medical and Nutraceutical Industry — A Global View
Recent evidence highlights that interactions between nutrition professionals (dietitians, RDNs, nutritionists) and the food / nutraceutical / supplement industry are widespread, and often complex.
- A 2025 survey among 167 registered dietitians (RDs) in Quebec, Canada found that 35.5% had participated in at least one industry-sponsored scientific or professional event in the past year.
- Such events included conferences, symposiums, webinars, often involving major food or nutrition-related companies
- Beyond events, RDs reported other types of interactions: collaborating on research projects, providing nutrition consulting services to companies, helping develop nutritional content (e.g. nutrition tables, website content), supporting hospital food services, or liaising with industry sales representatives in clinical settings.
Nutrition professionals see some benefits in these interactions:
- 89.3% RDs in the survey agreed that collaborations could open career opportunities.
- 83–84% believed industry collaborations might improve the quality of food products or of nutrition information available to the public.
- Many RDs value industry-sponsored continuing education, which can be more accessible than academic or public-health funded events.
But there are also widely recognized risks:
- Blurring the line between independent professional advice and industry marketing / promotion, potentially undermining public trust in nutrition professionals.
- Risk of biased recommendations, where commercial interests may influence dietary advice, supplement recommendations, product positioning, or educational content.
- Concern that the “credibility of the profession” may be used to legitimize marketing messages, sometimes at the expense of stringent scientific or public-health standards.
Given this reality, numerous researchers recommend stronger policies, codes of ethics, and transparent disclosure mechanisms to manage, or limit, the influence of commercial actors on nutrition professionals.
What This Means for Italian Nutraceutical Companies
Given the growing and documented interactions between dietitians/nutrition professionals and industry globally, the transparency obligations under the Italian Sunshine Act become especially relevant:
- When nutraceutical companies engage dietitians, nutritionists, or other nutrition professionals as consultants, speakers, researchers, or advisors, that constitutes a “transfer of value” or “support”, and must be reported if thresholds are met.
- Sponsoring nutrition-related conferences, webinars or educational events, or supplying samples, supplements, educational materials, or other benefits to nutrition professionals / organizations should be disclosed.
- Collaborations on research, product development, or content creation involving nutraceutical firms and dietitians must be transparently reported.
- This transparency isn’t just a regulatory formality, it helps safeguard the credibility of both the nutrition profession and your company, aligning with best practices globally and reducing reputational risk.
In a market increasingly attentive to ethics, conflicts of interest, and evidence-based nutrition, transparent disclosure under the Italian Sunshine Act can become a competitive differentiator, signaling that your company respects professional independence and supports ethical partnerships.
Final Thoughts
The global data paints a clear picture: nutrition professionals regularly engage with the food, supplement, and nutraceutical industry. For nutraceutical companies operating under the Italian Sunshine Act, this reality makes transparency non-negotiable.
Compliance isn’t just about avoiding fines, it’s about building trust, preserving the integrity of the nutrition profession, and ensuring that collaborations lead to genuine improvements in public health, not just marketing gains.
Author
May Khan leads the Compliance Services team at Vector Health, a SaaS company specializing in life sciences compliance. Her experience includes global transparency reporting, Sunshine Act strategy, and HCP risk monitoring. At Vector, she coordinates cross-functional teams dedicated to data integrity, customer service, and regulatory alignment.
Vector Health Compliance
Il principale partner in Italia per la conformità al Sunshine Act
Cerchi supporto per la compliance al Sunshine Act?
Hai domande pratiche?
Dai un’occhiata alla nostra sezione Domande Frequenti per risposte chiare su scadenze, obblighi e strategie.