Sunday, October 29, 2017

California Increases Prop 65 Regulation Controls

Proposition 65: Carcinogenic Chemicals Notification
California Increases Regulation Controls

In 1986 California voters adopted Proposition 65,

“That initiative became the Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65. Proposition 65 requires the State to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm. This list, which must be updated at least once a year, has grown to include approximately 800 chemicals since it was first published in 1987. Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase, in their homes or workplaces, or that are released into the environment.”

Since California is a major part of the US economy, as a practical matter, all businesses selling across state lines find that they must conform to the California law, or provide special California labeling for products shipped to sold in California.

The List of chemicals is here;
There are certain limits on the disclosure rule.

“Businesses with less than 10 employees and government agencies are exempt from Proposition 65’s warning requirements ... Businesses are also exempt from the warning requirement …  if the exposures they cause are so low as to create no significant risk of cancer or birth defects or other reproductive harm...”

“No significant risk” means less than one chance in a 100,000 of causing cancer, or one in 1,000 of causing reproductive harm.

The California government has published “safe harbor” numbers for some substances on the List to guide businesses in determining their responsibilities, here:

The question businesses must consider is whether any chemical in the product is in “significant amounts” and must therefore be disclosed by a Notice on the label or if the “exposures” are so low as to “create no significant risk...” and thus no duty to warn.

If the ingredient is one of the named ingredients on the label and it is on the List then, clearly, the Notice is required.

If the substance is a named ingredient, but is only incidentally present, or is used only in process, the question remains: is there a significant amount to disclose?

California reminds businesses:

“Although a business has the burden of proving a warning is not required, a business is discouraged from providing a warning that is not necessary and instead should consider consulting a qualified professional if it believes an exposure to a listed chemical may not require a Proposition 65 warning.”

When a Warning is required, it must be “clear and reasonable”

In January 2017 California changed the safe harbor rules for when a Warning is “clear and reasonable.

One online source reported:

“The new regulations now require that the safe-harbor warning include the word “WARNING” in all capital letters and bold print and further require that a symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline precede the warning.  The new regulations further specify different safe-harbor warnings for products that contain only carcinogens, only reproductive toxicants, both listed carcinogens and listed reproductive toxicants, or a listed chemical that is both a carcinogen and reproductive toxicant.”

Here is how a compliant warning will look when the new regs are fully enforced:

Happily there is a simpler “on bottle” warning that can be used at least for the time being.

In addition to the on the label Warning, the new regs address online warnings:

“To comply with the safe-harbor provisions for Internet purchases, the new regulations require companies to include the safe-harbor warnings on the product display page, in a hyperlink using the word “WARNING” on the product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase.”

In summary, the new regs will direct consumers to a special P65 government web page. It will be important to make sure that required link opens in a new tab, so the potential customer will not lose the purchase page while looking at the Warning.

Further, going forward, when you give the required Warning, you must also name the chemical(s) for which the warning is given. You will need accurate tests and a clear Proposition 65 Plan.

The new regulations are fully effective on August 30, 2018 for any product manufactured after that date.

The sooner companies get ready, the better! The Vitamin Consultancy will offer Proposition 65 “No Significant Risk” Dossiers, similar to our Cosmetic Safety Dossier – – to enable compliance with the law, by either complying with the Warning requirement or by having the assurance that the substances pose no significant risk.

The Vitamin Consultancy Archives are here:
The Vitamin Health Freedom Blog is here:

Saturday, September 9, 2017

Intentional Adulteration Defense

Intentional Adulteration Defense
Online Free Trade Certificate

Newsletter of 09 September 2017

Guidance for Industry
Mitigation Strategies to Protect Food
Against Intentional Adulteration -
What You Need to Know About the FDA Regulation:
Small Entity Compliance Guide

Congress adopted the Food Safety [sic] Modernization Act (FSMA) in 2010 (I was involved in the successful effort to protect DSHEA from some of the provisions of the act). Among other steps, the Act directed the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to, as FDA states, "better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation."

On May 27, 2016, FDA published a final rule, Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule) (81 FR 34165), that, the Agency states, "creates new requirements for the production of food by registered food facilities to protect the food supply against intentional adulteration. "

Posted on August 24, 2017 FDA issued a Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). FDA says, "This guidance document is intended to assist small entities in complying with the rule set forth in 21 CFR 121 concerning Mitigation Strategies to Protect Food Against Intentional Adulteration. The rule is binding and has the full force and effect of law."

The good news is that the Guide gives companies several years to comply with the more stringent regulations.

You can read the entire Guide here: or you can subscribe to the Vitamin Consultancy's OPS -- Operating Procedures System, to be assured of haveing the tools you need to be in compliance.

Here is what the FDA says is the Primary Requirement:

"The rule requires a written food defense plan for all covered facilities ... (21 CFR 121.5). The written plan must include (21 CFR 121.126):

    • A vulnerability assessment to identify -
        significant vulnerabilities and
        actionableprocess steps,
        and associated explanations
    • Mitigation strategies and associated explanations
    • Procedures for food defense monitoring
    • Procedures for food defense corrective actions
    • Procedures for food defense verification"

Therefore, primarily, you will need to adopt and implement an Intentional Adulteration Avoidance SOP that meets the Primary Requirement and others set out in the Guide. Drafted by the Vitamin Consultancy's experts, you can rest assured that this new Standard Operating Procedure will both meet the letter of the law and be structured so your company can implement effectively within the OPS system.

For more on OPS 4 SOPs, see my new videos posted here:

Email me to bring your company into the modern OPS era.


New Free Trade Certificate  --

Starting earlier this year Certificates of Free Sale (COFS) for food products regulated by the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) will be issued online as downloadable PDFs. The change from paper to PDF certificates will make the process of issuing COFS more efficient for both exporters and the agency.

Review of a certificate may be required by foreign countries as part of the process to import a product into those countries. FDA issues COFS for certain CFSAN-regulated food products upon request by an exporter. FDA does not require export certificates to export foods to foreign countries.

The FDA Certificate Application Process (CAP) is CFSAN's web-based application for accepting requests, reviewing, processing, managing, tracking, and administering CFSAN export certificates. To access CAP, log in to FDA Industry Systems at and select the "Certificate Application Process" option from the list of systems available. If you do not have an account with FDA Industry Systems, you will need to create one.

The advantages of CAP include:
  • Online submission of applications;
  • Reduction in application processing time;
  • Online receipt of certificates via PDF;
  • Real-time status updates via email and online tracking; and
  • Ability to copy, edit, and resubmit applications.

If exporters are unable to use the new PDF system, they may contact FDA and we will provide assistance.

CFSAN COFS will have a new look, including an updated letterhead and image of the HHS seal. PDF certificates issued directly to the applicant are considered original certificates and the Department of State is able to authenticate the certificates. For each certificate, FDA will provide a unique Certificate Identifier (ID). Foreign government officials authorized by the FDA can use this Certificate ID to verify the authenticity of the certificate. Exporters will need to ensure that the printed certificates are clear and legible. An example of the new look of the certificate is below.

If you have any questions or concerns, please email or call 240-402-2307.

Friday, August 18, 2017

Three New Vitamin Consultancy Videos

Three New Videos Updating Regulations
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3 Vitamin Consultancy Videos

My summer blockbusters will help preserve your natural product business.  Three videos -- two of which are my gift to you for being on this email list -- are Continuing Education (CEs) for the natural products industry.

The first features Robert Goodman PhD and me talking about our Cosmetic Safety Dossier service. In both the US and the EU third party safety certifications are an important part of successful cosmetics marketing. You can see the video on the CSD web site; click here:

The second is my explanation of the new OPS -- the Operating Procedures System -- which makes it simple to use your company's SOPs to actually run the business efficiently and in compliance with FDA requirements. This training video will be added to the Vitamin Consultancy Webinar system, but here it is for you now, gratis. Click here:

The third is my new Webinar on Quality Control The 26 slide presentation covers both FDA QC requirements and the qualifications needed for your QC Manager. Don't have a QCM? You need to watch this video. If you are the person who acts as QCM in your company, you need to watch it even moreso! Please email me for access: with QC Webinar in the subject line.

Have a great balance of the summer... winter holiday marketing starts soon!

ralph ...
Ralph Fucetola JD


Saturday, July 1, 2017

OPS for SOPs

Branding Basics

This Article Also Posted Here:

 Standard Operating Procedures and OPS

This newsletter describes the Standard Operating Procedures (SOP) Operating Procedures System (OPS) which the Vitamin Consultancy maintains for our monthly retainer clients. 
A New Vitamin Consultancy Service
Operating Procedures System - OPS
SOP Maintenance
Branding Profile

Dietary Supplement purveyors face an ever-changing regulatory climate as various federal agencies, led by FDA, seek to control the market. After practicing law for 36 years, gaining a reputation as The Vitamin Lawyer, I focused my efforts on The Vitamin Consultancy which brings top-level regulatory services to medium and small vitamin companies.

Those services include not only FDA-vetted, GMP compliant Standard Operating Procedure (SOP) formats, but also a webinar training program that teaches how to use SOPs to meet regulatory requirements -- and more, with specialized webinars on topics such as The Forbidden Words, to keep your company ahead of the curve. I provide GMP audits and copy/label/claims reviews.

In addition to keeping an eye on FDA regulatory developments through the Agency web site and various industry newsletters, I also have people coming to me for my advice who have been recently inspected by FDA and received "Comment" letters. Often these letters are an "early warning" of FDA regulatory focus, giving me the opportunity to prepare you for the changing regulatory environment.

As a result of some language used in a recent FDA letter to a company selling homeopathic patches, I saw that FDA was recommending certain language, in effect, for the Quality Control (QC) parts of the SOPs, more clearly specifying the role of the Quality Control Manager (yes, in a small company the CEO/COO may also be the QCM), so I created certain amendments to the SOPs to cover this new FDA focus and clarify the role of the QCM.This is one way for Vitamin Consultancy clients to stay a head of the curve. [BTW, I am working on a new webinar about the role of the QCM.]

While there is a Change Procedure in the SOPs, how will such changes be communicated and implemented?

I've been thinking, therefore, about how to more effectively automate the process.  I suggest it may be time to "go digital" with the Operating Procedures System -- OPS.

Using the paper file hard-copy as a back up, the company could have a private [password protected] online OPS copy as the official copy.

Even, or especially, in an emergency managers would have access to necessary procedures from their smart phones that would give them always up-to-date copies of the procedures.  Properly indexed with hyperlinks, the necessary information would always be available, and, perhaps more importantly, FDA would see that there is a system in place to ensure that the most up-to-date procedures are being implemented.

In addition to the SOP format that I've prepared there are probably other formal or informal operating procedures that should be recorded, not necessarily for FDA compliance, but for brand and operations consistency.

The Operating Procedures System could become a repository for the company culture, for such essential factors as the Company Branding Profile (see article below).

Properly developed and maintained, the OPS can be a valuable company asset.

The Vitamin Consultancy's SOP Maintenance System provides your company with a powerful tool for the continued regulatory compliance of your operations. Here is how it works:

1. The Company and the Consultancy enter into a privacy contract for the maintenance of the OPS. The maintenance fee is included in the monthly retainer.

2. The SOP document, based on the Consultancy format, is finalized with the Company and posted on the protected site. Only the OPS Administrator, provided by the Consultancy, has authority to change the document (and with company COO approval).  Additional operations documents that may be useful can also be posted, under COO direction.

3. The Company specifies which managers are to have access. That access is granted to specific email addresses and can be password protected. At any time access can be terminated.

4. The Consultancy will keep the SOPs up-to-date and will notify the managers, through the master list, of changes.

5. These procedures will themselves be set down in a new SOP specifying the OPS Online Official SOPs.

Here is an outline of the Operating Procedures System:

[1] The SOP document details the operating procedures of the Company, in conformity with FDA and FTC regulations of dietary supplement and similar businesses. See SOP Index below.

[2] The OPS is the private online repository for the updated official copy of the SOP document, available to the managers of the Company.

[3] The OPS consists of a Google Documents file folder and subfolders with the following items:
  1. The OPS Use Memorandum
  2. The SOP indexed manual consisting, currently, of 24 specific SOPs
  3. The SOP Appendix with standard forms
  4. The Company Branding Profile
  5. The CCDS (Company Core Data Sheet) for each current product.
 [4] The SOP Manual consists of the following procedures:

1.  Introduction / Index
2.  Refund, Delivery & Returns Policies
3.  Standard Disclaimers; Site Use Statement
4.  Standard Waivers: Model – Testimonial – Clinical Study
5.  Email Privacy Policy
6.  Document Retention Policy
7.  Quality Control / Claims Control / Complaints
8.  Contract Manufacturer Agreement GMP Enforcement Terms
9.  Password and Internet/Program Access Controls
10.  Order Processing Procedure
11.  Bookkeeping and Account Management
12.  Order Record Keeping and Retrieval; AER Reporting
13.  Emergency Planning and Crisis Management
14. Payment Card Industry Data Security System
15. Private Labeling / Labels
16. Receiving, Handling, Shipping & Storage of Inventory and Returns
17. Recalls
18. Complaint Form
19. Change Controls / New SOPs
20. CAPA
21. CCDS (Company Core Data Sheets)
22. New Employee Qualification and Training
23. Official Inspections: Procedures
24. New Product Development; Product Retirement & Archiving

[5] The SOP Appendix includes these forms:

Complaint Form
Contract Terms
Social Media Schedule / Program Access

[6] These are records are kept in the ordinary course of business and may be offered as evidence in court. The Branding Profile is an expression of the company’s Intellectual Property and claims to trademarks, trade dress and branding indicia.

[7] The following Positions in the Company are listed in the SOPs: the CEO, COO, Quality Control Manager (QCM), Emergency Manager (EM), SOP & CCDS Manager, Customer Service Manager and Warehouse Manager.

The COO or (where one is not designated) the CEO shall hold these Manager Positions unless the Positions are filled by appointment by the CEO

[8] All managers shall maintain online access to the current SOPs at all times; for example, on their smart phones.

[9] The private link to the OPS Google Docs folder which includes the SOPs can be provided to anyone in the company, or any consultant, who needs access to the OPS

Depending on company size, the Vitamin Consultancy can maintain your OPS and their contents for as little as an hour a month retainer. For that you receive our guidance on developing your SOPs, including FDA-compliant forms, your basic Company Branding Profile (more about that below) and our private client alerts regarding breaking FDA and FTC news impacting natural products. Of course, we set up and maintain your OPS online.

Interested? Call Ralph: 973.300.4594. We invoice monthly through PayPal. 


What is a company Branding Profile? It is an organized document that is part of the Intellectual Property of the company. It adds value to the company by better defining the company brand.

The Profile covers such issues as patents and trademarks, slogans; trade names and logos; precisely what colors represent the company; what typeface fonts; what types of images, the "look and feel" of the labeling and sales copy (trade dress; branding indicia). Standard advertising language may be cataloged. The Company Mission should be included.

One Branding Agency lists:

"The brand codification process typically involves defining and aligning elements like:
  • Target audience / segments
  • Target beliefs & perceptions
  • Target options / competitors
  • Category
  • Value proposition
  • Position
  • Speaking points
  • Personality
  • Selling points
  • Tone & manner
  • Visual profile
  • Backstory
  • Brand persona
  • Brand architecture
  • Vision, mission, goals"

The Branding Profile is intended to offer guidance to the copywriters and customer service people in the company, as well as the planners and managers.

That is why this essential part of the company culture rightfully belongs in the OPS, as one of the chief expressions of the company's mission.

Tuesday, May 9, 2017

First Amendment Food Claim

Fed Appeals Court Supports
First Amendment Food Claim

The FDA Law Blog reports: "The court rejected the state’s premise that any use of a defined term inconsistent with the state’s preferred definition is inherently misleading. “Such a per se rule would eviscerate Central Hudson, rendering all but the threshold question superfluous.” Instead, the court reviewed the Webster’s dictionary definition of “skim milk,” and concluded that consumers did not expect skim milk to meet the state’s “alternative definition.”"

The Decision states: "The State's mandate was clearly more extensive than necessary to serve its interest in preventing deception and ensuring adequate nutritional standards..."  Ocheese Creamery LLC v Putnam (11th Cir. 2017  - Case 16-12049 - Page 22, Slip Decision of 20 March 2017)*

So the question to ponder is this: if the courts will not show "deference" to a state government's imposed definition, will they continue to show deference to Federal Agency definitions of terms, such as the FDA's regulations that restrict speech based on their own definitions? Or will the common meaning of words now receive judicial sanction? Have we now won the right to use, for example, the word "heal"?

I recently wrote about Judicial Deference to agency determinations, and about Judge (now Justice) Gorsuch's pro-freedom views on this issue. The blog entry was written before Gorsuch was nominated to the Supreme Court. You can read it here:

Cosmetic Dossiers
The Essential FDA/EU Service
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.​

FDA on the Prowl...**

"On Tuesday, the agency responsible for policing the American food and drug market issued warning letters to 14 companies that it says are "illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.""

A word to the wise...

Recently got a call from a client who may have been pulled into this fracas! She says she hired an SEO company that put cancer claims in her metatags, about which she had no prior knowledge. Letting anyone who is not fully trained in the Allowed and Forbidden Words to touch the web site, even the hidden text, is risky.

This may mean a new FDA push against nutrient remedies is ramping up.  We need to keep the pressure up --

Countering this are recent court cases giving more leeway to "off label uses" I wrote about that last year:

That article explained:

"[T]ruthful and non-misleading commercial speech is constitutionally protected…"

Off-label pharmaceutical claims get First Amendment protection. What about structure & function or health claims for nutrients?

Can FDA discriminate against nutrients because they are not FDA-approved, but rather grandfathered under DSHEA? Articles from the FDA Law Blog and from Nat Law Review explore the Amarin case.

After reviewing the Injunction and several reports on it, I am of the opinion that “off label” use for Dietary Supplements cannot be prevented by FDA, so long as the claims are carefully presented as substantiated but not conclusive. That does not mean you can claim to “treat disease.”

It does mean that social media chatter and consumer review marketing can now be a bit more adventurous…


Voice of America reporting

An end-of-March Cape Town court ruling appears to legalize at-home cannabis use in South Africa. VoA quoted one of the parties to the law suit,

“So, if you are using cannabis in the privacy of your own home, or indeed if you have grown cannabis in the privacy of your home and it’s never left the building, you now have a loophole in the law that if you do get arrested and you do go in front of a magistrate, you can use the defense that you are hurting nobody, there was no victim, there was no crime, there’s no black market, there are no transactions, no one is making money out of this, you are using the cannabis you grew in the privacy of your own home,”

Call Me for Details - 973.300.4594

Thursday, April 13, 2017

You Must Adhere to GMPs

It's been over two months since my last newsletter...
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FDA Injunction: You Must Adhere to GMPs

Doesn't matter who the president may be; the FDA continues on its bureaucratic way. As does Congress. 
Just last month we faced a failed health care reform that could have restricted dietary supplement access. See more here: .
While Congress flounders, see this about an FDA warning letter that led to a Court Order Permanent Injunction that the company immediately cease all operations:
“Companies that market their products with unproven health claims and also continue to violate manufacturing regulations put consumers’ health in jeopardy,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “The FDA will take the enforcement actions necessary to protect consumers from this undue risk.”
"The FDA inspected X’s businesses, which shared a location, four times since 2012. Despite assurances from X that the deficiencies noted during the inspections would be corrected, follow-up FDA inspections revealed that X repeatedly failed to make the necessary corrections."
"Because X’s businesses failed to follow cGMP regulations, their dietary supplements are adulterated under the Federal Food, Drug, and Cosmetic Act. Some of the supplements were also mis-branded because X’s businesses failed to properly list on the products’ label the number of servings per container and the correct serving size per container. Additionally, they failed to list each ingredient contained in the dietary supplements and identify the part of the plant each botanical dietary ingredient was derived from...."

Bottom line: companies that market their own products that they manufacture or label will be held to all manufacturing, holding and shipping GMPs. They will be expected to document compliance. Standard Operating Procedures are an essential element to remain in business.

I have continued to upgrade and update the SOP and training system from The Vitamin Consultancy. Here is how I can help your company:

1. Preparing SOPs that reflect your actual business practices and that conform to GMPs
2. Designing Control Systems that implement the SOPs
3. Training your staff in implementing the SOPs (FDA says it is not enough to have standard procedures, they must be written and your staff must be trained in using them).
4. Auditing your procedures and your contract manufacturer's GMP compliance.
July 2017 Update:OPS 4 SOPs

More here: 
GMP Audits here:

Contact me any time. I'm available to set your mind at ease.

Ralph Fucetola JD

A personal note, for those of you who don't know already. My friend and mentor, General Bert Stubblebine, died on 6 February 2017, his 87th birthday, after 158 days in hospital. We recount his and Dr. Laibow's struggle to save his life against the expectations of the medical system here:
Full FDA announcement here:

Sunday, February 5, 2017

Era of the Mobile App

Mobile Apps, Cognitive Enhancement &
I'm on My Way to Texas in Two Weeks.
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The Era of the Mobile App is Upon Us!

This memorandum covers developing FDA regulations of Mobile Apps. To a great extent, the future of internet communication is via Apps. Some estimate that 80% of internet traffic will be Mobile App mediated by the end of the decade.
Bottom Line: The time to enter the Mobile App space may be now…
Here is an example of a Mobile App (for Dr. Rima Laibow) described here:
FDA Regs on Mobile Apps 
Some of the questions being considered by the regulators:
-         How the FDA should categorize mobile apps and decides how, or whether, to regulate them as medical devices.
-         How the FDA evaluates an app's "intended use."
-         How to interpret the FDA's promise of "enforcement discretion" for certain types of apps.
-         Who can be considered a mobile medical app developer and what regulations affect them.

Read more here:

I'll be in Houston and Austin Texas from February 19th to the 24th, meeting with various Vitamin Consultancy clients, associates and friends.

Highlight: a power meeting for If you are going to be in the Houston area on Monday, February 20th, I'd love to invite you to join us at Dr. Ed Group's Global Healing Center (set in a beautiful ecopark and bird sanctuary) just off I45 north of the City. We'll be meeting the Nutraspace Team and learning about their new health products and the power of the Nutraspace platform.
So happy to tell you about Pure Harvest Extraction taking on the Biologics Cognitive Enhancement products. These nutrients are just what we Baby Boomers... and even our younger compatriots... need! Check out the new site at

Sunday, January 15, 2017

FDA Mobile App Regulations

This memorandum covers developing FDA regulations of Mobile Apps. To a great extent, the future of internet communication is via Apps. Some estimate that 80% of internet traffic will be Mobile App mediated by the end of the decade.

Bottom Line: The time to enter the Mobile App space may be now…

Here is an example of a Mobile App (for Dr. Rima Laibow) described here:

FDA Regs on Mobile Apps

Some of the questions being considered by the regulators:

-         How the FDA should categorize mobile apps and decides how, or whether, to regulate them as medical devices.
-         How the FDA evaluates an app's "intended use."
-         How to interpret the FDA's promise of "enforcement discretion" for certain types of apps.
-         Who can be considered a mobile medical app developer and what regulations affect them.

FDA's evolving stance on Mobile Apps sorts them into three categories:

-         Administrative health information technology (e.g, billing, claims processing, general communication and scheduling): This is not a medical device and not regulated by the agency.

-         Health management information technology (e.g., medication management, data capture, electronic access to clinical results, provider order entry): This is under FDA jurisdiction but generally so low risk that the agency can exercise enforcement discretion and not apply regulations.

-         Medical device health information technology (e.g., computer-aided detection and diagnosis, robotic surgical planning, remote display of bedside alarms, radiation treatment planning): This is actively regulated under Class I, Class II and Class III medical device rules.

Here is what the FDA is saying about Mobile Apps:

The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery.

Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. These tools are being adopted almost as quickly as they can be developed. According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications ( -be-using-healthcare-mobile-applications-in-2015/). These users include health care professionals, consumers, and patients.

The FDA encourages the development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps.

The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB) on September 25, 2013, which explains the agency’s oversight of mobile medical apps as devices and our focus only on the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.

What are mobile medical apps?

Mobile apps are software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software.
Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance. For example, the National Institutes of Health’s LactMed app provides nursing mothers with information about the effects of medicines on breast milk and nursing infants.

Other apps aim to help health care professionals improve and facilitate patient care. The Radiation Emergency Medical Management (REMM) app gives health care providers guidance on diagnosing and treating radiation injuries. Some mobile medical apps can diagnose cancer or heart rhythm abnormalities, or function as the “central command” for a glucose meter used by an insulin-dependent diabetic patient.

How will the FDA regulate mobile medical apps?

The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices.  The guidance document (PDF - 269KB) provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A, Appendix B and Appendix C.
We encourage app developers to contact the FDA – as early as possible – if they have any questions about their mobile app, its level of risk, and whether a premarket application is required.

Mobile medical apps that the FDA will regulate

The FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of “device” and that:

-         Are intended to be used as an accessory to a regulated medical device, or
-         Transform a mobile platform into a regulated medical device.

Mobile apps span a wide range of health functions. While many mobile apps carry minimal risk, those that can pose a greater risk to patients will require FDA review.

For a list of what is considered a mobile medical application, manufacturers and developers of mobile applications can search FDA’s database of existing classification by type of mobile medical application  (for example diagnostic).  Approved/cleared mobile medical applications will also be listed in FDA’s 510(k) and PMA databases and on the FDA’s Registration & Listing Database.

FDA’s mobile medical apps policy does not require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes.

Mobile apps for which the FDA intends to exercise enforcement discretion

For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:

-         Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
-         Provide patients with simple tools to organize and track their health information;
-         Provide easy access to information related to health conditions or treatments;
-         Help patients document, show or communicate potential medical conditions to health care providers;
-         Automate simple tasks for health care providers; or
-         Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.

Does the FDA regulate mobile devices and mobile app stores?

FDA’s mobile medical apps policy does not regulate the sale or general consumer use of smartphones or tablets. FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers. FDA’s mobile medical apps policy does not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA.

Does the guidance apply to electronic health records?

FDA’s mobile medical app policy does not apply to mobile apps that function as an electronic health record (EHR) system or personal health record system.