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Who Enforces Health and Safety Law?

Health and Safety laws are regulated by various agency officials and theses are arguably the most crucial jobs in our community. Most people do not take the time to adequately research their healthcare providers prior to receiving healthcare services or medication. However, several agencies have been established to safeguard and regulate the health and safety of the healthcare services that consumers receive. These agencies can’t replace individual due diligence but they make every attempt to prevent patient harm and to eliminate fraudulent activity in the healthcare system.

Florida Department of Health

The Florida Department of Health (DOH) was the first accredited public health system in the United States. Their mission is to protect and improve on the health of all people in Florida by regulating healthcare practitioners and facilities. They offer programs and services for the Florida community, but they are also responsible for the licensing and regulation of various healthcare practitioners and facilities. Various healthcare professions must be licensed and are regulated via the Florida Department of Health such as: medical doctors, acupuncturist, optometrists, and many more. Certain facilities such as piercing salons and pharmacies are also regulated by the Department of Health. Complaints can be filed against any of the practitioners or facilities, which will then be investigated by an officer for violations. The complaint is referred over to the Probably Cause Panel, which will determine whether to file an Administrative Complaint against the healthcare provider based on the weight of the evidence that is provided by the complainant and the provider who under investigation. It is not uncommon for the DOH to place an emergency restriction on a provider’s license if they pose an imminent danger to patient safety. If a violation is found, the Department of Health will determine appropriate disciplinary action to enforce the regulations, which includes, probation, suspension, or even revocation of a healthcare provider’s license.

Agency for Health Care Administration

The Agency for Health Care Administration (“AHCA”) was established in Florida to regulate the Medicaid system and healthcare providers who offer services to Medicaid beneficiaries. AHCA administers background screening, compiles healthcare data, and monitors the quality of care and civil rights complaints within healthcare facilities. They also license various healthcare facilities throughout Florida such as assisted living facilities, health care clinics, home health agencies, and many more.

Department of Health and Human Services

The Department of Health and Human Services has a family of agencies to provide services on local levels through state and county agencies. Some of these agencies include:

  • Centers for Medicare and Medicaid Services (“CMS”) proposes and publishes regulations yearly for those programs under medicare.gov, healthcare.gov, and more. CMS also enforces compliance with clearinghouses and healthcare providers and conducts audits regularly. CM provides health coverage to more than 100 million people through Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace. CMS seeks to strengthen and modernize the Nation’s health care system, to provide access to high quality care and improved health at lower costs.
  • The Centers for Disease Control and Prevention (“CDC”) is one of the most widely known organizations within the Department of Health and Human Services. The mission statement of the CDC to protect the America people from health, safety and security threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities and citizens to do the same. CDC increases the health security of our nation. As the nation’s health protection agency, CDC saves lives and protects people from health threats. The CDC conducts critical science and provides health information that protects America against expensive and dangerous health threats, and responds when these arise. This is a science based organization that works to protect communities from health threats. The U.S. Secretary for Human and Health Services has authorized the CDC to carry out and enforce functions for isolation and quarantine to prevent exposure to contagious diseases.
  • The Office of Inspector General (“OIG”) is another department within the Department of Health and Human Services that works to improve the efficiency of many health based programs. They are the largest office in the Federal Government. They investigate complaints based on fraud, waste, abuse, and misconduct. The majority of the agency’s resources go towards the oversight of Medicare and Medicaid — programs that represent a significant part of the Federal budget and that affect this country’s most vulnerable citizens. The OIG has the authority to exclude individuals and entities from Federally funded health care programs for a variety of reasons, including a conviction for Medicare or Medicaid fraud. Those that are excluded can receive no payment from Federal health care programs for any items or services they furnish, order, or prescribe. This includes those that provide health benefits funded directly or indirectly by the United States (other than the Federal Employees Health Benefits Plan).
  • The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA conducts research on various food and drug safety protocols. They create reports to share with the general public to spread accurate information. The FDA also works closely with drug manufacturers to ensure the production of safe and effective drugs. They are accountable for overseeing quality control, delays, and discontinuations of drugs and medications. The agency works closely to reduce or prevent shortages. The supervision and regulation of the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors is also a crucial role played by the FDA.

 

These are just a few of the hundreds of agencies established to protect our communities from safety and health emergencies. Each agency regulates their own sections within each community or program.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

 

Does the FDA consider Aromatherapy and Essential Oils a Cosmetic or a Drug?

Essential Oils Product Descriptions: Am I a Cosmetic of a Drug?

Whether an aromatherapy product is a cosmetic or a drug under the law is determined by the product’s intended use. The Federal Food, Drug and Cosmetic Act defines “cosmetics” 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.” Florida Statute §499.003(12) adopted the FDA’s definition of “cosmetic” verbatim, but further stated that the definition does not include soap. The law doesn’t require cosmetics to have FDA approval before they go on the market. But FDA can take action against a cosmetic on the market if they have reliable information showing that it is unsafe when consumers use it according to directions on the label, or in the customary or expected way, or if it is not labeled properly.

The FDA Act defines “drugs”, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or help you sleep are drug claims.

Intended use may be established by claims stated on the product labeling, what consumers expect it to do, in advertising on the internet, or in other promotional materials. Ultimately, the FDA makes decisions on a case-by-case basis. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. It may also be established that a product is a drug based upon the ingredients that have a well-known therapeutic use.

Essential oil fragrances marketed for promoting attractiveness is a cosmetic. However, a fragrance marketed with certain “aromatherapy” claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Under Florida Statute §499.005(5) it is a crime to disseminate false or misleading advertisement of a drug, device or cosmetic, which is punishable as a misdemeanor of the second degree. It is also a violation of the Florida Drug and Cosmetic Act to disseminate any false advertisement of any drug, device or cosmetic, which includes misleading advertisements according to Florida Statute §499.0054(1)(a). These advertisements include those on a website or social media account. Keep in mind that a cosmetic product must be labeled according to cosmetic labeling regulations.

It’s important to note that the FDA regulates labeling for cosmetics and drugs but advertising claims are regulated by the Federal Trade Commission. No cosmetic such as essential oils may be labeled or advertised with statements suggesting that FDA has approved the product. Under Florida Statute §499.003(2), “advertisement” is defined as any representation disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase of drugs, devices, or cosmetics.

In 2014, the FDA sent a warning letter to an essential oils company called Young Living and stated that some of their products that were marketed on their websites and social media accounts were promoted to treat conditions which caused them to be viewed as drugs. These products included “Cinnamon Bark,” “Oregano,” “Rosemary,” “Sandalwood,” “Peppermint,” “Frankincense” and others. The FDA argues that these are “new drugs” because they are not generally recognized as safe and effective for the intended use under the conditions prescribed, recommended or suggested in the labeling in the Young Living case. If you intend to market and describe these products as some type of treatment or disease prevention then you would need to seek FDA approval first. Further if used for those purposes, they would have to be provided under the supervision of a practitioner licensed by law to administer it. If you don’t make any medical claims in your advertisements you likely won’t trigger any action by the FDA or FTC.

Also, in 2014, the FDA sent a warning letter to another essential oils company called DoTerra for marketing its products that they claimed would treat, diagnose, cure, mitigate and prevent medical conditions.

You should avoid using language such as, “It has some crucial medical benefits as well” and “relieving medicine”  in the product details for your products.  Refrain from making claims that these products will  reduce stress-related headaches, reduce or eliminate acne problems, help with sleep, cure food poisoning.

Also, I would suggest that you include a Disclaimer for both product details and any blog posts. You should include in the disclaimer that says something like “The information in this post about essential oils is not intended to diagnose, cure, mitigate, treat or prevent any disease. According to the FDA, only drugs can make those types of claims, which these products on our website are not.”

Typically, any products marketed as “antibacterial,” “antiseptic,” “antiviral,” “anti-inflammatory,” “ant-cancer,” or “antimicrobial” are drugs according to the FDA. If a product is intended to affect the structure or function of the body, or for a therapeutic purpose, such as treating or preventing disease, they’re drugs. Avoid using these words in descriptions or blog posts or else you risk receiving a warning letter from the FDA.

You should avoid making claims like “Essential oils are the natural remedies for curing damaged skin and tightening loose skin” or that “essential oil has tremendous health benefits” . This implies some type of medical benefit and you do not want to make those types of claims. Simply avoid making any medical treatment, diagnosis or preventative claims. This is true even if these are not included in product  descriptions but in blog posts on your website or social media posts. Making research claims that any individual product may treat  ailments or diseases on your blog or social media may also  result in a warning letter issue to you from the FDA. Instead of using words like “treat” you should try using “rejuvenate,” “revitalize” or “reinvigorate” because those aren’t really medical terms.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Florida Senate Bill 8-A’s Effect on Physicians’ Medical Marijuana Practices

Background

President Trump he has not taken a firm stance publicly in favor of or opposed to the use of medical marijuana. Currently, he intends to leave the medical marijuana issue up to the individual states. The 2016 fiscal year  omnibus appropriations bill appears to be in line with Trump as it contains language prohibiting the Department of Justice from meddling in state medical marijuana laws.

According to a Department of Health report, the state registry now has 16,614 patients. A recent state revenue impact study projects that by 2022 there will be approximately 472,000 medical marijuana patients and $542 million in sales.

Many activists expect that there will be several lawsuits related to SB8A. Legislators anticipated this and have added language that divides SB8A so that if certain parts are held unconstitutional the court would only invalidate those parts without invalidating the entire law.

Qualified Physician

Under SB8A, a “qualified physician” is a person who holds an active and unrestricted license to practice medicine in compliance with the physician education requirements. In order to be approved as a qualified physician, the physician must successfully complete a 2-hour course and exam by either the Florida Medical Association or the Florida Osteopathic Medical Association. The exam will not cost more than $500. This requirement also applies to those seeking to become Medical Directors in medical marijuana treatment centers (“MMTC”).

A “Medical Marijuana Treatment Center” means an entity that acquires, cultivates, possesses, processes (including development of related products such as food, tinctures, aerosols, oils, or ointments), transfers, transports, sells, distributes, dispenses, or administers marijuana, products containing marijuana, related supplies, or educational materials to qualifying patients or their caregivers and is registered by the Department. As you can see, the definition of an MMTC is very broad and includes virtually every type of business in the medical marijuana industry.

A qualified physician may not be employed by, or have any direct or indirect economic interest in, a medical marijuana treatment center or marijuana testing laboratory. This sentence is important because it means that not every physician is bound by this rule. If you are a physician and you have not taken the course and exam to become certified so that you can certify marijuana to your terminally ill patients then this law doesn’t apply to you. For example, if you are a dermatologist who does not treat any terminally ill patients and you are not a “qualified physician” for purposes of providing marijuana to terminally ill patients then you are not prohibited from being employed by or having an economic interest in an MMTC or marijuana testing laboratory (“MTL”). An MTL or “Independent testing laboratory” means a laboratory, including the managers, employees, or contractors of the laboratory, which has no direct or indirect interest in a dispensing organization.

This aforementioned provision of SB8A places broad limits on the types of marijuana facilities and businesses that a qualified physician is permitted to have a financial interest in. MMTCs and MTLs are off-limits to qualified providers. Non-Qualified providers are thus able to work for or have a financial interest in medical marijuana retailers, medical marijuana delivery devices, and medical marijuana delivery companies to name a few.

A qualified physician may not authorize a patient to receive more than three 70-day supply limits of marijuana. However, a physician may request an exception to the daily dose amount limit electronically. Further, a physician must evaluate an existing patient at least once every 30 weeks prior to issuing a new physician certification.

Physician Certification

Physician’s Certification means that a physician may authorize a qualified patient to receive marijuana and a marijuana delivery device (i.e. vape pen) from a MMTC. A physician may certify that a patient is in need of medical marijuana only after she has:

  • Conducted a physical examination while physically present in the same room as that patient (Telemedicine is not permissible) and recorded a full assessment of the medical history of the patient.
  • Diagnosed the patient with at least one qualifying medical condition.
  • Determined that the use of medical marijuana would likely outweigh the potential health risks for the patient and it is documented as such in the patient’s medical record. If a patient is under 18 years old, a second physician must concur with this determination, and it too must be documented in the patient’s medical record.
  • Determined that the patient is pregnant. A pregnant patient may only receive low-THC cannabis.
  • Reviewed the patient’s controlled drug prescription history in the prescription drug monitoring program database.
  • Reviewed the medical marijuana use registry and confirmed that the patient is not currently receiving medical marijuana from another qualified physician.
  • Registers as the issuer of the certification to the patient on the medical marijuana use registry.
  • Obtains the voluntary and written consent of the patient, or their parent or legal guardian if they are a minor, only after the physician has sufficiently explained its content, for the medical use of marijuana each time the physician issues the certification to the patient.

A physician certifying the use of medical marijuana for their patient must use a standardized informed consent form adopted by the Board of Medicine or Board of Osteopathic Medicine, which must include, at a minimum the following:

  1. The Federal Government’s classification of marijuana as a Schedule I controlled Substance.
  2. The approval and oversight status of marijuana by the Food and Drug Administration.
  3. The current state of research on the efficacy of marijuana to treat the qualifying conditions.
  4. The potential for addiction.
  5. The potential effect that marijuana may have on a patient’s coordination, motor skills, and cognition, including a warning against operating heavy machinery, operating a motor vehicle, or engaging in activities that require a person to be alert or respond quickly.
  6. The potential side effects of marijuana use.
  7. The risks, benefits, and drug interactions of marijuana.

That the patient’s de-identified health information contained in the physician certification and medical marijuana use registry may be used for research purposes.

Medical Marijuana Use Registry

Physicians should be aware that a review panel will be created by their respective Boards to review all physician certifications submitted to the medical marijuana use registry. The panel will track and report the number of physician certifications and the qualifying medical conditions, dosage, supply amount, and form of marijuana certified. The panel will report the data by individual physician and in aggregate formats by county and statewide. On the surface, it appears that the Board is just collecting data from those who certify patients to receive medical marijuana. However, it also appears that the Board is analyzing patterns and potential abuse by physicians who over prescribe or prescribe at a much higher rate than other qualified physicians that are similarly situated. At this time, I am not sure what action the Board would take if any, if they determine that there is some irregularity with the prescribing pattern of a particular physician.

The medical marijuana use registry must be accessible to qualified physicians and MMTCs to verify the authorization of a qualified patient or a caregiver to possess marijuana or a marijuana delivery device and record the marijuana or marijuana delivery device dispensed. The goal of the registry is to prevent an active registration of a patient by multiple physicians who can then receive and possess an amount of marijuana that exceeds the legal limits. The fear is that this will lead to an abuse of the Schedule I drug.

Penalties

SB8A doesn’t contain many penalties for physicians apart from the other laws and Board rules that currently exist to which physicians are bound by. However, I’m confident that with the proliferation of medical marijuana use by terminal patients and the tracking of prescribing patterns by the Board that there will be additional penalties for physician-owners and qualified physicians on the horizon. A qualified physician who issues a physician certification for marijuana or a marijuana delivery device and receives compensation from a MMTC related to the issuance of the physician certification for marijuana or a marijuana delivery device is subject to disciplinary action under the applicable practice act and Fla. Statute. 456.072(1)(n).

 

***This blog post does not constitute legal advice and is only intended for educational purposes only. You should consult a licensed attorney in the State of Florida that specializes in healthcare law.***

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