September 2020 FDA Warning Letters

As the coronavirus pandemic continues without a vaccine, many companies are promoting their products and services as cures and treatments. As of October 2020, FDA has not approved any medications for treating COVID-19. Companies that make such curative claims on their websites, on social media, and in other promotional materials are likely to receive an FDA warning letter (from the agency’s Office of Unapproved Drugs and Labeling Compliance) that their product and services are adulterated drugs and are misbranded. The FTC is also sending warning letters, often jointly with FDA warning letters.

The warning letters generally give the respondents a limited time to either cease making unwarranted claims or provide evidence why the claims are valid. Companies that continue making unapproved claims may face legal complaints which seek financial damages and injunction requests.

A few recent FDA warnings detailing these improper claims follows.

Pharmacy Plus, Inc. dba Vital Care Compounder

An FDA warning letter was sent to this Mississippi company on September 9, 2020 from the FDA Center for Drug Evaluation and Research. The warning letters stated that FDA and FTC review of the company website was conducted on several dates.

FDA’s website review noted that Pharmacy, Plus, Inc. dba Vital Care Compounder offered products called “COVID PACK” and “COVID ‘POSITIVE’ PACK” for sale in America. These products were offered as products which could “mitigate, prevent, treat, diagnose, or cure COVID-19.”

FDA determined that these products violate section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because the products are unapproved new drugs. The drugs are also misbranded in violation of section 502 of the FD&C Act. Further, introducing or delivery these products into interstate commerce violates sections 301(a) and (d) of the FD&C Act.

Currently, FDA and FTC noted that the pandemic is “caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19).

A public health emergency was declared by the Department of Health and Human Services (HHS) on January 31, 2020. The President declared a national emergency due to COVID-19 on March 13, 2020. In response to these emergency declarations, FDA is working aggressively to protect consumers from false claims that products, without FDA approval or authority, can “mitigate, prevent, treat, diagnose, or cure COVID-19 in people.”

Examples of claims made by the respondent – that the respondent’s products are safe and/or effective COVID-19 treatments

FDA noted the following misleading website claims:

• “Your product name, “COVID PACK.”
  • On the product page for “COVID PACK” you include the following statement:
    • “This supplement pack contains a 14 day supply of four physician recommended supplements for prophylaxis, treatment and recovery from the Covid-19 virus.”
• Your product name, “COVID ‘POSITIVE’ PACK.”
  • On the product page for “COVID ‘POSITIVE’ PACK” you include the following statement:
    • “This kit contains the standard covid kit comprised of Vitamin D3, Vitamin C, Zinc and Melatonin but also includes a 14 day supply of Nattokinase 100mg . . . routinely prescribed for covid positive patients. Ideal to keep in the home for emergency use when a family member tests positive for the virus.”

What does the FDA warning letter demand?

The FDA warning letter requires that that the pharmacy company:

• Ensure that all their products comply with the FD&C Act and FDA’s implementing regulations
• Review the company website, product labels, and promotional materials to ensure the company isn’t misleading the public by representing that the products are “safe and effective for a COVID-19-related use for which they have not been approved by FDA”
• The company not make any claims that cause the products to be misbranded

The company was given just 48 hours to respond by detailing what correct steps the respondent was taking. Including steps to prevent a repeat of the violations.

In addition FDA informed the respondent that the company will be added to an FDA website list of firms and websites that have received FDA warning letters about the sale/distribution of COVID-19 related products in violation of the FD&C Act.

If the company does take corrective steps, the published list will be updated to reflect that corrective steps were taken.

The FDA warning letter advised the respondent that the respondent could also:

• State the reason why the respondent needs more time to come into compliance
• State why the company believes the respondent is not in violation of the FD&C Act – which requires including their reasoning and supporting documents

The FTC part of the warning letter stated that the FT&C Act makes it unlawful to “advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.”

Since no there is no current COVID-19 approved study which is supported by reliable scientific evidence, the company was advised to immediately stop making false claims.

The warning letter states that FTC Act violations could result in:

• A federal district court injunction
• An order to pay back all money to consumers

The FTC time limit for reply was also set at 48 hours.

Medication-house.com warning letter

On September 2, 2020, the FDA Center for Drug Evaluation and Research, sent a warning letter to Medication-house.com.

This FDA warning letter was sent based on an August 10, 2020 review of the company website by the US FDA. The warning letter stated that the website offered products for sale in the US – which were, “intended to mitigate, prevent, treat, diagnose, or cure COVID‐191 and a variety of other diseases such as bacterial infections, including infections of the respiratory tract, genitourinary system, gastrointestinal tract, and skin and soft tissues.”

The warning letter stated that the products were being sold in violation of the FD&C Act because the products were

• “Unapproved new drugs”
• “Misbranded drugs”
• Offered for sale in interstate commerce

The warning letters stated that there were multiple drugs that violated the FD&C Act for these reasons.

FDA is especially concerned about unapproved and misbranded drugs that claim, “the mitigation, prevention, treatment, diagnosis, or cure of COVID‐19.” “Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.”

Unapproved New Drugs.

Some of the medication-house.com products are drugs, “because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body.”

The products are “new drugs” “because the products are not generally recognized as safe and effective for their labeled uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.”

Some of the statements from the company website that indicate the company products are unapproved new drugs include:

“Arbidol [a product listed on the website] inhibits the activity of influenza A and B viruses, as well as the coronavirus associated with severe respiratory syndrome. The active substance stimulates the humoral and cellular immune responses, which helps to increase resistance to viral infections.”

Currently there are no approved drug applications for Arbidol. FDA has not approved any drug “for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID‐19.”

Another example, noted in the warning letter, was that the company offers amoxicillin which the company describes as “antibacterial, bactericidal, acid-resistant, broad‐spectrum agent from the group of semi‐synthetic penicillins.” Furthermore, according to your website, “[Amoxicillin is] [a]ctive against gram‐positive bacteria…”

While amoxicillin does have an FDA-approved version – none of these versions are in effect for “amoxicillin offered by www.medication‐house.com.” For starters, FDA-approved amoxicillin requires a prescription.

The warning letter included other examples of unapproved new drugs offered on the company website.

Misbranded Drugs

According to the FD&C Act, a drug is misbranded “if it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended.”

Specifically, prescription drugs, according to the FD&C Act,

 “Include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them.”

A licensed practitioner must direct and supervise the use of prescription drugs according to the FD&C Act. The drugs listed in the unapproved new drug section, such as amoxycillin, are prescription drugs because the drugs are “intended for conditions that are not amenable to self-diagnosis and treatment by a layperson.” Adequate directions cannot be written such that a layperson can use the products safely for their intended uses.

Therefore the drugs listed on the website are improperly labeled because the drugs don’t have “adequate directions for their intended uses. This in turns means the drugs are misbranded (improperly labeled), under the FD&C Act.”

The warning letter adds that the letter doesn’t identify all the ways the company products or operations might violate the law. The company is the entity responsible for ensuring that all the products the company offers comply with the FD&C Act and the regulations that implement that law.

The requirements the drug company, Medication-house.com must complete to comply with the FDA warning letter

The warning letters states that the company must “take prompt action to correct the violations noted above as well as any other violations of the FD&C Act (which would include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above).” The letter also advised the company to review its entire website, labeling, and promotional materials for other misleading representations about product safety and effective uses which are not FDA approved. The company must make sure its claims don’t qualify as misbranding – in violation of the FD&C Act.

The warning letter advised the respondent that, within 48 hours, the respondent must send an email detailing what correct steps the company was taking to address the violations and to prevent recurrences. The email should include an explanation of each step being taken to remedy and prevent the recurrence of violations, as well as copies of related documentation.

If the company fails to send a corrective email, further legal action could include a seizure and injunction.

The warning letter did add that the company could:

• Indicate why the respondent needed more time to respond
• Provide detailed information and reasoning for why the company believes its products don’t violate the FD&C Act.

FDA and FTC warning letters are continually being sent to companies that are trying to profit from the COVID-19 health crisis. Since FDA has not approved any drugs or treatments for COVID-19, claims that company drugs can treat, cure, or control the deadly virus will be considered adulterated new drugs and misbranded drugs. Failure to comply with these warning letters can result in substantial penalties.

Drug makers and other medical companies should contact Cohen Healthcare Law Group, PC for legal advice on FDA and FTC compliance. Our experienced healthcare attorneys help clients take proactive compliance steps as well as responsive compliance steps.