FDA Warning Concerning Smelling Salts - MedWaste Management FDA Warning Concerning Smelling Salts - MedWaste Management

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FDA warning letter, illegal smelling salts, powerlifting

FDA Warning Concerning Smelling Salts

The FDA has issued a stark warning letter to Skull Smash, LLC. After a careful review of their website and product catalog, the FDA has determined that they are illegally distributing over-the-counter drugs. Their products, which they claim will boost mental clarity and alertness prior to competition, are classified as drugs under section 505(a) of the Federal Food Drug & Cosmetic Act. However, Skull Smash has failed to follow appropriate channels to gain approval prior to the distribution of the drugs online.

Skull Smash, LLC has 15 days to respond to the letter with appropriate action. Failure to do so may result in a drug recall. As of the writing of this notice, the company continues to manufacture and distribute the drugs illegally.

SUMMARY

Date of Warning:

Announced: March 13, 2024

Name(s) of Drug:

Various Smelling Salts

Company Name:

Skull Smash, LLC

Drug Indication:

Varies, see below.

About the Products

Skull Smash, LLC distributes its products online from its website, https://skull-smash.com/ammonia/blood-eagle. It targets power-lifting athletes and offers products such as Ammonia inhalants, chalk, coffee, and other merchandise. The products are distributed throughout the United States.

The FDA letter specifically concerns Skull Smash, LLC’s line of smelling salts, aka ammonia inhalants. Below is a list of those drugs.

Product Name

Skull Smash® Ammonia Inhalants
Badass Bitch
Double Barrel Ammonia Inhalants
Silver Bullet Ammonia Inhalants

FDA

Reason for Warning

According to the FD&C Act, all substances that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the body are considered drugs. Therefore, these substances must be approved by the FDA prior to distribution to the public. Approval is gained through a series of applications that determine if safety and efficacy have adequately been proven through a series of trials and studies. The drugs in question have not met these standards and are, therefore, being distributed illegally.

Warning Impacts

Consumers who purchase and use the unapproved drugs listed in the warning are placing themselves at high risk of poor health outcomes. It is currently unknown if these products are safe for use and, if so, at what dosage. Risks associated with exposure to high levels of ammonia include burning of the eyes, nose, and throat. This may result in blindness, damage to the lungs, or death.

This notice is urgent and consumers who have purchased substances from Skull Smash, LLC should monitor Med Waste Management for upcoming drug recalls related to the investigation.

Consumers

  1. Currently, the FDA has issued no official guidance on recalls or discontinuations of the medications. However, the drugs sold by Skull Smash, LLC may harm your health. Contact your physician immediately if you have been utilizing the drugs for further instructions.
  2. If you use any medications from this company, monitor your health for adverse symptoms and notify your physician of any concerns.
  3. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and inform the FDA by calling 1-800-332-1088 or completing an online reporting form.
  4. If your physician advises you to dispose of the medication, contact MedWaste Management for information and assistance with disposal.

Retailer

  1. Track drug recalls through the FDA or Med Waste Management websites.
  2. Notify affected consumers when the FDA announces the formal recall.
  3. Contact MedWaste Management for information and assistance with disposing of medications if necessary.

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Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!


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