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WARNING LETTER

February 4, 2022

3211 SE Milwaukie Ave
Portland OR, 97202

RE: 620285

Dear Mr. Cady:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.crystalclearsupplements.com/ in December 2021 and has observed that you take orders for numerous products, including but not limited to “Tianeptine Sodium Powder,” “Tianeptine Sulfate Powder,” “PEA Capsules,” “Phenibut Capsules,” “Synephrine Powder,” “Noopept Powder,” “L-Theanine Capsules,” and “Lutein Capsules.” We also have reviewed your Facebook and Instagram social media websites at the Internet addresses https://www.facebook.com/crystalclearsupplements and https://www.instagram.com/ccsupplements/ respectively. These social media websites direct consumers to your website https://www.crystalclearsupplements.com/ to purchase your products. The claims on your website, social media websites and product packaging establish that your products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Furthermore, FDA has warned consumers about products containing tianeptine, which is used as a prescription drug in some European, Asian, and Latin American countries but is not an FDA-approved drug in the United States. The FDA is aware of several serious adverse event reports associated with tianeptine and that consumers may find themselves addicted to tianeptine.

Based on our review of your website, social media websites, and product packaging, your “Tianeptine Sodium Powder,” “Tianeptine Sulfate Powder,” “PEA Capsules,” “Phenibut Capsules,” “Synephrine Powder,” “Noopept Powder,” “L-Theanine Capsules,” and “Lutein Capsules” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

Examples of some of the claims observed on your website, your social media websites¹, and your products’ packaging that provide evidence that your products are intended for use as drugs include, but may not be limited to, the following:

“Tianeptine Sulfate Powder” and “Tianeptine Sodium Powder”

From the product packaging:
• “Stress Reducing
Mood Boosting”

From the product webpages at https://www.crystalclearsupplements.com/product/tianeptine-sulfate-powder/ and https://www.crystalclearsupplements.com/product/tianeptine-sodium-powder/:

• “Tianeptine . . . is an antidepressant agent that works by increasing serotonin uptake in the brain...”
• “Tianeptine’s success in treating depression is comparable to prescription medications but with less side effects and minimal risk of abuse. Tianeptine does not slow down cognitive function, cause sleeping problems, or cause weight problems.”

On your Facebook social media website at https://www.facebook.com/crystalclearsupplements:

• On your May 23, 2016 post: “Tianeptine may be used for relieving symptoms of depression, increasing cognitive ability and reducing anxiety. In July 2014 there was an unexpected discovery that tianeptine is a full agonist at the mu and delta opioid receptors with negligible effect at the kappa opioid receptors. . . #nootropics. . . #antidepressant. . . #antianxiety”

“PEA Capsules”

From the product webpage at https://www.crystalclearsupplements.com/product/pea-capsules/:

• “PEA, also known as β-phenylethylamine, 2-phenethylamine, and phenylethylamine, functions as a neurotransmitter in the human body. . . Because many amphetamines used to treat ADHD have many negative side effects, some naturopaths now recommend PEA instead of other stimulants to treat ADHD. PEA also has reported antidepressant effects.”

“Phenibut Capsules”

From the product webpage at https://www.crystalclearsupplements.com/product/phenibut-capsules/:
• “Phenibut is a derivative of the neurotransmitter GABA. . . is used to relieve anxiety, fear, tension, and to improve sleep. . . Medical research demonstrates the ability of phenibut to reduce anxiety as well as enhance cognitive performance. At higher doses, phenibut has tranquilizing effects and can suppress reactions to pain.”

On your Facebook social media website at https://www.facebook.com/crystalclearsupplements:
• On your June 2, 2016 post: “Phenibut is known as a GABA analogue. Outside the US many countries around the world use phenibut clinically for symptoms of PTSD, anxiety, depression and insomnia.”

On your Instagram social media website at https://www.instagram.com/ccsupplements/:
• On your February 27, 2017 post: “#nootropics #anxietyrelief” and “MOOD ELEVATION -ENHANCED SLEEP- HEIGHTENED FOCUS” on the product image.

“Synephrine Powder”

From the product webpage at https://www.crystalclearsupplements.com/product/synephrine-powder/:
• “Synephrine is known for its fat burning properties . . . Research indicates that synephrine elevates metabolic rates without increasing blood pressure or heart-rate.”

“Noopept Powder”

From the product webpage at https://www.crystalclearsupplements.com/product/noopept-powder/
• “Noopept powder is a nootropic with a molecular structure similar to racetams, known to be 1000 times more potent than the parent racetam, piracetam. Noopept is fast acting and provides a cognitive boost. . . has mild anxiolytic effects. . . . neuroprotective, has antioxidant abilities, and aids in blocking neurotoxicity. . . treat Alzheimer’s disease, meaning it has positive effects on memory and learning abilities.”

“L-Theanine Capsules”

From the product webpage at https://www.crystalclearsupplements.com/product/l-theanine-capsules/:
• “Tags: anxiety, . . . memory, mental performance, natural depression remedy”
• “Medical studies indicate that L-theanine is neuroprotective and can improve symptoms of depression, anxiety, insomnia, and cognitive impairment. . . . Scientific studies on animals demonstrate L-theanine’s ability to increase dopamine, GABA, and serotonin levels. One study suggests L-Theanine as a possible treatment of tobacco addiction because of its ability to inhibit the rewarding effects of nicotine and decrease the number of [sic] that can react to nicotine.”

“Lutein Capsules”

From the product webpage at https://www.crystalclearsupplements.com/product/lutein-capsules/:
• “Tags: cataract natural care, cataract natural cure, . . . eye natural treatment”
• “Lutein eye benefits include cataract care as well. Lutein is used to prevent cataracts and can, over time, improve vision for people with cataracts. Other studies indicate lutein may be beneficial for people suffering from heart disease, breast cancer, colon cancer, and type 2 diabetes.”
• “[f]ights oxidative stress and the damage it the [sic] stress can cause to the eye.”
• “Research indicates that lutein benefits those suffering from age-related macular degeneration (AMD) as well as prevent development of AMD.”

On your Facebook and Instagram social media websites at https://www.facebook.com/crystalclearsupplements and https://www.instagram.com/ccsupplements/ respectively:
• On your March 13, 2017 post: “Lutein can help prevent age related macular degeneration and cataracts.”

Your “Tianeptine Sodium Powder,” “Tianeptine Sulfate Powder,” “PEA Capsules,” “Phenibut Capsules,” “Synephrine Powder,” “Noopept Powder,” “L-Theanine Capsules,” and “Lutein Capsules” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps that you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so.

Your written reply should be directed to the U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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1 We note that although the cited drug claims from your social media sites were originally posted in 2016 and 2017, these posts are immediately accessible upon visiting your social media sites.