TEK Naturals MARCS-CMS 565026 - February 05, 2026 > 자유게시판

This is to advise you that the U.S. As explained further below, introducing or delivering these products for Alpha Drive Rx supplement introduction into interstate commerce for such uses violates the Act. "Green Tea Extract … Green Tea’s polyphenols are scientifically proven to … "Green Coffee Beans … •"BurnerTEK includes scientifically-researched, consistent potencies of the following … "Green Tea Extract … "Green Coffee Beans … " . . . "Cayenne Pepper … has been the treatment of ear infections … … Turmeric also helps combat the effects of obesity, notably inflammation… "L-Carnitine plays a vital role in the reduction of blood glucose levels… Type 2 Diabetes…. Chromium Picolinate supplies the body with its essential supply of elemental chromium. •"Mind IgniteTM is a safe and highly effective alternative to Adderall. •"Adderall and similar drugs used to treat ADD and ADHD, are among the most abused drugs in the U.S. •"The ingredients in Mind Ignite …

"…Bacopa Monnieri is a natural … "Ginkgo Biloba is known to … "L-Tyrosine is an important amino acid that can … … counteract the symptoms of ADHD… "St. John’s Wort Extract … … anxiety. It also has been known to alleviate symptoms of ADHD… "One particular clinical study of Korean Ginseng was done on a group of 45 impotent men. "Muira Puama … has the ability to fight … "Yohimbe Bark Extract is actually used in a large number of countries as a prescription drug for erectile dysfunction.… "Vitamin B5 is essential because it helps regulate cholesterol… "Siberian ginseng … has long been used to … Your post states, "Check out this all new detailed review of our … The linked article, which you endorsed, contains evidence of intended use in the form of a personal testimonial recommending or describing the use of Mind Ignite for the cure, mitigation, treatment, or prevention of disease.

•"I became addicted, right at the point that Adderall lost its effect.… I came across brain supplements, better known as nootropics, while researching natural ADHD cures. I was hesitant at first, however, after trying a few well-reviewed ingredients, my mind began to change … •"I take Mind Ignite every day. I have struggled with ADHD for many years and took Adderall but stopped because of the side effects. My friend recommended Mind Ignite and it works for me… •Ginkgo Biloba Extract … •On January 16, 2018, your post states, "Still getting great reviews for … •"Green Coffee Bean Extract … •On September 24, 2017: "Ever heard of nootropics? Your product Mind Ignite is described on its product page as a nootropic. •On July 9, 2017: "Here is a list of the major benefits men in our studies have reported experiencing since they started using TEKMale… FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

"Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. Your products BURN4Her, BurnerTEK, Mind Ignite, TEK Male, and TestoTEK are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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 correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.