infinite cbd

Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or by e-mail to [email protected]

Your “Absolute Zero 99%+ CBD Isolate,” “Freezing Point CBD Topical Cream,” “Afterglow Healing Oil 100mg CBD Total,” “Nano Enhancer Pure Nano CBD,” “Nano Freezing Point CBD Topical Cream,” “Asteroid Gummies,” “Sour Asteroid Gummies,” “Sweetened Dropper,” and “Nano Non Dairy Creamer,” products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) The aforementioned products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. FDA approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, under 21 CFR 201.100(c)(2) and 201.115, because no FDA approved applications are in effect for them. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

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Your “Pet Droppers” and “Launch Pad” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new animal drugs” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v). To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-l. These products are not approved or index listed by the FDA, and therefore these products are considered unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of these adulterated drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Examples of claims observed on your website https://infinitecbd.com/shop/ that establish the intended use of your products as drugs include, but may not be limited to, the following:

We note that your Asteroid Gummies,” “Sour Asteroid Gummies,” “Sweetened Dropper,” and “Nano Non Dairy Creamer” products appear to be promoted as conventional human food. For example, your labeling describes the products, variously, as “delicious,” “tasty treat[]”, “sweetened flavor,” and something that can be “[e]asily tossed into your lunch” or added to beverages. However, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,. FDA has concluded that the prohibition in section 301(ll) applies to CBD.1 There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. However, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), prohibits the introduction into interstate commerce of any food to which CBD has been added, but you may present FDA with any evidence bearing on this issue.

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On your product webpage for “Launch Pad

Hi Helen,
Thank you for your review of our Pet Droppers! We are thrilled to hear how well this product is helping to relieve insomnia and anti inflammatory issues. We appreciate your feedback and we look forward to doing business with you again soon!”

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 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.

On your webpage “Should I Use CBD Versus Opioids”:

Lakewood, Colorado, Sept. 11, 2020 (GLOBE NEWSWIRE) — Infinite CBD further expands upon their options with Hemp Flower and Vape Cartridges! With variants for both, the Infinite CBD knows that these additions not only build upon the customer experience, but offer service for those who prefer to inhale their cannabis products. While the company has previously focused on CBD isolate products, Hemp Flower and Vape Cartridges will be additions to their whole plant experience – alongside recent additions B12 Asteroids and Broad Spectrum Asteroids.

September 11, 2020 08:00 ET | Source: Infinite CBD Infinite CBD

Infinite Product Company in Colorado Expands Their Product Line with Smokable Options

Vape products within the cannabis industry are a hit. When preparing to launch Vape Pens, Vape Cartridges as well as batteries, Infinite CBD ensured something for everyone. Customers will have a choice between natural Apricot and Orange Ginger flavor. What makes their experience even more unique is that these flavor profiles are from naturally occurring terpenes. Shoppers can expect:

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Customers can expect these options to be available in both 3.5 and 7 gram quantities. However, the launches won’t stop there.