Sunflora, Inc./The CBD Store, LLC dba Uw CBD Store – 585390 – 22-11-2019

Sunflora, Inc./The CBD Store, LLC dba Uw CBD Store – 585390 – 22-11-2019

november 26, 2019 0 Door admin

Translating…


Delivery Method:
Via Overnight Delivery
Product:
Drugs

Recipient:

Recipient Name

Marcus Quinn

Recipient Title

President

Sunflora, Inc./The CBD Store, LLC dba Your CBD Store

8413 Laurel Fair Circle
Tampa, FL 33610
United States

Issuing Office:
Center for Drug Evaluation and Research | CDER

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


RE: 585390

Dear Mr. Quinn and Ms. Quinn:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://sunflora.org from July through October, 2019, and has determined that you take orders there for the products “Sunmed Tincture” (also referred to as “0 THC Tinctures”), “Sunmed Water Soluble” (also referred to as “Water Soluble – 0 THC”), “Sunflora CBD Daytime Ageless Moisturizer” (also referred to as “CBD Daytime Moisturizer”), “Sunflora CBD Nighttime Ageless Serum” (also referred to as “CBD Nighttime Face Serum”), “Sunmed Topical Relief Cream” (also referred to as “Topical Pain Cream – Peppermint”), “SunMed Bacon Dog Treats,” “SunMed Pet Bark Bits Beef,” “SunMed Dog Lamb Bits,” and “SunMed Pet Tincture,” all of which you promote as products containing cannabidiol (CBD). We have also reviewed your social media site at https://www.instagram.com/yourcbdstoreofficial/ and “Your CBD Store” website at https://www.cbdrx4u.com, which redirects consumers to your https://sunflora.org website to purchase your products. The claims on your websites and social media website establish that your “Sunmed Tincture,” “Sunmed Water Soluble,” “Sunflora CBD Daytime Ageless Moisturizer,” “Sunflora CBD Nighttime Ageless Serum,” and “Sunmed Topical Relief Cream” 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). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your “SunMed Bacon Dog Treats,” “SunMed Pet Bark Bits Beef,” “SunMed Dog Lamb Bits,” and “SunMed Pet Tincture,” products, which you promote as products containing CBD, are unapproved new animal drugs that are 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). FDA has also determined that your “SunMed Peach Rings,” “SunMed Sour Bears,” “SunMed Sour Worms,” and “SunMed Watermelon Rings” products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce your “SunMed Peach Rings,” “SunMed Sour Bears,” “SunMed Sour Worms,” and “SunMed Watermelon Rings” products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).

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. You can find specific information about how FDA regulates CBD at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-CBD.

Dietary Supplement Labeling

Information on your website at https://sunflora.org suggests that you intend to market your products that contain CBD as dietary supplements. However, your products cannot be dietary supplements because they do not meet the definition of dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded that, based on available evidence, CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement., There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplements definition under sections 201(ff)(i)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(i)(B)(i) and (ii), but you may present FDA with any evidence bearing on this issue.

Unapproved New Drugs

Based on our review of your websites, your “Sunmed Tincture,” “Sunmed Water Soluble,” “Sunflora CBD Daytime Ageless Moisturizer,” “Sunflora CBD Nighttime Ageless Serum,” and “Sunmed Topical Relief Cream” products 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 claims observed on your website https://sunflora.org that establish the intended use of your products as drugs include, but may not be limited to, the following:

On your product webpages for “Sunflora CBD Daytime Ageless Moisturizer” and “Sunflora CBD Nighttime Ageless Serum”:

  • CBD has been shown to promote abnormal cell death in certain skin conditions and long been used as a topical pain and anti-inflammatory solution.”

On your product webpage for “Sunmed Topical Relief Cream”:

  • “Topicals are meant for localized relief and are applied to the skin to aid in the relief of both pain and skin irritation.”
  • “Combining MSM, which has also been looked at as a possible treatment for pain relief in arthritis patients, with the anti-inflammatory and pain-relieving effect of both CBD and MSM, this cream is intended to provide strong pain-relieving effects.”

On your webpage titled “4 EASY WAYS TO IMPROVE YOUR HEALTH”:

  • “You can also add a CBD supplement, like any of the SunMed products, to help with minor aches that may come with exercise. It can improve the quality of the sleep you get and even help prevent conditions like diabetes and Alzheimer’s.”

Additional claims observed on your website https://www.cbdrx4u.com include, but are not limited to, the following:

On your webpage titled “About Your CBD Store®”:

  • “Rachel Quinn, Your CBD Store® founder, is one of many people who suffer from Crohn’s Disease. When prescription medications didn’t provide relief from the symptoms, a friend suggested she try CBD oil, which is a natural anti-inflammatory agent. She did, and within a few weeks the symptoms were under control and she had regained her quality of life.”

On your webpage titled “The Benefits of CBD”:

  • “U.S. government-funded research proves the CBD helps relieve inflammation, chronic pain, anxiety, psychosis, seizures, spasms, arthritis, diabetes, alcoholism, Multiple Sclerosis, schizo-phrenia [sic], PTSD, depression, antibiotic-resistant infections, epilepsy and other neurological disor-ders [sic].”
  • CBD has demonstrable neuroprotective and neurogenic effects, and its anti-cancer properties are currently being investi-gated [sic] at several academic research centers in the U.S. as well.”

On your webpage titled “Study finds CBD effective in treating heroin addiction”

  • cannabidiol, the non-psychoactive ingredient in hemp and marijuana, could treat opioid addiction, a new study says.”

On your webpage titled “SKIN CARE”:

  • “Topicals are meant for localized relief and is applied to the skin to aid in relief of both pain and inflammation of joints.”
  • “MSM—or Methylsulfonylmethane—which makes up part of the base of SunMed Topical Cream is a chemical found in green plants, animals, and humans; and has been research as an anti-inflammatory agent.”

On your webpage titled “Retail Watch: Chain offering CBD creams, gummies, oils and more blanketing the Lehigh Valley”:

  • “Whether you’re dealing with a common ailment such as anxiety, arthritis or migraines, or a more serious affliction such as cancer, multiple sclerosis or Alzheimer’s disease, a growing chain of CBD stores aims to naturally ease pain and hardships stemming from a wide array of health problems.”

Additional claims observed on your social media site https://www.instagram.com/yourcbdstoreofficial/ include, but are not limited to, the following:

  • May 7, 2019 posting – “I found some relief of my chronic pain . . ..”
  • March 31, 2019 posting – “I started taking Sunmed CBD consistently . . . for Anxiety and Depression . . . . This product gave me my life back.”
  • October 22, 2018 posting – The graphic with the headline “cannabidiol (CBD) Targets Symptoms Associated With: and numerous images for “Anxiety, Pain Relief, Arthritis, Diabetes, PTSD, Seizures, Chron’s Disease, Asthma.”

Your “Sunmed Tincture,” “Sunmed Water Soluble,” “Sunflora CBD Daytime Ageless Moisturizer,” “Sunflora CBD Nighttime Ageless Serum,” and “Sunmed Topical Relief Cream” 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). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the 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 and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-mentioned products. 

Misbranded Drugs

Your “Sunmed Tincture,” “Sunmed Water Soluble,” “Sunflora CBD Daytime Ageless Moisturizer,” “Sunflora CBD Nighttime Ageless Serum,” and “Sunmed Topical Relief Cream” 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).

301(ll) and Adulterated Human Foods

We note that your “SunMed Peach Rings,” “SunMed Sour Bears,” “SunMed Sour Worms,” and “SunMed Watermelon Rings” products appear to be promoted as conventional human foods. Specifically, these products contain a Nutrition Facts panel. 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. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD. 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 the 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 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.

According to your product labeling, your “SunMed Peach Rings,” “SunMed Sour Bears,” “SunMed Sour Worms,” and “SunMed Watermelon Rings” products are foods to which CBD has been added. Therefore, the introduction or delivery for introduction into interstate commerce of those products is a prohibited act under section 301(ll) of the FD&C Act.

You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term “food additive” refers to any substance the intended use of which results in its becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.   

Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act (21 U.S.C. 348(a)), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

There is no food additive regulation which authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in conventional foods. FDA’s regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).

We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS status. Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. Our review of publicly available data associated with the one FDA-approved CBD drug, as well as our review of published scientific literature, identified potential for liver injury from CBD and potentially harmful interactions with certain drugs. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males. Therefore, based on our review, the use of CBD in your products does not satisfy the criteria for GRAS status under 21 CFR 170.30.

FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food. Therefore, CBD added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Therefore, your “SunMed Peach Rings,” “SunMed Sour Bears,” “SunMed Sour Worms,” and “SunMed Watermelon Rings” products are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Unapproved New Animal Drugs

During our review of your firm’s websites, www.cbdrx4u.com and www.sunflora.org, FDA determined that your firm is marketing the unapproved new animal drugs “SunMed Bacon Dog Treats,” “SunMed Pet Bark Bits Beef,” “SunMed Dog Lamb Bits,” and “SunMed Pet Tincture.” Based on our review of your websites, your “SunMed Bacon Dog Treats,” “SunMed Pet Bark Bits Beef,” “SunMed Dog Lamb Bits,” and “SunMed Pet Tincture products 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 in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.   

Examples of claims observed on your firm’s websites, www.cbdrx4u.com and www.sunflora.org, that show the intended use of these products include, but are not limited to, the following:

On your product webpage, www.sunflora.org/pet-products.html for “SunMed Bacon Dog Treats,” “SunMed Pet Bark Bits Beef,” “SunMed Dog Lamb Bits,” and “SunMed Pet Tincture”:

  • “Just like humans, animals have the same endocannabinoid system that works with CBD to help support normal joint mobility and soothe nerves. It’s a must-have for dogs during stressful situations from thunderstorms or fireworks to going to the vet or being groomed… can also help pets after they’ve experienced a distressing event, such as separation anxiety, adoption, moving, or getting lost.”

On your product webpage, https://www.cbdrx4u.com/products/pet-products, for “SunMed Bacon Dog Treats” and “SunMed Dog Lamb Bits”:

  • “[I]f they are dealing with another condition due to injury, illness or old age, then talk to your vet about adding SunMed Canine Treats and Soft Chews to their treatment plan.”

On the “In The News” section of your website, https://cbdrx4u.com/in-the-news:

The post, “CBD oil may calm dogs made frantic by fireworks, local vet says”:

  • “Now, many pet parents are turning to Cannabis oil or CBD oil to calm down anxious pets.”
  • Dr. Lou Ann Ervin of Waco’s Texas Animal Medical Clinic says she has been prescribing it for her patients for about 6 months. Her first case was a puppy that suffered from epilepsy and anxiety.”
  • “We tried CBD oil for this little puppy and it worked great. It stopped the anxiety. They said she became a much better pet at home and more than that, the seizures stopped. So we’ve had them had her on this the whole time.” [sic]
  • “Ervin said the product is safe, non-addictive, and has a wide range of doses that can be used with other medications.”
  • “Ervin said CBD oil usually kicks in between 24 and 48 hours for seizures in dogs…For anxiety, she said it can kick in within half-an-hour.”

These products are “new animal drugs” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.

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).

301(ll) and Adulterated Animal Foods

Moreover, to the extent that you market any of your products containing CBD as animal food, 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 animal 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. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, as described above.

You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term “food additive” refers to any substance the intended use of which results in its becoming a component of any animal food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.

There is no animal food additive regulation that authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal foods. FDA’s regulations in 21 CFR 570.30(a)-(c) describe the criteria for eligibility for classification of an animal food ingredient as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30). We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal foods are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30. span> p>

Onder sectie 409 van de FD&C Act, 21 U.S.C. 348, wordt een additief voor diervoeding als onveilig beschouwd, tenzij het voorafgaand aan het in de handel brengen is goedgekeurd door de FDA voor het beoogde gebruik. CBD is niet goedgekeurd voor gebruik in diervoeding. Dierlijk voedsel dat een onveilig additief voor levensmiddelen bevat in de zin van sectie 409 is vervalst in de zin van sectie 402 (a) (2) (C) (i) van de FD&C Act. Introductie van een vervalst diervoeder in de handel tussen staten is verboden onder sectie 301 (a) van de FD&C Act, 21 U.S.C. 331 (a). Span> span> span> p>

De in deze brief genoemde schendingen zijn niet bedoeld als een allesomvattende verklaring van schendingen die bestaan ​​in verband met uw op de markt gebrachte producten. U bent verantwoordelijk voor het onderzoeken en vaststellen van de oorzaken van de hierboven geïdentificeerde schendingen en voor het voorkomen van herhaling of het optreden van andere schendingen. Het is uw verantwoordelijkheid om ervoor te zorgen dat uw bedrijf voldoet aan alle vereisten van de federale wetgeving, inclusief FDA-voorschriften. Span> span> span> p>

U moet onmiddellijk actie ondernemen om de in deze brief genoemde schendingen te corrigeren. Als deze schendingen niet onmiddellijk worden gecorrigeerd, kan dit leiden tot gerechtelijke stappen zonder verdere kennisgeving, waaronder, zonder beperking, inbeslagneming en gerechtelijk bevel. Span> span> span> p>

Breng de FDA binnen vijftien werkdagen na ontvangst van deze brief schriftelijk op de hoogte van de specifieke stappen die u hebt genomen om deze schendingen te corrigeren. Voeg een toelichting bij elke stap die wordt genomen om herhaling van overtredingen te voorkomen, evenals kopieën van gerelateerde documentatie. Als u van mening bent dat uw producten niet in strijd zijn met de FD&C Act, neem dan uw redenering en ondersteunende informatie ter overweging mee. Als u de corrigerende actie niet binnen vijftien werkdagen kunt voltooien, vermeld dan de reden voor de vertraging en de tijd waarbinnen u de correctie zult voltooien. Span> span> span> p>

Uw reactie moet worden gestuurd naar de Amerikaanse Food and Drug Administration, CDER / OC / Office of Unapproved Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51, Silver Spring , MD 20993-0002 of per e-mail aan FDAADVISORY@fda.hhs.gov a> .

Met vriendelijke groet,

/ S / p>

Donald D. Ashley
Directeur span> span> span> je zou
Kantoor van overeenstemming
Centrum voor geneesmiddelenbeoordeling en -onderzoek
Food and Drug Administration

/ S /

Eric Nelson
Directeur van overeenstemming

Office of Surveillance & Compliance
Centrum voor diergeneeskunde
Food and Drug Administration

/ S /

William A. Correll Jr.
Directeur je zou
Kantoor van overeenstemming
Centrum voor voedselveiligheid en toegepaste voeding
Food and Drug Administration


Bijvoorbeeld op uw webpagina met de titel “4 eenvoudige manieren om uw gezondheid te verbeteren, ”Zegt u“ U kunt ook een CBD-supplement toevoegen, zoals elk van de SunMed-producten. . . ”Op uw productpagina voor“ Topical Pain Cream met Pepermunt ”vermeldt u dat“ SunMed Broad Spectrum Hennepolie en SunMed Broad Spectrum Hennep Topical Cream bedoeld zijn als kruidensupplement. ”Op uw productpagina voor“ Sunmed Water Soluble “U verklaart dat” SunMed Broad Spectrum Hennepolie en SunMed Hennepolie Wateroplosbaar zijn bedoeld als kruidensupplementen. “

CBD is het actieve ingrediënt in het goedgekeurde geneesmiddel Epidiolex. Bovendien is het bestaan ​​van substantiële klinische onderzoeken met betrekking tot CBD openbaar gemaakt. Twee dergelijke substantiële klinische onderzoeken omvatten bijvoorbeeld de onderzoeken van GW Pharmaceuticals met betrekking tot Sativex en Epidiolex. (Zie Sativex begint VS Fase II / III klinische proef bij kankerpijn en GW Pharmaceuticals ontvangt nieuw onderzoeksgeneesmiddel (IND) van FDA voor fase 2/3 klinische proef met Epidiolex bij de behandeling van dravetsyndroom ). De FDA beschouwt een stof als ‘geautoriseerd voor onderzoek als een nieuw medicijn’ als deze het voorwerp is van een onderzoeksaanvraag voor nieuwe geneesmiddelen (IND) die van kracht is geworden. Volgens 21 CFR 312.2 is, tenzij een klinisch onderzoek voldoet aan de beperkte criteria in die verordening, een IND vereist voor alle klinische onderzoeken van producten die vallen onder sectie 505 van de FD&C Act. p>

We merken ook op dat de productpagina voor span > “Sunmed Topical Relief Cream” stelt dat het bedoeld is om “op de huid te worden aangebracht”. De FD&C Act definieert de term “voedingssupplement” in sectie 201 (ev) (2) (A) (i) als een product dat ‘bedoeld is voor inname’. Omdat deze producten niet zijn bedoeld voor inname, is dit een extra reden waarom uw ‘Sunmed Topical Relief Cream’ producten voldoen niet aan de definitie van een voedingssupplement volgens de FD&C Act.

Onder sectie 201 (s) van de FD&C Act (21 USC 321 (s) )), de volgende soorten stoffen zijn uitgesloten van de definitie van levensmiddelenadditieven: (1) chemische residuen van bestrijdingsmiddelen in of op een ruwe agrarische grondstof of bewerkte levensmiddelen, (2) chemische bestrijdingsmiddelen, (3) kleuradditieven, (4) gebruikte stoffen in overeenstemming met een “voorafgaande sanctie” (dat wil zeggen een sanctie of goedkeuring verleend voorafgaand aan de vaststelling van de wijziging van de levensmiddelenadditieven van 1958 onder de FD&C Act, de wet inzake de inspectie van pluimvee of de wet op de vleesinspectie), (5) nieuw dier medicijnen, en (6) voedingsingrediënten in of bedoeld voor gebruik in een voedingssupplement.

Onder sectie 201 (s) (5) van de FD&C Act (21 USC 321 (s) (5)), nieuwe diergeneesmiddelen zijn uitgesloten van de definitie van levensmiddelenadditieven. Als een nieuw diergeneesmiddel onveilig is in de zin van sectie 512 omdat het niet is goedgekeurd voor gebruik in dierlijk voedsel, wordt het dierlijk voedsel vervalst onder sectie 402 (a) (2) (C) (ii) van de FD&C Act. span> span> span> p> Div>


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