WARNING LETTER
Organix Industries, Inc. dba Plant Organix
MARCS-CMS 593512 —
November 22, 2019
Delivery Method:
Via Overnight Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Shiloh Thibodeaux
Organix Industries, Inc. dba Plant Organix
2601 Del Rosa Avenue North
Suite 112
San Bernardino
,
CA
92404
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Ms. Thibodeaux:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at
www.plantorganix.com
in October 2019 and has determined that you take orders there for the products “
Classic Peanut Butter 300 mg CBD,” “CBD Hibiscus Tea,” “Banana Chips 300 mg CBD,” “Kiwi 300 mg CBD,” “Pineapple 300 mg CBD,” “Mango 300 mg CBD,” “Chili Mango 300 mg CBD,” “Apple Rings Gummies,” “Watermelon Sours Gummies,” “Sour Brats Gummies,” “Peach Rings Gummies,” “Gummy Bears Gummies,” “Pain Roll – Pain Oil,” “CBD Sleep Tincture,” “Meraki Intense Pain Balm/Lidocaine,” “Meraki Lotion,” “Meraki Lip Balm,” “Meraki Pain Salve” (500mg and 1000mg versions), “Natrual Tincture” and “CBD Tincture” (aka “MCT Oil Tincture”),
all of which you promote as products containing cannabidiol (CBD).  We have also reviewed your social media websites at
www.facebook.com/plantorganixwellness
and
www.instagram.com/plantorganix_edu
; these websites direct consumers to your website,
www.plantorganix.com
to purchase your products.  The claims on your website and social media websites establish that your Classic Peanut Butter 300 mg CBD,” “CBD Hibiscus Tea,” “Banana Chips 300 mg CBD,” “Kiwi 300 mg CBD,” “Pineapple 300 mg CBD,” “Mango 300 mg CBD,” “Mango Chil 300 mg CBDi,” “Apple Rings Gummies,” “Watermelon Sours Gummies,” “Sour Brats Gummies,” “Peach Rings Gummies,” “Gummy Bears Gummies,” “Pain Roll – Pain Oil,” “CBD Sleep Tincture,” “Meraki Intense Pain Balm/Lidocaine,” “Meraki Lotion,” “Meraki Lip Balm,” “Meraki Pain Salve (500mg and 1000mg versions),” “Natrual Tincture” and “CBD Tincture (aka “MCT Oil Tincture”)” 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 “Hemp Pet Tinctures” and “Hemp Pet Treats” products 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 “Banana Chips 300mg CBD,” “Mango 300mg CBD,” “Chili Mango 300mg CBD,” “Kiwi 300mg CBD,” “Classic Peanut Butter,” “CBD Hibiscus Tea,” “Apple Rings Gummies,” “Watermelon Sours Gummies,” “Sour Brats Gummies,” “Gummy Bears Gummies,” “Peach Rings Gummies” and “Pineapple 300mg CBD
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 ““Banana Chips 300mg CBD,” “Mango 300mg CBD,” “Chili Mango 300mg CBD,” “Kiwi 300mg CBD,” “Classic Peanut Butter,” “CBD Hibiscus Tea,” “Apple Rings Gummies,” “Watermelon Sours Gummies,” “Sour Brats Gummies,” “Gummy Bears Gummies,” “Peach Rings Gummies” and “Pineapple 300mg CBD” 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 for such uses 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
.
Unapproved New Drugs
Based on our review of
your websites, your
“
Classic Peanut Butter 300mg CBD,” “CBD Hibiscus Tea,” “Banana Chips 300mg CBD,” “Kiwi 300mg CBD,” “Pineapple 300mg CBD,” “Mango 300mg CBD,” “Mango Chili 300mg CBD,” “Apple Rings Gummies,” “Watermelon Sours Gummies,” “Sour Brats Gummies,” “Peach Rings Gummies,” “Gummy Bears Gummies,” “Pain Roll – Pain Oil,” “CBD Sleep Tincture,” “Meraki Intense Pain Balm/Lidocaine,” “Meraki Lotion,” “Meraki Lip Balm,” “Meraki Pain Salve,” “Natrual Tincture” and “CBD 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 and/or intended to affect the structure or any function of the body.
Examples of claims observed on your website
www.plantorganix.com
that establish the intended use of your products as drugs include, but may not be limited to, the following:
On the webpage titled “What is a salve?:
“Salves’ medicinal benefits range from pain management due to inflammation, chronic skin conditions such as psoriasis and eczema as well as localized pain or sores within joints or on the skin . . ”
On the product pages for “Banana Chips 300mg CBD,” “Pineapple 300mg CBD,” “Kiwi 300mg CBD,” “Mango 300mg CBD,” “Chili Mango 300mg CBD”:
“[R]educing the side effects of: anxiety, depression, pain, inflammation … adhd, immune disorders.”
On the product pages for “Watermelon Sours Gummies,” “Gummy Bears Gummies,” “Apple Rings Gummies”:
“[E]ase the symptoms of: … anxiety, depression, pain, inflammation, auto immune disorders, adhd, chrones [
sic
] disease…”
On the product page for “Meraki Intense Pain Balm/Lidocaine”:
“This intense pain balm is used for extreme pain and inflammation.”
“Made to ease the symptoms from: arthritis, osteoporosis, joint pain, sciatica, muscle tension, back pain, neck pain, inflammation, nerve damage…”
On the product page for “Meraki Lotion”:
“[M]eraki lotions is great for pain relief and skin healing as a whole. Reduced inflammation, Psoriasis, eczema...”
On the product page for “Pain Roll – Pain Oil”:
“Pain oil- these are used for on the go treatment on inflammation, headaches, neck tension, arthritis, gout, and most skin ailments.”
On the product page for “Peach Rings Gummies”:
“[H]elp reduce the symptoms of: … anxiety, depression, pain, inflammation…”
On the product page for “MCT Oil Tincture”:
“Could Help Manage . . . Alzheimer's Disease and Autism. ... Contains Powerful Fatty Acids That Fight Yeast and Bacterial Growth.”
“Used for reducing symptoms of: … depression, anxiety, most metal health uses”
On the product page for “Meraki Lip Balm”:
“Anti bacterial and anti microbial.”
On the product pages for
“Meraki Pain Salve”:
Name of products: “Pain Salve”
On the product page for “
CBD Hibiscus Tea”:
“Used to reduce the symptoms of: … anxiety, headaches, cold, flu, insomnia … adhd, Alzheimer's, and dementia”
On the product page for “
Sour Brats Gummies”:
“They help with … anxiety, depression, adhd, autism …”
On the product page for “
CBD Sleep Tincture”:
“Helps you manage Pain … anxiety, inflammation, neuropothy [
sic
], depression . . . mental and brain disorders, helps regulate insuline [
sic
] production, blood pressure, and many other problems ...”
On the product page for “Natrual Tincture”:
“It can be used to reduce the symptoms of . . . anxiety, depression, adhd, metal [
sic
] disorders, auto-immune disorders, sleep, headaches, migraines”
Additional claims observed on
your social media sites
www.facebook.com/plantorganixwellness
and
www.instagram.com/plantorganix_edu
include, but are not limited to, the following:
On your Facebook Social Media Account:
April 10, 2019 posting – “Vaping CBD oil is one of the preferred methods to ease side effects of diseases, illnesses, and ailments including Leukemia, all types of Cancers … anxiety, joint pain . . . inflammation, sleep apnea, high blood pressure and the list goes on.”
February 11, 2019 posting – “CBD oil has also shown to aid in health issues such as anxiety, depression, acne and heart disease. For those with cancer, it may even provide a natural alternative for pain and symptom relief.”
August 29, 2018 posting – “Here are just five of the key health benefits of CBD oils: Pain relief. One of the most celebrated health benefits of CBD oil is its analgesic (pain relieving) effects . . . Combat Anxiety . . . Fight Cancer . . . Reduce the Risk of Diabetes.”
On your Instagram Social Media Account:
August 23, 2019 posting – “Stress and Chronic pain can be a huge cause of depression. When you are suffering from these things the brain produces a protein that blocks the production of serotonin and dopamine. Daily ingestion of CBD can dispel that protein and allow the brain to release serotonin and dopamine (the happy chemicals) naturally. Thus, providing relief from depression.”
August 16, 2019 posting – “CBD make [
sic
] sure the brain functions properly, it helps memory, depression . . . reduces inflammation.”
Your “Classic Peanut Butter 300mg CBD,” “CBD Hibiscus Tea,” “Banana Chips 300mg CBD,” “Kiwi 300mg CBD,” “Pineapple 300mg CBD,” “Mango 300mg CBD,” “Chili Mango 300mg CBD,” “Apple Rings Gummies,” “Watermelon Sours Gummies,” “Sour Brats Gummies,” “Peach Rings Gummies,” “Gummy Bears Gummies,” “Pain Roll – Pain Oil,” “CBD Sleep Tincture,” “Meraki Intense Pain Balm/Lidocaine,” “
Meraki Lotion,” “Meraki Lip Balm,” “Meraki Pain Salve,” “Natrual Tincture” and “CBD Tincture” 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 “
Classic Peanut Butter 300mg CBD,” “CBD Hibiscus Tea,” “Banana Chips 300mg CBD,” “Kiwi 300mg CBD,” “Pineapple 300mg CBD,” “Mango 300mg CBD,” “Chili Mango 300mg CBD,” “Apple Rings Gummies,” “Watermelon Sours Gummies,” “Sour Brats Gummies,” “Peach Rings Gummies,” “Gummy Bears Gummies,” “Pain Roll – Pain Oil,” “CBD Sleep Tincture,” “Meraki Intense Pain Balm/Lidocaine,” “Meraki Lotion,” “Meraki Lip Balm,” “Meraki Pain Salve,” “Natrual Tincture” and “CBD Tincture” 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, 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).
Prohibited Act Under 301(ll) and Adulterated Foods
Furthermore, 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.
[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 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 “Banana Chips 300mg CBD,” “Mango 300mg CBD,” “Chili Mango 300mg CBD,” “Classic Peanut Butter,” “CBD Hibiscus Tea,” “Apple Rings Gummies,” “Watermelon Sours Gummies,” “Sour Brats Gummies,” “Kiwi 300mg CBD,” “Pineapple 300mg CBD,” “Gummy Bears Gummies,” and “Peach Rings Gummies” 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.
[2]
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 “Banana Chips 300mg CBD,” “Mango 300mg CBD,” “Chili Mango 300mg CBD,” “Kiwi 300mg CBD,” “Pineapple 300mg CBD,” “Classic Peanut Butter,” “CBD Hibiscus Tea,” “Apple Rings Gummies,” “Watermelon Sours Gummies,” “Sour Brats Gummies,” “Gummy Bears Gummies,” and “Peach Rings Gummies” 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 website,
www.plantorganix.com
,
FDA determined that your firm is marketing the unapproved new animal drugs “Hemp Pet Tinctures” and “Hemp Pet Treats.”  Based on our review of your website, your “Hemp Pet Tinctures” and “Hemp Pet Treats” 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 website:
www.plantorganix.com
that show the intended uses of these products include, but are not limited to, the following:
On the webpage titled “CBD for Pets”:
“Here are a few (not all) health bene
fi
ts your four-legged family member can overcome with the use of CBD:
1. Pain Reliever
CBD interacts with the receptors in the brain ultimately improving the pain management system.
2. Anticonvulsant
The FDA has of
fi
cially approved the
fi
rst cannabis-drug to reduce seizures. CBD is known for controlling seizures, tremors, tics and spasms without causing liver damage as most prescribed medications will do for pets.
3. Anti-In
fl
ammatory
Studies show that CBD decreases chronic inflammation.
…
6. Anticancer Effects
Slowing tumor growth, protecting against certain cancers and killing cancerous cells, this herb is quite literally a life saver.
7. Promotes Homeostasis
Safe to use as an everyday tincture, this supplement will promote wellness and overall health just as a daily vitamin would.”
On your product webpage for “Hemp Pet Tinctures (250 mg, 500 mg, 750 mg, and 1000 mg)”
“This is a Holistic Botanical oil blend that can aid your pet in reducing their stress, separation anxiety, pain, inflammation, healthy life, cancer, and oral health.”
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.
[3]
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.
Under section 409 of the FD&C Act, an animal 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 animal food. Animal 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.  Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
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 and 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.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or
by email to
FDAADVISORY@fda.hhs.gov
.
Sincerely,
/S/
D
onald D. Ashley
Director
O
ffice of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
/S/
William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
/S/
Eric Nelson
Director of Compliance
O
ffice of Surveillance and Compliance
Center for Veterinary Medicine
Food and Drug Administration
[1]
CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex.  (See
Sativex Commences US Phase II/III Clinical Trial in Cancer Pain
and
GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome
). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.  Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
[2]
Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food, (2) pesticide chemicals, (3) color additives, (4) substances used in accordance with 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), (5) new animal drugs, and (6) dietary ingredients in or intended for use in a dietary supplement.
[3]
Under section 201(s)(5) of the FD&C Act (21 U.S.C. 321(s)(5)), new animal drugs are excluded from the food additive definition. If a new animal drug is unsafe within the meaning of section 512 because it is not approved for use in animal food, then the animal food is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.
Content current as of:
11/25/2019
Regulated Product(s)
Food & Beverages