Warning Letter...
Warning Letter...
— AJ (@Rooofer) October 31, 2024
Richardson Nutritional Center, LLC/Nutriseeds, Inc. - 610544 - 02/19/2021 https://t.co/ADsGli1lbr
WARNING LETTER
Richardson Nutritional Center, LLC/Nutriseeds, Inc.MARCS-CMS 610544 —
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750 South Main StreetLakeport, CA 95453United States
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United States
WARNING LETTER
WL 610544
Dear Mr. Richardson:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.nutriseeds.com in January 2021 and has determined that you take orders there for your Nutriseeds Fresh Bitter Apricot Seeds (8 oz, 16 oz, and 32 oz), Nutriseeds Natural Amygdalin Extract (100 mg and 500 mg capsules), and Nutriseeds Natural B15 – Pangamic Acid (500 mg capsules) products. FDA also reviewed your “eBook,” Apricot Seeds and B17: What You Need to Know, which is available upon request at www.nutriseeds.com, and your website www.californiaapricotseeds.com; both the Apricot Seeds and B17: What You Need to Know “eBook” and www.californiaapricotseeds.com direct consumers to your website www.nutriseeds.com to purchase your Nutriseeds products.
In addition, FDA reviewed your website at the Internet address www.rncstore.com and has determined that you take orders there for your RNC Bitter Raw Apricot Seeds (8 oz, 16 oz, and 32 oz) and RNC Laetrile B17 (100 mg and 500 mg capsules) products. FDA also reviewed your RichardsonNutritionalCenter YouTube channel at https://www.youtube.com/channel/UCaX_tX910g6RJVbBOgUIi-Q/featured, which directs consumers to your website www.rncstore.com to purchase your RNC products.
The claims on your websites, your Apricot Seeds and B17: What You Need to Know “eBook”, and your YouTube channel establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the claims that provide evidence that your products are intended for use as drugs include the following:
Regarding your Nutriseeds Fresh Bitter Apricot Seeds and Nutriseeds Natural Amygdalin Extract products:
On your website www.californiaapricotseeds.com:
• “Studies have shown that B17 may help boost immunity by slowing down the spread of illness throughout the body by killing harmful cells ….”
This website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
• “I bought these for their anti-cancer properties . . . .”
• “Been eating these occasionally, putting a few seeds in shakes. I have a cyst the size of a golf ball and occasionally have excruciating pain during my cycle but I haven’t been getting them. Works for me!”
In your “eBook,” Apricot Seeds and B17: What You Need to Know:
• “[T]he Chinese discovered medicinal purposes for the bitter seeds that are found inside the pit. They use bitter apricot seeds . . . to treat asthma, coughs, dry lungs, sinus discharge and constipation.”
• “It’s no wonder the Chinese use them to resolve ‘gut disorders’. Those who eat apricot seeds on a regular basis find themselves having no problems with constipation.”
• “Apricot kernels . . . They’re also loaded with healthy fats that may help to lower “bad” cholesterol . . . These may help fight heart disease . . . . ”
Regarding your RNC Bitter Raw Apricot Seeds products:
On your website www.rncstore.com:
• “Our natural Bitter Apricot Seeds have high levels of B17(amygdalin) in them. Vitamin B17 works in the control of cancer, with doctors. . . using it to treat patients with remarkable effects...”
On your YouTube RichardsonNutritionalCenter channel, in the video, Amygdalin & The Power of Apricot Seeds, accessible at https://www.youtube.com/watch?v=J3dCZGGsmqg:
• At 9:05: "Benefits of apricot seeds…
o Neuropathic health practitioners often use apricot seeds for a variety of health issues such as bronchitis because it helps with oxygenating the blood, asthma, emphysema, coughing and wheezing . . .
o May reduce respiratory issues such as bronchitis, asthma, emphysema, coughing & wheezing…
o May strengthen ability to resist infections like colds & flu…
o May relieve arthritis pain…
o May lower blood pressure…”
Regarding your RNC Laetrile B17 products:
On your website www.rncstore.com:
• “Laetrile B17 Supplements & Treatment . . . Laetrile has been used as an anti cancer agent since the 1800’s…”
On your YouTube account for Richardson Nutritional Center in the video, Amygdalin & The Power of Apricot Seeds, accessible at https://www.youtube.com/watch?v=J3dCZGGsmqg:
• At 23:30: “[H]is cancer is in remission, because of it, because of laetrile…”
Regarding your Nutriseeds Natural B15 – Pangamic Acid product:
On your website, www.californiaapricotseeds.com:
• “Pangamic Acid supplementation can reduce the buildup of lactic acid . . . Hum, do you think this vitamin might assist with Fibromyalgia?”
In your “eBook,” Apricot Seeds and B17: What You Need to Know:
• “Pangamic acid is used for . . . treating asthma and related diseases, skin conditions including eczema, lung problems, painful nerve and joint conditions, cancer, and arthritis . . . .”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the 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 the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “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. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your Nutriseeds Fresh Bitter Apricot Seeds, Nutriseeds Natural Amygdalin Extract, Nutriseeds Natural B15 – Pangamic Acid, RNC Bitter Raw Apricot Seeds, and RNC Laetrile B17 products 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. Accordingly, your Nutriseeds Fresh Bitter Apricot Seeds, Nutriseeds Natural Amygdalin Extract, Nutriseeds Natural B15 – Pangamic Acid, RNC Bitter Raw Apricot Seeds, and RNC Laetrile B17 products fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the 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 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 address 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 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 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 response should be directed to:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
Refer to the Unique Identification Number CMS 610544 when replying.
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations-West Division 5
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