WARNING LETTER
Proper Nutrition Inc.
MARCS-CMS 612435 —
April 20, 2021
Delivery Method:
UPS
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Dr. Leonard C. Giunta
Recipient Title
President
Proper Nutrition Inc.
439 S. Bolmar Street
West Chester
,
PA
19382-4933
United States
Issuing Office:
Human and Animal Food Division II East
United States
WARNING LETTER
CMS #612435
April 20, 2021
Dear Dr. Giunta:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.propernutrition.com in April 2021 and has determined that you take orders there for the products Colostrum 70/40, Intestive, Seacure (blister pack and bottle), and SeaVive for Immune Support. The claims on your website 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 can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Examples of some of the claims observed on your website https://www.propernutrition.com that provide evidence that your products are intended for use as drugs include:
Colostrum 70/40:
https://shop.propernutrition.com/products/colostrum-70/40-90-capsule-bottle/
“. . . Colostrum 70/40® is a bovine colostrum that provides Growth Factors and Immune Factors, which are essential for . . . wound or tissue repair.”
Intestive:
https://shop.propernutrition.com/products/intestive-120-capsules-blisters-pack/
“. . . proven beneficial to wound healing”
Seacure:
https://shop.propernutrition.com/products/seacure-180-capsules-blister-pack/
https://shop.propernutrition.com/products/seacure-180-capsules-bottle/
“. . . health care practitioners report how pleased they are with Seacure®. Through their own clinical experience, they know that the bioactive peptides work directly in the gastrointestinal tract to reduce symptoms and restore gut integrity in patients with Crohn’s, IBS, malabsorption and other gut related problems.”
“. . . proven to be very beneficial in wound healing . . ..”
“. . . beneficial in treating digestive problems and wound healing and for conditions that cause a general malaise, such as AIDS, or treatments like chemotherapy.”
“. . . trigger a sequence of events that . . . reduce inflammation.”
SeaVive:
https://shop.propernutrition.com/products/
https://shop.propernutrition.com/products/seavive-90-capsules-bottle/
“. . . natural contents provide essential immunoglobulin and other powerful immune factors to kill, block and inhibit the daily threat from viruses and harmful bacteria, particularly in the digestive tract and lungs.”
“. . . supplies immune factors to the intestinal lining to ward off infection . . .”
On “The Science” page, under “Relief for Digestive Disorders”:
https://www.propernutrition.com/the-science/relief-for-digestive-disorders/
“Proper Nutrition’s dietary supplements bring relief to patients suffering from a range of digestive disorders, including:
o Irritable Bowel Syndrome – Also known as IBS, this intestinal disorder occurs in the colon and small intestine . . .
o Colitis – A chronic illness in which the lining of the colon becomes inflamed and develops ulcers.
o Leaky Gut Syndrome – This condition is . . . often associated with diseases such as Crohn’s or Celiac. It occurs when the junctions between your intestines malfunction and allow unwanted – and potentially toxic – material into your blood steam [sic].
The bioactive peptides found in products such as Seacure® and Seavive® work directly in your gastrointestinal tract to reduce the symptoms of digestive disorders …. These peptides have also shown to be beneficial in wound healing”
On “The Science” page, under “Overview”:
https://www.propernutrition.com/the-science/overview/
“SeaVive helps correct pathogenic bowel permeability and prevents hazards from passing through the gut membrane to infect internal organs.”
“Boswellia [an ingredient in Intestive] is a plant used for centuries … as an anti-inflammatory and anti-irritant.”
“Colostrum 70/40® contains valuable immune factors that form antibodies to protect against infection. It also provides grown and immune factors, which are essential for … repairing wounds and tissue injuries.”
Your Colostrum 70/40, Intestive, Seacure (blister pack and bottle), and SeaVive for Immune Support supplement 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 FDA, as described in sections 301(d) and 505(a) of the 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.
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 CFR 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 Seacure (blister pack and bottle) and SeaVive for Immune Support supplement 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 Seacure (blister pack and bottle) and SeaVive supplement products fail to bear adequate directions for their intended use 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)].
This letter is 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 6000 Metro Drive, Suite #101, Baltimore, Maryland 21215. If you should have any questions regarding any issue in this letter, please contact Robin M. Rivers, Compliance Officer, at (215) 717-3076 or by e-mail robin.rivers@FDA.HHS.GOV. Files greater than 100 megabytes may be submitted as smaller files in separate emails.
Sincerely,
/S/
Randy F. Pack
District Director, Baltimore Office
Program Division Director
Human and Animal Food Division II East
Content current as of:
04/27/2021
Regulated Product(s)
Drugs
Food & Beverages