- Delivery Method:
- VIA UPS
Recipient NameAndrew Frisella
- 1st Phorm LLC
2091 Fenton Logistics Park Blvd
Fenton, MO 63026
- Issuing Office:
- Office of Human and Animal Food West Division II
July 29, 2021
Reference CMS #: 613715
Dear Mr. Frisella,
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.1stphorm.com in March 2021. Based on our review of your website, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. As explained further below, introducing or delivering the products discussed below for introduction into interstate commerce violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drugs / Misbranded Drugs
FDA reviewed your website at the Internet address www.1stphorm.com in March 2021 and has determined that you take orders there for your products Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of 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.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
On your product webpage for Whole Heart Cardiovascular Health Formula, the following statements were found on the product description page https://1stphorm.com/collections/heart-health/products/whole-heart.
- “Whole Heart is a pharmaceutical-grade blend of ingredients designed to . . . combat cardiovascular disease and heart attacks.”
- “[The natural substances in Whole Heart are also key components in helping treat arthritis and other common issues like acne and skin-diseases.”
- “We formulated Whole Heart to help decrease unhealthy levels of LDL cholesterol.”
- ” Regular use ofWhole Heart can revamp your body’s blood flow and help decrease cholesterol production.”
- “Narrowing of the arteries increases resistance can lead to high blood pressure, the silent killer. To help remedy this, the ingredients in Whole Heart were carefully chosen because of their ability to lower inflammation and prevent the breakdown of nitric oxide, which can result in decreased blood pressure levels.”
- [product label image] “IMPROVE LDL/HDL Ratio”
On your product webpage for Full-Mega Omega-3 Fish Oil, the following statements were found on the product description page https://1stphorm.com/collections/heart-health/products/full-mega.
- “Studies on fish oils rich in both EPA and DHA have shown they help with lowering blood pressure, reducing triglyceride levels, lowering “bad” cholesterol (LDL) levels . . ..”
- “The results of clinical studies have shown that they can be used to treat symptoms of ADHD as well as to combat symptoms of depression.”
- “Omega-3 fish oils rich in EPA and DHA have been shown to improve your body’s natural anti-inflammatory response. They can also be used to reverse the symptoms of many conditions that are triggered by inflammation, such as asthma and psoriasis. Help boost your body’s natural anti-inflammatory response . . . by supplementing daily with Full-Mega.”
- [product label image] “REDUCE Inflammation” and “MODERATE Cholesterol Levels”
Your Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil 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 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), 355(a)]. A new drug is approved by the FDA based on 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 Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil 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, Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil 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)].
Adulterated Dietary Supplements
Your MegaWatt V2, Thyro-Drive, 1-Db Overdrive Fastpack, 1-Db Goddess, and 1-Db Overdrive & Thyro-Drive products are adulterated within the meaning of section 413(a) of the Act [21 U.S.C. § 350b(a)]. The Supplement Facts labels for each of these products declares hordenine as a dietary ingredient. Hordenine is a “dietary ingredient” under section 201(ff)(1)(B) of the Act [21 U.S.C. § 321(ff)(1)(B)] and a “new dietary ingredient” (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) under section 413(d) of the Act [21 U.S.C. § 350b(d)].
Under section 413(a) of the Act [21 U.S.C. § 350b(a)], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:
1. The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
To the best of FDA’s knowledge, there is no information demonstrating that hordenine was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. As such, hordenine is subject to the notification requirement in section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6. Products for which the manufacturer or distributor is required to submit a new dietary ingredient notification under section 413(a)(2) and 21 CFR 190.6, but for which the required notification has not been submitted, are adulterated under sections 402(f) and 413(a) of the Act [21 U.S.C. §§ 342(f) and 350b(a)]. Introduction of such products into interstate commerce is prohibited under sections 301(a) and (v) of the Act [21 U.S.C. § 331(a) and (v)].
Moreover, based on our evaluation of the relevant safety evidence, there is no history of use or other evidence of safety establishing that hordenine will reasonably be expected to be safe when used as a dietary ingredient. Therefore, even if a new dietary ingredient notification had been submitted, dietary supplements containing hordenine would be adulterated under sections 402(f) and 413(a) of the Act [21 U.S.C. §§ 342(f) and 350b(a)]. In the absence of adequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury, dietary supplements containing hordenine are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. § 342(f)(1)(B)].
This letter is not intended to be an all-inclusive statement of violations that may 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. 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, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Bruce E. Taylor, Compliance Officer. If you need additional information or have questions concerning any products distributed through your website, please contact CO Taylor at 913-495-5114 or at the above address or via email at: firstname.lastname@example.org.
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Food
West Division II
-Sal Frisella, President
1st Phorm LLC
- Christopher M. Klein, President/COO