The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 750 Farroll Rd, Unit H, Grover Beach, CA 93433 on April 2 and April 4, 2018. During the inspection, we collected labels for your products. Based on the inspectional findings, a subsequent review of the product labels collected during the inspection, and a subsequent review of your websites at the Internet addresses http://lifelinknet.com/siteResources/default.asp and http://www.ilifelink.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at
http://www.fda.gov
.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your websites at the Internet addresses http://lifelinknet.com/siteResources/default.asp and http://www.ilifelink.com in August 2018 and has determined that you take orders there for the products 5-HTP, MonoDEA (micronized DHEA), DendroMax, Potassium Orotate, Pregnenolone, GABA Gamma-Aminobutyric Acid, and Monolith. In addition, FDA reviewed your product labels following an inspection of your facility at 750 Farroll Rd, Unit H, Grover Beach, CA 93433 on April 2 and April 4, 2018. The claims on your website and product labels establish that the 5-HTP, MonoDEA, DendroMax, Potassium Orotate, Pregnenolone, GABA Gamma-Aminobutyric Acid, and Monolith 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. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims and claims on your product label that provide evidence that your products are intended for use as drugs include:
5-HTP (available in capsule or lozenge form
)
On the product label:
- “5-HTP . . . is the immediate precursor of serotonin. Low levels of serotonin are associated with depression, obesity and sleep disorders.”
On the webpage http://www.lifelinknet.com/siteResources/Products/HTP.asp:
- “KEYWORDS: … depression, insomnia, obesity … fibromyalgia, migraine…”
On the webpages http://www.lifelinknet.com/siteResources/Products/HTP.asp and http://www.ilifelink.com/5-htp_5-hydroxy-l-tryptophan_100_mg_x_30_caps.html:
- “Overview … Medical studies have so far identified the following applications for 5-HTP supplements: … headaches, including migraine …fibromyalgia …panic attacks, delirium, sleep disorders … depression, excessive eating.”
- “5-HTP and depression . . . clinical studies and very large numbers of anecdotal reports attest to the effectiveness of 5-HTP as an antidepressant . . . .”
- “5-HTP and sleep disorders . . . it was studied as a treatment for insomnia. Despite the encouraging results of early studies, and countless positive anecdotal reports over the years, medical research has almost completely ignored it as an insomnia treatment.”
- “5-HTP and fibromyalgia . . . [c]linical trials in fibromyalgia patients in the early 1990s demonstrated significantly lessened symptoms.”
- “5-HTP and migraine . . . almost a dozen clinical trials have been conducted – most of them showing some efficacy of 5-HTP for prevention of migraines and other headaches.”
- “5-HTP and panic attacks. In a 2004 study, panic disorder patients . . . who had been pretreated with 200 mg of 5-HTP and significantly reduced panic symptoms . . ..”
MonoDEA (micronized DHEA)
On the webpage http://www.lifelinknet.com/siteResources/Products/MonoDEA.asp:
- “KEYWORDS: …cancer … cardiovascular disease … osteoporosis, diabetes…”
- “Overview … Studies of DHEA have found evidence to support such uses as: … controlling … obesity, reducing lipodystrophy (fat redistribution) caused by HIV drugs … lowering reducing cholesterol levels and the incidence of atherosclerosis … inhibiting cancers of the breast, prostate, colon, liver, and skin … reducing joint pain … preventing venous ulceration, accelerating wound-healing … improving cognition in HIV patients, reducing depression … reducing incidence of lupus flares….”
- “Studies in humans and other mammals suggest other possible uses for DHEA: … reducing incidence and severity of multiple sclerosis, inhibiting progression or reducing symptoms of Parkinson’s, ameliorating allergies such as atopic dermatitis and allergy-induced asthma, preventing herpes virus type 2 encephalitis, preventing diabetes, and increasing insulin sensitivity in diabetics….”
DendroMax
On the webpage http://www.lifelinknet.com/siteResources/Products/DendroMax.asp:
- “KEYWORDS: … Multiple sclerosis, rheumatoid arthritis, lupus, diabetes, IBS, Crohn’s…”
- “Overview … Connections have recently been found between glycan defects and the following autoimmune diseases: Multiple sclerosis, Inflammatory bowel disease, Diabetes — both Type 1 and 2, Lupus Erythematosus, Rheumatoid arthritis, Autoimmune hemolytic anemia, Tn syndrome, Autoimmune kidney disease…”
- “The researchers at UC Irvine have also shown that higher-than-normal levels of N-acetyl-glucosamine can correct one category of glycan defect. In a recent report, they state that NAG “may provide an inexpensive and non-toxic oral therapeutic agent for MS [Multiple Sclerosis] that directly targets an underlying molecular mechanism causal of disease.’”
Potassium Orotate
On the webpage http://www.lifelinknet.com/siteResources/Products/Orotate-potassium.asp:
- “KEYWORDS: … hepatitis, dental cavities, dizziness … anxiety … depression, wound healing, tissue repair…”
- “Overview … Potassium Orotate - a supplement with a talent for reversing tissue damage throughout the body, including the brain. … Potassium orotate supplementation has been found to have a variety of applications in such areas as: heart, liver, kidney, and lung damage, wound healing and skin ailments, viral hepatitis, … tuberculosis, diabetes, epilepsy, anxiety, depression, dizziness, and disorientation, bone fractures, dental cavities….”
Pregnenolone
On the webpage http://www.lifelinknet.com/siteResources/Products/Pregnenolone.asp:
- “KEYWORDS: … depression, bipolar … arthritis, schizophrenia, dementia…”
On the webpages http://www.lifelinknet.com/siteResources/Products/Pregnenolone.asp and http://www.ilifelink.com/pregnenolone_30_mg_x_50_capsules.html?sea:
- “Overview … Pregnenolone has a long history of use as a drug .... It has been shown to have a wide range of beneficial actions for people who are sick or under stress. These include: ameliorating arthritis (300 mg/day)…”
- “Many scientific studies provide evidence that pregnenolone can … lessen depression, control ‘bipolar disorder’, reduce schizophrenic symptoms…”
- “Anxiety…Studies in patients with anxiety disorders have shown that higher anxiety levels correlate with lower pregnenolone levels in the blood...”
GABA Gamma-Aminobutyric Acid
On the webpage http://www.lifelinknet.com/siteResources/Products/GABA.asp:
- “KEYWORDS: … insomnia…”
- “GABA supplementation has been shown to be effective for: …reducing high blood pressure…”
- “In addition, the following actions are suggested by indirect scientific evidence: improve schizophrenic symptoms …”
- “And then there are the GABA usages that have never been properly investigated scientifically. For these we have to rely on anecdotal evidence: …diminishing arthritis pain and lower back pain…reducing symptoms of alcohol withdrawal…controlling hypoglycemia…alleviating some types of depression…”
Monolith
On the webpage http://www.lifelinknet.com/siteResources/Products/Monolith.asp:
- “KEYWORDS: Alzheimer’s, Parkinson’s, ALS, neurodegenerative, alcoholism, bipolar, manic-depression”
- “Monolith: A source of lithium . . .. Other lithium salts have been used for more than a century to treat mania. During the past few decades lithium therapy has become one of the mainstays in the treatment of ‘bipolar disorder’ (manic-depression). A number of lab studies have kindled interest in the use of lithium for treating Alzheimer’s and other neurodegenerative diseases.”
- “Recent work in the clinic and laboratory suggests the following applications for lithium orotate: …neurodegenerative diseases: Alzheimer’s, Huntington’s, ALS, Parkinson’s, and others...preventing episodic impulsive aggressiveness…protecting the brain from damage by alcohol…treating kleptomania…preventing symptoms of Fragile X Syndrome…”
- “Furthermore, orotates (even those without lithium) have other useful properties: protecting the heart from arrhythmias…reducing heart-attack damage…eliminating nerve-damaging deposits of lipofuscin and ceroid pigments.”
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)(1) of the Act [21 U.S.C. § 321(p)(1)]. 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 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 5-HTP, MonoDEA, DendroMax, Potassium Orotate, Pregnenolone, GABA Gamma-Aminobutyric Acid, and Monolith products are intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention 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 5-HTP, MonoDEA, DendroMax, Potassium Orotate, Pregnenolone, GABA Gamma-Aminobutyric Acid, and Monolith 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
During the April 2 and 4, 2018, inspection, our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your dietary supplement products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Additionally, even if your 5-HTP (capsules form), MonoDEA, DendroMax, Potassium Orotate, GABA Gamma-Aminobutyric Acid, and Monolith products did not have therapeutic claims which make them unapproved new drugs and misbranded drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
We did not receive a written response from you regarding our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on April 4, 2018.
We understand that you contract with other manufacturers to perform certain operations relating to products that are distributed into interstate commerce under your firm’s name. Specifically, we understand that your firm receives components at your facility that you ship to third parties to manufacture your finished products. These finished products are then shipped back to your firm to distribute into interstate commerce under your firm’s name. As a distributor that contracts with another manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce in its final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements.
[2]
The Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and/or labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
The significant violations documented during the inspection include, but are not limited to, the following:
1. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. Specifically, you have not implemented any written quality control procedures.
To fulfill requirements for quality control operations, quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Your quality control unit must approve for release or reject any packaged and labeled dietary supplement for distribution (21 CFR 111.127(h)), and you must make and keep written documentation, at the time of performance, that the quality control personnel performed the review, approval, or rejection requirements (111.140(b)(2)).
2. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you have no written procedures for the review and investigation of product complaints. Once you establish the necessary written procedures, you must make and keep written records of product complaints, in accordance with 21 CFR 111.570.
3. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distributing operations. Once you establish such written procedures, you must make and keep records of holding and distributing operations, in accordance with 21 CFR 111.475.
4. You failed to establish and follow written procedures for fulfilling the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures for returned dietary supplements. Once you establish such written procedures, you must make and keep records for returned dietary supplements, as required by 21 CFR 111.535.
Misbranded Dietary Supplements
Certain of your dietary supplement products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101, for the reasons discussed below. Additionally, even if your MonoDEA, DendroMax, Potassium Orotate, GABA Gamma-Aminobutyric Acid, and Monolith products did not have therapeutic claims which make them unapproved new drugs, your products would be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] because they also do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101, as follows:
1. Your DendroMax and GABA Gamma-Aminobutyric Acid products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each of the product labels fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, the terms N-acetyl glucosamine and Gamma-Aminobutyric Acid, rather than NAG and GABA, respectively, must be placed in the Supplement Facts label for each product.
2. Your DendroMax and MonoDEA products are each misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on each label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b). An incorrect serving size could cause a consumer to overconsume the product. For example:
- Your DendroMax product label’s suggested use indicates 1—4 tablets per day, but the serving size lists one (1) tablet. The serving size listed should be four (4) tablets;
- Your Mono(DEA) product label’s suggested use is “1 to 2 capsules in the morning”, but the serving size lists “1 capsule”. The declared serving size should be two (2) capsules.
3. Your DendroMax product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutritional information on the labeling of your product does not comply with 21 CFR Part 101.36. For example:
- Your DendroMax product label fails to correctly declare the %DV for the (b)(2)-dietary ingredient Vitamin D3, in accordance with 21 CFR 101.36(b)(2)(iii);
- Your DendroMax product label fails to declare the source ingredient for the Vitamin D3, in accordance with 21 CFR 101.36(d);
- Your DendroMax product label’s Supplement Facts label fails to list the Vitamin D3 ((b)(2)-dietary ingredient) before the N-acetyl-glucosamine ((b)-3 dietary ingredient), per 21 CFR 101.36(b)(3)(i).
- Your Potassium Orotate product label incorrectly declares “Daily Value not established” for potassium. The percent of the Daily Value of all dietary ingredients for which FDA has established Daily Values must be declared in accordance with 21 CFR 111.36(b)(2)(iii) and21 CFR 101.9(c)(8)(iv);
- Your Omega-3 Fish Oil with EPA and DHA product label declares an incorrect %DV per serving for the declared quantitative amounts of saturated fat and cholesterol in accordance with 21 CFR 101.36(b)(2)(iii)(B) and 21 CFR 101.9(c);
- Your Omega-3 Fish Oil with EPA and DHA product label declares trans fat. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 21 CFR 101.9(c), shall not be declared. [21 CFR 101.36(b)(2)(i)].
4. Your DendroMax and Omega-3 Fish Oil with EPA and DHA products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product labels fail to declare the specific species of shellfish and fish allergen sources as required by section 403(w) of the Act.
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)]; or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
Specifically, your DendroMax and Omega-3 Fish Oil with EPA and DHA product labels do not declare the specific type of shellfish or fish present in each product, respectively. A declaration of the “species” of fish or Crustacean shellfish for purposes of complying with Section 403(w)(2) of the Act [21 U.S.C. § 343(w)(2)] should be made using the acceptable market name provided in FDA's The Seafood List. We note, however, that if a “Contains” statement is used to declare the source of the fish or Crustacean shellfish, we would not object to just the type of fish or Crustacean shellfish being used, e.g., “Contains salmon” or “Contains trout.”
Furthermore, we note that your DendroMax product label includes the statement “Food allergy warning: Contains shellfish products” which is not the appropriate language to declare a major food allergen as defined by section 201(qq) of the Act (21 U.S.C. § 321 (qq)). Major food allergens should be declared using the word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients or the common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen).
5. Your DHEA, MonoDEA, DendroMax, Potassium Orotate, Monolith, and GABA Gamma-Aminobutyric Acid products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
Registration of Food Facilities
We have determined that your facility located at 750 Farroll Rd, Unit H, Grover Beach, CA 93433 is subject to the registration requirement in Section 415 of the Act [21 U.S.C. § 350d] and our implementing regulations at 21 CFR Part 1, Subpart H. During the inspection of your facility, you were advised of this requirement. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act [21 U.S.C. § 331(dd)]. (b)(4).
As a responsible official of a facility that manufactures/processes, packs, re-labels or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
(b)(4). Registration may be accomplished on-line at
http://www.access.fda.gov
. We strongly encourage the use of electronic registration because it provides automatic confirmation of registration and automatic issuance of a registration number.
(b)(4). This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575- 0156, or by writing to the Agency at the following address:
U.S. Food and Drug Administration, HFS-681 Food Facility registration (HFS-681)
5001 Campus Drive
College Park, MD 20740
When completed, the form may be faxed to (301) 436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility’s registration number using the same method used to submit the registration to FDA.
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 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, including FDA regulations.
You should take prompt action to correct the violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover the FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, the FDA may assess fees to cover any reinspection-related costs.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 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.
