WARNING LETTER
ForYou, Inc.
MARCS-CMS 607305 —
October 20, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Dietary Supplements
Recipient:
Recipient Name
Dr. Winferd D. Holt
Recipient Title
CEO/Co-Owner
ForYou, Inc.
3980 Main Street
Loris
,
SC
29569
United States
Issuing Office:
Division of Human and Animal Food Operations East III
United States
October 20, 2020
Reference: CMS Case 607305
WARNING LETTER
Dear Dr. Holt:
The U.S. Food and Drug Administration (FDA) inspected your facility in Loris, SC from February 19, 2020 to February 21, 2020. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, found at Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplements to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) §342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
Additionally, we reviewed product labels and brochures collected during our inspection, along with your firm’s website at http://foryouinc.com, which we reviewed in July 2020. Based on our review, we concluded that certain products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)], as described further in this letter.
You can find copies of the Act and pertinent regulations through links on FDA’s homepage at
www.fda.gov.
UNAPPROVED NEW DRUGS AND MISBRANDED DRUGS
FDA reviewed your product labels and brochures for your Advanced Formula BioAnti-Oxidant, Advanced BioEnzymes, Ancient Sea Mineral Complex, Calcium pHactor, Colostrum, Honey Bee Pollen, Inner Cellular Energy Multi-Vitamin, J-genics, Thin-Ergy A.M., Thin-Ergy BOOST, Tree of Life Olive Leaf Extract, and Youth Factor with DHEA products, and FDA reviewed your website at the Internet address http://foryouinc.com, where you take orders for your products. The claims on your product labels, brochures, and 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. 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 claims that provide evidence that your products are intended for use as drugs include:
Advanced Formula BioAnti-Oxidant, Ancient Sea Mineral Complex, Colostrum Life’s First Food, Honey Bee Pollen, Inner Cellular Energy Multi-Vitamin, Tree of Life Olive Leaf Extract
Website: “Nutritional Support: Arthritis, Pain, Gout, Fibromyalgia”
Advanced Formula BioAnti-Oxidant
Website:
“Antioxidants are intimately involved in the prevention of cellular damage--the common pathway for cancer . . . and a variety of diseases. ForYou’s Advanced BioAnti-Oxidant--a very potent antioxidant!”
“Great support for: Arthritis, Blood Pressure, Cholesterol, Diabetes…Fibromyalgia, Gout, Hypertension and Circulation, Pain . . . Prostate Problems”
Advanced BioEnzymes
Brochure:
“Conditions reported to have been helped with enzymes: . . . Arthritis Relief . . . Decreased Obesity . . . Reduced Blood Pressure . . . Lessened Hardening of Arteries . . . Lowered High Cholesterol . . . Helped With Diabetes”
“Take control of ACID REFLUX”
“Due to undigested food, acid reflux has become an epidemic in our society today . . .”
“Today, colon cancer has become the number two killer. You must properly digest your food. Nothing digests food but enzymes. You must get to the root of the problem by providing adequate enzymes to digest your food . . .”
Website:
“Great Support for: Acid Reflux, Arthritis, Diabetes, Fibromyalgia, Gout, Heart-burn, Hypertension . . . Indigestion . . . Pain, Prostate Problems”
Ancient Sea Mineral Complex
Website:
“Great support for: Allergies, Arthritis, Cholesterol . . . Digestive Problems, Fibromyalgia, Gout, Hypertension, …Pain”
Calcium pHactor
Website:
“Calcium deficiency plays a role in allergy problems and has even been linked to heart disease.”
“Great Support For: Arthritis, Carpal Tunnel Syndrome, Cholesterol, High Blood Pressure, Joint Pain, and Osteoporosis”
Colostrum
Brochure:
“Success Stories in: Allergy Conditions . . . Bursitis . . . Chronic Fatigue . . . High Cholesterol. . . Colds & Flu . . . Multiple Sclerosis . . . Epstein Barr Virus . . . Hypoglycemia . . . Rheumatoid Arthritis . . . Hemorrhaging . . . Arthritis”, “Osteoporosis . . . Scleroderma . . . Tumors . . . Diabetes . . . Asthma . . . Auto-immune disorders”
“Colostrum supports a more stable, stronger defense against infection my micro-organisms, whether they are bacteria, viruses, or parasites…”
“Colostrum contains antibodies and other components that act against E-Coli 0157:H7 and 0111:NM, Salmonella, Rotavirus, Coronavirus, and is effective against most other bacteria and viruses”
“Colostrum can be used as a safe, effective alternative to steroids to block inflammation.”
Website:
“Contains all four key immunoglobulins: Igm, Igg, Iga,and secretory Iga which destroy bacteria, viruses, and yeast.
Contains antibodies that act against E. Coli, Salmonella, Rotavirus, and Coronavirus.
Contains Lactoferrin which interferes in the growth of potentially harmful bacteria.
Helps block the attachment of a wide variety of bacteria especially S. Pheumonococci to mucous membranes, helping prevent respiratory inflammations.
“Effective against most bacteria and viruses.”
“Colostrum can be used as a safe, effective alternative to steroids to block inflammation.”
“Great Support For: Allergies, Arthritis, Bone Loss, Cholesterol, Diabetes, Digestive Problems, Fibromyalgia, Gout, Hypertension . . . Pain, Prostate Problems”
Honey Bee Pollen
Website:
“Excellent for hay fever and allergies”
“Benefits . . . Allergy Relief . . . Arthritis . . . Cholesterol . . . Diabetes . . . Fibromyalgia . . . Hypertension . . .”
“Great Support For: . . . Allergies, Arthritis, Cholesterol, Diabetes . . . Fibromyalgia, Gout, Hypertension . . . Pain . . . Prostate Problems”
J-Genics
Website:
“Great Support For: . . . Insomnia, Lowering Cholesterol, Anti-Obesity, Anti-Inflammatory”
Thin-Ergy A.M.
Brochure “The Boss of Weight Loss”:
“. . . so effective that people with diabetes have noticed their bodies do not require as much insulin . . .”
Thin-Ergy BOOST
Brochure “The Boss of Weight Loss”:
“to combat today’s obesity problem”
“[the ingredient] EGCG (green tea extract) . . . has benefits in areas of cardiovascular disease and cancer. The effect of EGCG in obesity is to reduce . . . cholesterol”
“[the ingredient] banaba leaf can be a powerful weapon in the fight against high blood sugar . . .”
banaba leaf is effective in lowering blood glucose in people with regularly high blood sugar”
Tree of Life Certified Olive Leaf Extract
Brochure:
“A Natural Approach to: Common Cold . . . Viral Infections . . . Bacterial Infections . . . Arthritis . . . High Blood Pressure . . . Hardening of Arteries”
“Results have been reported on: 1) Viruses – Epstein-Barr, HIV & other viruses…2) Yeast – Candidiosis…3) Fungi…4) Parasites and worms”
Website:
“Great Support For: Arthritis, Bacterial Infections, Bursitis, Chronic Fatigue Syndrome, Common Cold . . . Enfluenza[sic] . . . Fibromyalgia, Gout, Guards against Parasites, Heart Problems, High Blood Pressure . . . Pain, Peptic Ulcers, Pneumonia, Skin Disease, and Viral Infections”
“Olive Leaf Extract is a natural form of antibiotic”
“Reports show good results on viruses, yeast (candidosis) [sic], fungi, parasites, and worms.”
“Olive Leaf Extract was virucidal against all viruses in which it was tested . . . showed an average decrease of 68% in blood pressure and showed a decline in rapid heart beat for those who started taking Olive Leaf Extract . . . a 70% improvement in his psoriasis patients who take Olive Leaf Extract.”
Youth Factor with DHEA
Brochure:
“ . . . benefits include: aids in cardiovascular problems . . . AIDS.”
Website:
“Helps alleviate . . . Chronic Fatigue Syndrome. May help arthritis and rheumatoid arthritis. Beneficial in lowering cholesterol. Aids in lowering blood pressure and helps cardiovascular problems. Enhances resistance to infection through increased antibody effects.”
Your Advanced BioEnzymes tri-fold brochure also contains evidence of intended use in the form of a personal testimonial recommending or describing the use of the product for the cure, mitigation, treatment, or prevention of disease. Specifically, the brochure bears the claim, “Before using these products I . . . suffered from acid reflux at night and constant heartburn during the day . . . Now, I am free from these.”
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 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 products Advanced Formula BioAnti-Oxidant, Advanced BioEnzymes, Ancient Sea Mineral Complex, Calcium pHactor, Colostrum, Honey Bee Pollen, Inner Cellular Energy Multi-Vitamin, J-genics, Thin-Ergy A.M., Thin-Ergy BOOST, Tree of Life Olive Leaf Extract, and Youth Factor with DHEA 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 Advanced BioAnti-Oxidants, Advanced BioEnzymes, Ancient Sea Mineral Complex, Calcium pHactor, Colostrum, Honey Bee Pollen, Inner Cellular Energy Multi-Vitamin, J-genics, Thin-Ergy AM, Thin-Ergy BOOST, Tree of Life Olive Leaf Extract, and Youth Factor w/DHEA 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 dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packaged, or held under conditions that do not meet the CGMP regulation for dietary supplements (21 CFR Part 111). Additionally, even if your Advanced Formula BioAnti-Oxidant, Advanced BioEnzymes, Ancient Sea Mineral Complex, Calcium pHactor, Colostrum, Honey Bee Pollen, Inner Cellular Energy Multi-Vitamin, J-genics, Thin-Ergy A.M., Thin-Ergy BOOST, Tree of Life Olive Leaf Extract, and Youth Factor with DHEA products did not have therapeutic claims which make them unapproved new drugs, these products would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been held under conditions that do not meet the CGMP regulation found at 21 CFR Part 111. The significant violations included 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection, your management told our investigator that you did not have any written procedures for quality control operations.
To the extent that you contract with other firms to manufacture your product that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing 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)]. Although a firm may contract out certain dietary supplement manufacturing 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. In particular, 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 out some or all of its operations must establish a system of production and process controls to 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 111.55). The 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). Further, quality control must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, and you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement [21 CFR 111.127(h) and 111.140(b)(2)].
We have reviewed your response letter, dated March 13, 2020; however, we are unable to evaluate the adequacy of your corrective actions. Your response states that you have a standard operating procedure (SOP) in place and that it has been implemented. However, you did not provide supporting documentation with your response, so we are unable to evaluate the corrections. We will evaluate that adequacy of your corrective actions at our next inspection.
2. You must establish and follow written procedures for holding and distributing operations, to comply with 21CFR Part 111.453. Specifically, your firm receives and distributes dietary supplement products, but, during the inspection, your management told our investigator that you had not established and implemented written procedures for the holding and distribution of these products.
We have reviewed your response letter, dated March 13, 2020. Your response states that you have a standard operating procedure (SOP) in place and that it has been implemented. However, we are unable to evaluate the adequacy of your corrective actions because you did not provide supporting documentation with your response. We will evaluate the adequacy of your corrective actions at our next inspection.
3. You must establish and follow written procedures to fulfill the requirements that apply to the review and investigation of product complaints, to comply with 21 CFR Part 111.553. During the inspection, our investigator determined that you have received product complaints related to your Ancient Sea Mineral Complex product. However, your management told our investigator that you had not established and implemented written procedures for the review and investigation of product complaints.
We have reviewed your response letter, dated March 13, 2020.Your response states that you have a standard operating procedure (SOP) in place and that it has been implemented. However, we are unable to evaluate the adequacy of your corrective actions because you did not provide supporting documentation with your response. We will evaluate the adequacy of your corrective actions at our next inspection.
4. You must establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements, including the procedures for the conducting a material review and making a disposition decision, to comply with 21 CFR Part 111.503. However, during the inspection, your management told our investigator that your firm has not established and followed these written procedures.
We have reviewed your response letter, dated March 13, 2020. Your response states that you will be implementing a record and/or procedures for handling returned dietary supplements. However, we are unable to evaluate the adequacy of your corrective actions because you did not provide supporting documentation with your response. We will evaluate the adequacy of your corrective actions at our next inspection.
MISBRANDED DIETARY SUPPLEMENTS
Your dietary supplement products are misbranded under section 403 of the Act [21 U.S.C. § 343]. Additionally, even if your Advanced Formula BioAnti-Oxidant, Advanced BioEnzymes, Ancient Sea Mineral Complex, Calcium pHactor, Colostrum, Honey Bee Pollen, Inner Cellular Energy Multi-Vitamin, Thin-Ergy A.M., Thin-Ergy BOOST, and Youth Factor with DHEA products did not have therapeutic claims which make them unapproved new drugs, these products would be misbranded dietary supplements within the meaning of section 403 of the Act [21 U.S.C. § 343].
1. Your Honey Bee Pollen product is misbranded with the meaning of section 403(a)(1) Act [21 U.S.C. § 343(a)(1)] in that the labeling of the product is false and misleading. Specifically, your website at the internet address www.foryouinc.com, where you take orders for your products, makes the statement “Honey Bee Pollen contains all the vitamins, minerals, trace minerals, essential proteins (25% pure protein), amino acids, enzymes, co-enzymes, and hormones known to man . . . Contains 34% amino acid protein.” However, according to the product’s Supplement Facts Label, the product does not contain all the vitamins, minerals, trace minerals, essential proteins (25% pure protein), amino acids, enzymes, co-enzymes, and hormones known to man or 34% amino acid protein. Therefore, the labeling for your product is false or misleading within the meaning of section 403(a)(1) of the Act.
2. Your Thin-Ergy AM product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that the product labeling purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. For example, your brochure, “The Boss of Weight Loss,” shows the Thin-Ergy AM product contains an ingredient identified as Siberian Ginseng (Eleutherococcus senticosus) and your website www.foryouinc.com lists Siberian Ginseng as an ingredient in the Thin-Ergy AM product. That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.
3. Your Pure Chlorella products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labeling bears nutrient content claims, but the products do not meet the requirements to make such claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically, your brochure “Pure Chlorella” makes statements which compare the nutrient content of the product to nutrients in other foods, including:
“Six times more beta-carotene than spinach;
More dietary fiber than leading fruits and vegetables”
Under 21 CFR 101.54(e), a relative claim using the term "more" may be used on the label or in labeling of foods to describe the level of protein, vitamins, minerals, dietary fiber, or potassium, except as limited by 101.13(j)(1)(i) and except meal products as defined in 101.13(l) and main dish products as defined in 101.13(m), provided that:
(1) the product contains at least 10 percent more of the Reference Daily Intake or Daily Reference Value for the nutrient per reference amount customarily consumed than an appropriate reference food,
(2) where the claim is based on nutrients that are added to the food, that the fortification is in accordance with the policy on fortification of foods in 21 CFR 104.20, and
(3) the claim bears the required information for relative claims as described in 21 CFR 101.13(j)(2) and 101.54(e)(1)(iii).
Your Pure Chlorella product label and labeling do not state the identity of a reference food and the percentage (or fraction) of the amount of the nutrient(s) in the reference food by which the nutrient(s) in the labeled food differs. Therefore, the product does not meet the requirements for "more" claims under 21 CFR 101.54(e)(1) and is misbranded within the meaning of section 403(r)(1)(A) of the Act because the labeling bears the nutrient content claim "more" but does not comply with the regulations governing the use of this claim.
4. Your Advanced BioEnzymes and Inner Cellular Energy Multi Vitamin products are 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 the 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) Table 2. For example:
a. The Advanced BioEnzymes label’s directions state to “take one capsule three times daily,” but the serving size listed in the Supplement Facts label is 3 capsules.
b. The Inner Cellular Energy Multi Vitamin label’s directions state to “take two capsules per day, one in the morning, one in the evening.” Thus, the amount recommended on the label per eating occasion is 1 capsule, but the serving size listed in the Supplement Facts label is 2 capsules.
5. Your Youth Factor and Life’s First Food Colostrum products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example:
a. The Youth Factor product label declares the dietary ingredient DHEA, but this is not the common or usual name for this dietary ingredient.
b. The Life’s First Food Colostrum product label fails to declare the source of the dietary ingredient colostrum in accordance with 21 CFR 101.36(d).
6. Your Advanced Formula BioAnti-Oxidant, Advanced BioEnzymes, Calcium pHactor, Thin-Ergy Jr., Ancient Sea Mineral Complex, Inner Cellular Energy Multi Vitamin, Prostate Formula, and Thin- Ergy AM products are 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 nutrition information on the labeling of your products does not comply with 21 CFR 101.36. For example:
a. The Advanced BioEnzymes product label fails to list the quantitative amount by weight for each of the dietary ingredients as required by 21 CFR 101.36(b)(3)(ii)(A).
b. The Calcium pHactor label lists Vitamin D in the wrong order. Vitamin D, its quantitative amount by weight per serving, and percent of the daily value should be listed before calcium in accordance with 21 CFR 101.36(b)(2)(i)(B).
c. The Thin-Ergy Jr. label declares “chromium picolinate.” The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words "as" or "from" (e.g., "Calcium (as calcium carbonate)"), in accordance with 21 CFR 101.36(d). The quantitative amounts by weight shall represent the weight of the dietary ingredient rather than the weight of the source of the dietary ingredient (e.g., the weight of calcium rather than that of calcium carbonate) [21 CFR 101.36(b)(2)(ii)].
d. The Inner Cellular Energy Multi Vitamin label declares the amount of potassium that is less than 2% of the Daily Value. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).
e. The Advanced Formula BioAnti-Oxidant, Advanced BioEnzymes, and Thin-Ergy AM labels fail to indent each of the component dietary ingredients under the proprietary blend dietary ingredients in accordance with 21 CFR 101.36(c)(2).
f. Your Ancient Sea Mineral Complex, Inner Cellular Energy Multi Vitamin, Prostate Formula, and Thin-Ergy AM products’ Supplement Facts labels fail to place a heavy bar between the (b)(2)-dietary ingredients and (b)(3)-dietary ingredients as required by 21 CFR  101.36(e)(6)(ii).
g. The Inner Cellular Energy Multi Vitamin label fails to list Ginkgo biloba with the other (b)(3)-dietary ingredients.
7. Your Thin-Ergy AM and Thin-Ergy Boost products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). For example, the labels fail to declare the specific part of certain plants that use the term “aerial parts.”
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or 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 cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
In addition, we also offer the following comment regarding your labeling:
We note that you include a nutrient content claim about beta-carotene on your product labeling. Your Pure Chlorella product label bears the statement, “It contains unusually large amounts of . . . beta-carotene . . ..“ FDA has not defined the term “unusually large amounts of. . . beta-carotene;” however, under 21 CFR 101.54(b), the terms “high,” “rich in,” or “excellent source of” may be used to characterize the level of a nutrient on the label and in the labeling of foods provided that the food contains 20 percent or more of the Daily Reference Value (DRV) per reference amount customarily consumed (RACC). Furthermore, under 21 CFR 101.54(c), the terms “good source,” “contains,” or “provides” may be used on the label provided that the food contains 10 to 19 percent of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) per RACC.
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.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs mean all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your written response to:
U.S. Food and Drug Administration
Attn: Lakisha N. Morton
Compliance Officer | FDA Atlanta District
Office of Human and Animal Food Operations East Division III
60 – 8th Street NE
Atlanta, GA 30309
If you have questions concerning this letter, you may contact Mrs. Morton at
404-253-1285
, at lakisha.morton@fda.hhs.gov, or write her at the noted mailing address.
Sincerely,
/S/
Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations – East Division 3
Content current as of:
12/01/2020
Regulated Product(s)
Dietary Supplements