The United States Food and Drug Administration (FDA) conducted an inspection of your facility, Princess Lifestyles, LLC., located at 418 E Valley Blvd. San Gabriel, CA 91776 on March 3, 9, and 26, 2021. In February 2022, we also reviewed your website at the Internet addresses www.princesslife.com, where you take orders for your products, including your TMAXX, PS Brain, Hemorlyn, Liver King, B.H. Care, Fucoidan Complex, Tibet Cordyceps Sinensis, Livelyn, Japan Reishi Mushroom, Goldenlife, Stomaisu, Lung Care, and Arthrolyn products. Based on inspectional findings and a review of your website, 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/Misbranded Drug
FDA reviewed your website at the Internet addresses www.princesslife.com, in February 2022 and has determined that you take orders there for your various products, including your TMAXX and PS Brain products. The claims on your website establish the products are drugs under section 201(g)(1)(B) of the Act [21 USC § 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 that provide evidence that your products are intended for use as drugs include:
TMAXX
On your product webpage at https://princesslife.com/
- “Regain control of your body’s metabolism by balancing the…regulation of…cholesterol with Tmaxx.”
PS Brain
On the product webpage at https://princesslife.com/
- “Although studies [of PS, an ingredient in your product] in humans with Alzheimer’s disease were less dramatic, they still produced significant improvements in cognitive function. In patients with mild dementia, significant cognitive and behavioral enhancing effects were observed. Most studies have used a standardized PS that provides an elemental level of 100 mg taken twice per day.”
Your TMAXX and PS Brain 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), 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 product PS Brain is 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 product safely for its intended purposes. Accordingly, your PS Brain product fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Dietary Supplement CGMP Violations
Your dietary supplement products that you manufacture, package, label, and/or hold are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in 21 CFR Part 111. Additionally, even if the product labeling for your TMAXX and PS Brain products did not have therapeutic claims that make these products unapproved new drugs and misbranded drugs, these products would still be adulterated dietary supplements within section 402(g)(1) of the Act because these products have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. Following the March 2021 inspection of your facility, FDA issued a Form FDA 483 Inspectional Observations addressing many of the issues discussed below.
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, you told our investigator that you did not have any written procedures for quality control operations.
In addition, you failed to have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.140(b)(2) [see also 21 CFR 111.127(h)]. Specifically, your firm distributes the dietary supplements that are contract manufactured for you, but you had no records of a quality control review, approval, or rejection for your finished dietary supplement products. During the inspection, you informed our investigator that you do not review the documentation related to the finished dietary supplement products you receive from contract manufacturers to determine if those finished dietary supplement products have met specifications.
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)].
2. You failed to establish component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70. Specifically, you failed to establish an identity specification, as required by 21 CFR 111.70(b)(1). For example, you have not established identity specifications for ingredients you purchase and then supply to your contract manufacturer for the products TMAXX and Livelyn.
3. You failed to establish and follow written procedures for holding and distributing operations, to comply with 21 CFR Part 111.453 that include the requirements for holding components, dietary supplements, packaging, and labels, in accordance with 21 CFR 111.455. Specifically, your firm receives and holds components, finished dietary supplements, packaging, and labels prior to distribution. However, during the inspection, you told our investigator that you had not established and implemented written procedures for holding and distribution operations.
4. You failed to establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements, including the procedures for conducting a material review and making a disposition decision, to comply with 21 CFR 111.503.
During the inspection, you provided our investigator with your firm’s “Credits/Returns Policy,” dated March 1, 2011. This procedure does not include upon receiving a return, instructions for identifying and quarantining returned dietary supplements until quality control personnel conduct a material review and make a disposition decision in accordance with 21 CFR 111.510. Additionally, your firm’s “Credits/Returns Policy” does not include upon receiving a return, instructions for salvaging a returned dietary supplement following a material review and disposition decision to allow the salvage in accordance with 21 CFR 111.520. During the inspection, you informed our investigator that a returned dietary supplement received both within its expiration date and in suitable condition is restocked and redistributed to a different customer.
Moreover, your returned products log does not document that quality control conducts a material review and makes a disposition decision for the returned dietary supplements in accordance with 21 CFR 111.535(b)(2).
5. You failed to establish written procedures for the requirements to review and investigate a product complaint, in accordance with 21 CFR 111.553.
Specifically, you told our investigator that you do not have written procedures for product complaints that include the requirements that apply to the review and investigation of a product complaint.
In addition, you must ensure product complaints are reviewed and investigated as required by 21 CFR 111.560 and written records of product complaints that are related to good manufacturing practice and subsequent investigations are maintained as required by 21 CFR 111.570(b)(2).
Adulterated Dietary Supplement (non-CGMP)
In addition to being an adulterated dietary supplement within the meaning of section 402(g)(1) of the Act, your Stomaisu product is adulterated under section 402(f)(1)(A) of the Act [21 U.S.C. § 342(f)(1)(A)] because it contains a dietary ingredient that presents an unreasonable risk of illness or injury. Specifically, your Stomaisu product label lists Pinellia ternata, a dietary ingredient which contains ephedrine alkaloids, which presents an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use (21 CFR 119.1). Pinellia ternata is a plant listed in the final rule as one of the several species of plants that contain ephedrine alkaloids [Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 FR 6788, 6793 (Feb. 11, 2004)]. Therefore, in accordance with 21 CFR 119.1, your Stomaisu product containing Pinellia ternata is an adulterated dietary supplement within the meaning of 402(f)(1)(A) of the Act [21 U.S.C. § 342(F)(1)(A)].
Misbranded Dietary Supplements
Even if your TMAXX and PS Brain products did not have therapeutic claims that make them unapproved new drugs and misbranded drugs, your products would also be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343]. In addition, your Fucoidan Complex, Tibet Cordyceps Sinensis, Hemorlyn, Livelyn, Japan Reishi Mushroom, Goldenlife, Liver King, Stomaisu, Lung Care, B.H. Care, and Arthrolyn products are misbranded dietary supplements under 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 as follows:
1. Your Arthrolyn product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the specific species of shellfish 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 Arthrolyn product label declares “shells of shellfish” but not the specific type of shellfish present. A declaration of the “species” of 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 we would not object to just the type of Crustacean shellfish, e.g., “Contains shrimp” or “Contains crab.”
2. Your Tibet Cordyceps Sinensis, Hemorlyn, Livelyn, Japan Reishi Mushroom, Goldenlife, Liver King, B.H. Care, and Arthrolyn products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail 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.
3. Your Fucoidan Complex, Tibet Cordyceps Sinensis, TMAXX, Hemorlyn, Livelyn, Japan Reishi Mushroom, Goldenlife, Liver King, Stomaisu, Lung Care, B.H. Care, and Arthrolyn products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because your product labels contain information in two languages but does not repeat all the required label information (including the nutrition information) in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
4. Your Hemorlyn, Livelyn, and Lung Care products are misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the labels are 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:
- The “Directions” for your Hemorlyn product states to take “2-4 capsules per day with meals,” but the serving size lists “2 Capsules.” The serving size listed should be four capsules.
- The “Directions” for your Livelyn product states to take “1 to 3 capsules 3 times daily” but the serving size lists “1 Capsule.” The serving size listed should be three capsules.
- The “Directions” for your Lung Care product states to take “2 capsules 3 times daily” as well as “Children 12 and older may take 2 to 4 capsules daily” but the serving size lists “2 Capsules.” The serving size listed should be four capsules.
5. Your Fucoidan Complex, TMAXX, Hemorlyn, Livelyn, Japan Reishi Mushroom, Goldenlife, Liver King, Stomaisu, Lung Care, and B.H. Care product are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify in English the part of the plant (e.g., root, leaves) for each of the botanical dietary ingredients in the products, as required by 21 CFR 101.4(h)(1). We note “herb” is not a recognized plant part. Furthermore, we note if an entire or whole plant is used, that information must be noted.
6. Your Fucoidan Complex, TMAXX, Hemorlyn, Goldenlife, Stomaisu, Lung Care, B.H. Care, and Arthrolyn product are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each product label fails to declare the common or usual name (standardized common name) or Latin binomial of each ingredient used as required by 21 CFR 101.4(h).
7. Your Fucoidan Complex, TMAXX, Hemorlyn, Goldenlife, Liver King, and Arthrolyn products are each 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,
- The Goldenlife product’s Supplement Facts label lists thiamin as “vitamin B1” and riboflavin as “vitamin B2”. While these alternative names are acceptable synonyms for the listed vitamins, in accordance with 21 CFR 101.36(b)(2)(i)(B)(2), the synonym must parenthetically follow the name of the dietary ingredient.
- The Arthrolyn product’s Supplement Facts label fails to separate the (b)(2)- from the (b)(3)-dietary ingredients with a heavy bar, as required by 21 CFR 101.36(e)(6).
- The Goldenlife product’s Supplement Facts label bears the following statement: “Percent Daily Values based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).
- The Liver King product’s Supplement Facts label declares “containing” prior to the listing of constituents in the Supplement Facts. There is no provision for the word “containing” prior to the listing of constituents in a dietary ingredient in the Supplement Facts label, in accordance with 21 CFR 101.36(b)(iii).
- The Fucoidan Complex, TMAXX, Hemorlyn, Liver King, and Stomaisu products’ Supplement Facts labels each declare quantitative amounts in 1,000 or more milligrams (mg), The quantitative amount of other dietary ingredients must be expressed in appropriate units of measure of measure in accordance with 21 CFR 101.36(b)(3)(ii)(A); 1000 or more units must be declared in the next higher set of units (e.g., 1,000mg must be declared as 1g).
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 cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure or injunction.
We also offer you the following comments:
1. Your firm includes expiration dates on the finished product labels for the dietary supplement products you contract manufacture for distribution. During the inspection, you informed our investigator that you did not conduct or have any data supporting the expiration dates listed on the product labels. Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
2. Please note if the source is “soy” regarding the lecithin declared in the Liver King product ingredient list, the product label must comply with a major food allergen declaration as noted in section 403(w)(1) of the Act.
