Eden s Answers Inc. and Sprigs Life Inc. 12/14/17

Transcription

1 Eden s Answers Inc. and Sprigs Life Inc. 12/14/17 Cincinnati District Office 6751 Steger Drive Cincinnati, OH Telephone: (513) FAX: (513) December 14, 2017 VIA UPS Overnight Delivery Jonathan Laudon, Owner Nancy Laudon, Owner Eden s Answers Inc. and Sprigs Life Inc S. Florida Avenue Lakeland, FL Dear Mr. Laudon and Ms. Laudon: WARNING LETTER From August 1 through August 17, 2017 the U.S. Food and Drug Administration (FDA) conducted an inspection of your facilities (Eden s Answers Inc. and Sprigs Life Inc.) located at 13754A Lawnfield Street SW, Beach City, Ohio. Based on the inspection, a review of the product labels collected during the inspection, and a review of your website at we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA s website at ( Unapproved New Drugs/Misbranded Drugs FDA reviewed your website at the Internet address in October 2017 and has determined that you take orders there for the products Pedia Para-Free, Lil Ones Breathe Easy, Respiratory Aid, Raw Elderberry and Honey, and Women s Hormonal Help Life Stage 2. The claims on your website establish that these 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

2 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: Pedia Para-Free Parents favorite for: Pinworms, Tapeworm, Hookworm, Roundworm, Flatworm blood fluke, Giardia, Toxoplasma Lil Ones Breathe Easy Fights congestion Parents favorite for: Seasonal Allergies, Colds, Flu, Congestion, Runny Nose, Sinus Infections When allergies and colds are sweeping through your house, Lil Ones Breathe Easy can help Respiratory Aid Fights congestion, naturally Customers favorite for: Cough, Cold, Flu, Bronchitis, Emphysema Respiratory Aid gives your body the support it needs for handling congestion Raw Elderberry and Honey Customers favorite for: Cold, Flu, Infection, Inflammation, Mucus, Sinus Infection, Hay Fever Women s Hormonal Help Life Stage 2 Customers favorite for: Depression Postpartum, Endometriosis 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 Respiratory Aid and Women s Hormonal Help Life Stage 2 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 these products safely for their intended purposes. Accordingly, Respiratory Aid and Women s Hormonal Help Life Stage 2 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)

3 (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)]. Misbranded Dietary Supplements Further, even if your Pedia Para-Free, Lil Ones Breathe Easy, Respiratory Aid, and Raw Elderberry and Honey products were not unapproved new drugs, these products would still be misbranded within the meaning of section 403 [21 U.S.C. 343] of the Act, and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101. Specifically during the inspection of your facility, our investigator collected labels associated with many of your products, including those listed above and your Lil Ones Calm and Focus. Our review of your product labels revealed that your products are misbranded within the meaning of section 403 of the Act [21 U.S.C. 343], as follows: 1. Your Respiratory Aid, Pedia Para-Free, Raw Elderberry and Honey, Lil Ones Calm and Focus, and Lil Ones Breathe Easy products are misbranded within the meaning of section 403(q) (1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] in that 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 (b) Table 2. For example, Your Respiratory Aid product label suggests consumers take 2 droppers hourly but the nutrition information is based on 1 drop. The serving size should be listed as 2 droppers. Your Pedia Para-Free product label suggests children 40 pounds or more take one dropper three times a day, but the serving size is listed as 1 drop. Your Raw Elderberry and Honey product label indicates a range for the serving size rather than the maximum amount per eating occasion. Furthermore, the label s serving size must include the equivalent metric quantity in parentheses following the common household measure. Your Lil Ones Calm and Focus product label suggests ages 10 years and up take 30 drops 3 times daily, but the serving size is ½ tsp. The serving size should be listed as 30 drops. Your Lil Ones Breathe Easy product label suggests adults take drops 3 times daily, but the serving size is 2/3 tsp. The serving size should be listed as 40 drops. 2. Your Respiratory Aid, Pedia Para-Free, and Lil Ones Breathe Easy 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 does not comply with 21 CFR For example, dietary ingredients for which RDIs or DRVs have not been established are not listed within the Supplement Facts panel in accordance with 21 CFR (b)(3). 3. Your Respiratory Aid, Raw Elderberry and Honey, Lil Ones Breathe Easy, and Pedia Para- Free products are misbranded within the meaning of section 403(s)(2)(A)(ii)(I) and 403(q)(5)(F) of the Act [21 U.S.C. 343 (s)(2)(a)(ii)(i) and 403(q)(5)(F)] in that the labels fail to include the quantitative amount per serving size of all the dietary ingredients, as required by 21 CFR Your Raw Elderberry and Honey product is misbranded within the meaning of section 403(q) (1)(B) of the Act [21 U.S.C. 343 (q)(1)(b)] because the label fails to declare the correct number of servings per container in accordance with 21 CFR (b)(1)(ii). Specifically, the number of servings is stated as a range instead of one value.

4 5. Your Respiratory Aid, Raw Elderberry and Honey, Menstrual Ease, Pedia Para-Free, Lil Ones Calm and Focus, and Lil Ones Breathe Easy products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. 343(s)(2)(C)], in that the labels fail 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). The violations cited in this letter are not intended to be an all-inclusive list 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 the Act and all implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action such as seizure and/or injunction without further notice. We also offer the following comments: Your Testo Strong XY product labeling information that appears on your website lists the ingredient Siberian Ginseng. 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. Specifically, your product contains an ingredient identified as Siberian Ginseng which is Eleutherococcus senticosus. That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax. Furthermore, the Testo Strong XY labeling on your website 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). Your Respiratory Aid, Raw Elderberry and Honey, and Pedia Para-Free product labels must present the name and place of business on the principal display panel or the information panel in accordance with 21 CFR 101.2(b). Further, we note that your Respiratory Aid and Raw Elderberry and Honey products list Evergreen Distributing, the former name of Sprigs Life, as the business name. Your Raw Elderberry and Honey product includes raw clover honey as an ingredient. If dietary ingredients such as sugar, total carbohydrate, or calories are present in significant amounts per serving, they must be declared in the Supplement Facts (see 21 CFR (b)(2)). Your Menstrual Ease product label suggests consumers take (1/2-1 tsp) in 4 oz. of water. There is no unit stated for You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent these violations and copies of supporting documentation such as evidence of your revised and corrected web pages. If you cannot complete corrective actions within fifteen (15) business days, state the reason for the delay and the date by which these activities will be completed. Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Stephen J. Rabe, Compliance Officer; 6751 Steger Drive, Cincinnati, OH or via at Stephen.rabe@fda.hhs.gov (mailto:stephen.rabe@fda.hhs.gov). You may reach Mr. Rabe at , extension 2163 if you have any questions about this matter.

5 Sincerely, /S/ Acting, Director, Division V Office of Human and Animal Foods Operations - East Cc: Leroy J. Miller, Production Manager Eden s Answers Inc./Sprigs Life, Inc A Lawnfield Street SW Beach City, Ohio More in 2017 (/ICECI/EnforcementActions/WarningLetters/2017/default.htm)