Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm489374.htm
Timestamp: 2019-03-24 01:42:16
Document Index: 398536686

Matched Legal Cases: ['§ 321', '§ 321', '§ 321', '§ 321', '§ 331', '§ 352', '§ 352', '§ 352', '§ 331', '§ 321', '§ 343', '§ 342', '§ 342']

ALV Supplement Direct 3/3/16
Refer to MIN 16 - 08
alvSupplement Direct
dba TJM Resale’s Synaptik Supplements & Ligand Solutions
5 Heron Lane
Saint Paul, Minnesota 55127
This letter is to advise you that in June 2015 the U.S. Food and Drug Administration (FDA) reviewed the label for your “Anhydrous Caffeine Bulk Powder” product. In January 2016 the FDA reviewed your website at the internet address www.alvSupplementdirect.com (which redirects to www.synaptiksupplements.com) and has determined that you take orders there for the product “Anhydrous Caffeine Bulk Powder.” This product is offered in powdered form, and its label lists “pure Caffeine powder >99%” as the sole ingredient. The claims on your website establish that “Anhydrous Caffeine Bulk Powder” is a drug under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(C), because it is intended to affect the structure or any function of the body. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Based on our review, we have determined that the claims on your website promote this product for conditions that cause it to be a drug under section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g)(1)(C), because it is an article (other than food) intended to affect the structure or any function of the body. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution. See, e.g., Title 21, Code of Federal Regulations, section 201.128 (21 CFR 201.128).
The claims observed on your website www.alvSupplementdirect.com, indicating that “Anhydrous Caffeine Bulk Powder” is intended to affect the structure or any function of the body include, but may not be limited to, the following:
“Whether you just need that extra pick-me-up to get your day going or boosting your energy for work or fitness, Pure [sic] caffeine will do the trick.”
“It can be helpful as a fat-burner in that it speeds up your metabolism making you more active, and as an effective appetite suppressant…”
“…also increase focus.…”
The above-mentioned claims cause your product “Anhydrous Caffeine Bulk Powder” to be a drug under section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g)(1)(C). Furthermore, this product is a “new drug,” as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because its composition is such that it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.
Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. There is no FDA-approved application in effect for your “Anhydrous Caffeine Bulk Powder” product. Consequently, your marketing and sale of this product violates these provisions of the Act.
In addition, “Anhydrous Caffeine Bulk Powder” is a misbranded drug under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
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. As discussed below, there is a potential for serious adverse events associated with the use of this product.
“Anhydrous Caffeine Bulk Powder” is misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), because the product labeling does not contain sufficient information to enable laypersons to use this product safely and for the purposes for which it is intended (described above), including: frequency of administration, duration of administration, time of administration, route or method of administration, and preparation for use.[1] Moreover, any such information would not provide adequate directions for use, given that consumers are unlikely to have a measuring tool to accurately measure an appropriate serving size for this product.[2] (See 21 CFR 201.5.) 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). (See 21 CFR 201.5(c), (d), (e), (f) and (g).)
Adulterated Dietary Supplement
Your product is not labeled as a dietary supplement, and it therefore does not meet the definition of a dietary supplement. See section 201(ff)(2)(C) of the Act, 21 U.S.C. § 321(ff)(2)(C). However, we note that your product label prominently bears the name of your website alvSupplementdirect.com which contains the word “supplement.” We also note that your website contains a statement that closely resembles the statement required under section 403(r)(6)(C) of the Act, 21 U.S.C. § 343(r)(6)(C), for dietary supplements that make certain labeling claims. Based on your use of this statement and the name of your website, it appears you may intend to market your product as a dietary supplement. If you were to market your product in such a way as to meet the definition of a dietary supplement, it would be adulterated under section 402(f)(1)(A)(i) of the Act, 21 U.S.C. § 342(f)(1)(A)(i), because it presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.
Your label states: “Serving Size: 50mg-100mg.” Depending on the density of the powder, we estimate that a serving of 50 to 100 milligrams would be approximately 1/54th to 1/27th of a teaspoon.[3] This amount cannot be accurately measured using common household measuring tools. Many consumers do not have a scale that is sufficiently precise to accurately measure such a small amount.
Caffeine is a powerful stimulant. A single teaspoon of pure powdered caffeine is roughly equivalent to the amount in 28 cups of coffee (approximately 2.7 grams[4]). Consuming as little as one teaspoon of caffeine has been associated with symptoms including nausea, vomiting, anxiety, and heart palpitations. Consuming as little as one tablespoon (equivalent to 3 teaspoons or approximately 8.1 grams) of caffeine has been associated with symptoms including chest pain, hypokalemia, elevated blood glucose, tachycardia, bigeminy, agitation, respiratory alkalosis, irregular heartbeat, and in some cases, even death.
Your product consists of a package containing 50 grams (approximately 18 tablespoons) of powdered caffeine, which is 500-1,000 recommended servings of the product. In light of the potential toxicity of your product, the fact that your product is packaged to contain an amount that would be lethal to many consumers, and the fact that the packaging requires the consumer to use a precise scale to separate out a safe serving from this potentially lethal amount, we have determined that your product presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling. Therefore, as discussed above, if you were to market your product as a dietary supplement it would be adulterated under section 402(f)(1)(A)(i) of the Act, 21 U.S.C. § 342(f)(1)(A)(i).
We note that your product label states “For manufacturing purposes only, not for direct consumption,” but this assertion is insufficient to overcome other representations that indicate that your product is intended for direct consumption by purchasers. For example, your product label contains a serving size that seems aimed at individual users. Your product label also states “Not for use by those under 18 years,” which is a statement that seems inapplicable to a powdered caffeine product that is only intended for manufacturing. Furthermore, your website contains statements that indicate that the product is intended for direct consumption by individual consumers, such as “Whether you just need that extra pick-me-up to get your day going or boosting your energy for work or fitness, Pure [sic] caffeine will do the trick,” and “increase focus if you are a College [sic] student and need to put in those all night cram sessions.”
The above violations are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for ensuring that all of your products are in compliance with the Act and all applicable FDA regulations.
You should take prompt action to correct the violations cited above and to prevent their reoccurrence. Failure to do so may result in legal action without further notice, including seizure and/or injunction.
Please respond in writing within 15 working days of receipt of this letter. Your response should outline the specific steps you have taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of steps you have taken to ensure that similar violations do not recur, as well as documentation to support your response. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written reply should be directed to Demetria Lueneburg, Compliance Officer, Food and Drug Administration, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota 55401. If you have any questions with regard to this letter, please contact Ms. Lueneburg at (612) 758-7210 or demetria.lueneburg@fda.hhs.gov.
[1] As noted below, the statements on your website and label indicate that your product is intended for use by consumers, notwithstanding that your label states “For manufacturing purposes only, not for direct consumption.”
[2] We note below that a serving size of your product is estimated to be approximately 1/54th to 1/27th of a teaspoon.
[3] Due to the nature of producing a powdered crystalline substance, there may be differences in the density of different powdered caffeine products even when the products are the same chemical substance. Our reported values for a teaspoon and tablespoon of powdered caffeine are based on peer reviewed literature, which indicates that the poured bulk density of powdered caffeine is 0.55 g/mL; therefore, one standard teaspoon is 2.7 g and one standard tablespoon is 8.1 g.
[4] The USDA nutrition database reports that one cup (8 oz) of ground coffee contains 95 mg of caffeine (http://ndb.nal.usda.gov/ndb/foods/show/4277).
Page Last Updated: 03/10/2016