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WARNING LETTER

Maine Natural Health, Inc. MARCS-CMS 525870 —

Recipient:
Recipient Name
Mr. Harold J. Leighton
Maine Natural Health, Inc.

825 Atlantic Hwy
Warren, ME 04864-4617
United States

Issuing Office:
New York District Office

United States

 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Food Operations East - Division 1 

 
 

 

WARNING LETTER
CMS # 525870
 
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
December 19, 2017 
 
Mr. Harold J. Leighton
Owner and CEO
Maine Natural Health, Inc.
825 Atlantic Hwy
Warren, ME 04864-4617
 
 
Dear Ms. Leighton:
 
On April 10, 2017 through April 12, 2017, April 24, 2017 through April 26, 2017 and May 3, 2017, the U.S. Food and Drug Administration (FDA or we) inspected your firm located at 825 Atlantic Hwy, Warren, Maine. During the inspection, our investigator found a number of violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplement products Vanilla Recovery Whey Protein and Peppermint SO3+D3 Fish Oil to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements in 21 CFR Part 111.  
 
In addition, we have reviewed the labeling for your dietary supplements, including product labels and your website at www.sfh.com. Based on our review of the labeling and the website, we have concluded that your SO3 + D3 Fish Oil, Fuel Whey Protein, Strong Strength + Muscle, Pure Whey Protein, and Push Pre-Workout products are in violation of Section 403 of the Act [21 U.S.C. §§ 343] and regulations implementing the food labeling requirements of the Act, which are found in 21 CFR 101. 
 
Furthermore, FDA reviewed your website at the Internet address www.sfh.com in July, 2017, and has determined that you take orders there for the products SO3 + D3 Fish Oil, SO3 Fish Oil, Recovery Whey Protein, Strong Strength + Muscle, and Pure Whey Protein. 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 prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
 
You can find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
 
We have received your letters dated May 17, 2017 and September 6, 2017 in response to the Form FDA 483, Inspectional Observations, issued to you at the conclusion of this inspection on May 3, 2017 and have incorporated our review of its adequacy below.
 
Your significant violations are as follows:
 
Unapproved New Drugs
 
As explained above, the claims on your website establish that your SO3 + D3 Fish Oil, SO3 Fish Oil, Recovery Whey Protein, Strong Strength + Muscle, and Pure Whey Protein products are drugs under section 201(g)(1)(B) of the Act because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
SO3 + D3 Fish Oil
  • “Vitamin D [an ingredient in the product] may improve heart health…. heart disease is the leading cause of death in the US, which makes vitamin D an important nutrient.”
  • “Benefits of fish oil [an ingredient in the product] include: reduced inflammation”
  • “[T]he omega-3 fatty acids in fish oil [an ingredient in the product]….have shown beneficial results for a variety of health problems….like high blood pressure and arthritis. This means regular consumption of fish oil may help stave off disease….”
  • “[F]ish oil [an ingredient in the product] may play a key role in preventing preterm births, which is the leading cause of perinatal mortality and morbidity….fish oil targets premature cervical ripening, a cause of preterm birth”
  • “[O]mega-3 fatty acids found in fish oil [an ingredient in the product]….intake of omega-3s….may also help women fight postpartum depression….could reduce depressive symptoms in women…”
  • Omega-3 Index Assay brochure, available for download from the website www.sfh.com,  contains statements alongside photo of product: “….omega-3 oil [an ingredient in the product] supplementation ….doses of 3 to greater than 6 grams a day may provide…. 4.0G TO > 6.0G inflammation control…..” 
SO3 Fish Oil
  • Omega-3 Index Assay brochure, available for download from the website www.sfh.com, contains statements alongside photo of product: “….omega-3 oil [an ingredient in the product] supplementation ….doses of 3 to greater than 6 grams a day may provide…. inflammation control…..”
  • Your Partners in Wellness brochure, available for download from the website www.sfh.com, contains a photo of the product alongside the statements, “trauma, infections…inflammation induces joint and muscle pains…stimulates progressive tissue destruction…recommended treatments…prescribe SFH high strength liquid Omega-3 oils” 
Recovery Whey Protein
  • “[G]rass fed whey [an ingredient in the products]….naturally higher in Omega-3…benefits include: reduces inflammation….reduces risk of irregular heartbeats…reduce risk of plaque buildup in arteries….”
  • “[R]ibose [promoted as a constituent in the product] mandatory prescription for individuals suffering heart problems….”
  • “[C]arnitine [promoted as a constituent in the product] assists with…less likely hood [sic] of heart disease + diabetes”
  • “Additional benefits…assist with bad cholesterol.
  • “[A]lso found in Recovery are..omega-3s…may help to reduce inflammation….reduce the risk of plaque buildup in the arteries.” 
Strong Strength + Muscle
  • “L-glutamine [promoted as a constituent in the product]…has even been used to treat severe burns and wounds and other chronic health issues…”
Pure Whey Protein
  • Your Partners in Wellness brochure, available for download from the website www.sfh.com,, contains a photo of the product alongside statements, “joint, knee, and back pain…diabetes, heart disease and possibly cancer…obesity…Recommended Treatments…use SFH protein supplements”
Your website also contains evidence of intended use in the form of responses to consumer comments that  promote the use of SO3 Fish Oil for the cure, mitigation, treatment, or prevention of disease. Examples of such responses include:
  • “Looking for fish oil to help my son’s eczema….For your son, we recommend our omega-3 without Vit. D3…”
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) of the Act [21 U.S.C. 321(p)]. 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 products SO3 + D3 Fish Oil, Recovery Whey Protein, and Pure Whey Protein 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, SO3 + D3 Fish Oil, Recovery Whey Protein, and Pure Whey Protein 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
 
Even if your  Peppermint SO3 + D3 Fish Oil and Vanilla Recovery Whey Protein products were not unapproved new drugs and misbranded drugs, they would still be adulterated dietary supplements under section 402(g)(1) of the Act [21 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. Our inspection of your facility revealed violations of  21 CFR Part 111, including:
 
1.    You failed to establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a). Specifically:
 
a.  You failed to establish identity specifications for each component used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). For example, the specification sheets for the dietary ingredients chondroitin sulfate, creatine monohydrate, and n-acetyl L-carnitine, all of which are ingredients in your Vanilla Recovery Whey Protein product, do not include specifications for identity.
 
b.  You failed to establish component specifications that are necessary to ensure that specifications for the purity and strength of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). For example, your specifications for chondroitin sulfate, creatine monohydrate, and n-acetyl L-carnitine, all of which are ingredients in your Vanilla Recovery Whey Protein product, have purity specifications that do not represent purity. Purity is the portion or percentage of dietary ingredient that it is purported to be and that represents the intended ingredient. Instead, your component specification list contaminants that may be present (microbial and heavy metals).
 
c.  Under 21 CFR 111.70(e), for each dietary supplement that you manufacture, you are required to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, to ensure the quality of the dietary supplement. For several of your dietary supplement products, your finished product specifications are inadequate to ensure the quality of the dietary supplement. For example:
  • Your finished product specifications for your Vanilla Recovery Whey Protein and Peppermint SO3 + D3 Fish Oil products list (b)(4), which alone are not sufficient to determine the identity of these finished products.
  • Your finished product specifications fail to include all of the ingredients used in the products, including rebaudioside A, natural vanilla flavor, and sunflower lecithin that are used in your Vanilla Recovery Whey Protein product, and the natural peppermint flavor and mixed natural tocopherols used in your Peppermint SO3 + D3 product.
Further, we question whether the theoretical analytical specifications for the ingredients in your Vanilla Recovery Whey Protein product are consistent with the actual amounts of ingredients used, when compared to the batch records provided for the products. For example, we note that your specifications for Vanilla Recovery Whey Protein list a specification for the ingredient whey protein of (b)(4), with a range of (b)(4). However, according to your batch records, you added whey protein to the batch at a level of approximately (b)(4) by weight to Vanilla Recovery Whey Protein lot (b)(4).
 
Additionally, your finished product specifications for Peppermint SO3 + D3 Fish Oil include specifications for vitamin D3 that allow for as little as (b)(4) and as much as (b)(4) of the 1000 IU/serving that is declared on the product label. We question why your specification allows for such a wide variation in the strength of the nutrient in the finished product. Moreover, vitamin D3 is a class I nutrient in this product, in that it is an added nutrient in a fortified or fabricated food (21 CFR 101.9(g)(3)). As such, please be advised that under 21 CFR 101.9(g)(4)(i) the nutrient content of the food should be at least equal to the value for that nutrient as it is declared on the label.
 
We have reviewed your firm’s responses, dated May 17, 2017, and September 6, 2017, and determined your responses to be inadequate because you did not provide evidence that you have established appropriate component and finished product specifications for your Vanilla Recovery Whey Protein and Peppermint SO3 + D3 Fish Oil products.
 
2.    Your firm failed to collect representative samples of a subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify that the finished batch of dietary supplement meets product specifications, as required by 21 CFR 111.80(c).
 
Specifically, our inspection found that you are not collecting representative samples of each finished product batch of your Vanilla Recovery Whey Protein Concentrate before releasing for distribution to verify that the finished batch of dietary supplement meets established product specifications.
 
Your firm’s May 17, 2017 response indicates that you will commit to finished product sampling and testing of all batches of your dietary supplements and you provided an estimated completion date of June 30, 2017 to implement this correction. However, to date you have not provided documented evidence that you are collecting representative samples.
 
3.    When a dietary supplement failed to meet an established specification, your quality control personnel did not reject the component or dietary supplement, nor did they approve a treatment, an in-process adjustment, or reprocessing that would ensure the quality of the finished dietary supplement and that the dietary supplement was packaged and labeled as specified in your master manufacturing record (MMR), as required by 21 CFR 111.77(a) and 111.113(b)(2). Specifically, out of specification results were received for components that weren’t rejected, but were used in the manufacture of your dietary supplements as follows:
 
a.  The raw material test results for the potency of Chondroitin Sulfate, manufacturer lot (b)(4) was found to be (b)(4) total chondroitin sulfate and your specification is (b)(4). This component was used to manufacture the dietary supplement Vanilla Recovery Whey Protein lot (b)(4).
 
b.  The raw material test results for the potency of Chondroitin Sulfate, manufacturer lot (b)(4) was found to be (b)(4) total chondroitin sulfate and your specification is (b)(4). This component was used to manufacture the dietary supplement Vanilla Recovery Whey Protein lot (b)(4) and lot (b)(4).
 
c.  The raw material testing results for the potency of Creatine monohydrate, manufacturer lot (b)(4) was found to be (b)(4) and your specification is (b)(4). This component was used to manufacture the dietary supplement Vanilla Recovery Whey Protein lot (b)(4).
 
d.  Your raw material testing results for the potency of Acetyl-L-Carnitine HCL, manufacturer lot (b)(4) was found to be (b)(4) and your specification is (b)(4). This component was used to manufacture the dietary supplement Vanilla Recovery Whey Protein lot (b)(4) and lot (b)(4).
     
Further, you failed to document the material review and disposition decision and follow up, as required by 21 CFR 111.140(b)(3) to support the use of Chondroitin Sulfate, manufacturer lot (b)(4), Chondroitin Sulfate, manufacturer lot (b)(4), Creatine monohydrate, manufacturer lot (b)(4), and Acetyl-L-Carnitine HCL, manufacturer lot (b)(4) used in the manufacture of Vanilla Recovery Whey Protein lot (b)(4) and lot (b)(4) when these components did not meet established specifications. Specifically, such documentation must include:
  • Identification of the specific deviation or the unanticipated occurrence [21 CFR 111.140(b)(3)(i)];
  • Description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence [21 CFR 111.140(b)(3)(ii)];
  • Evaluation of whether or not the deviation or unanticipated occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement [21 CFR 111.140(b)(3)(iii)];
  • Identification of the action(s) taken to correct, and prevent a recurrence of, the deviation or the unanticipated occurrence [21 CFR 111.140(b)(3)(iv)];
  • Explanation of what you did with the components and dietary supplement [21 CFR 111.140(b)(3)(v)];
  • A scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected [21 CFR 111.140(b)(3)(vi)].    
Your firm’s May 17, 2017 response indicates that you have evaluated the specific instances where you used components that did not meet established specifications. However, we find your response is inadequate in that you have not provided documentation that you have adequately investigated and documented the out of specification results, or of your justification to support the use of the components, as required by 21 CFR 111.140(b)(3). Further, you have not provided evidence, such as a quality control procedure, that demonstrates that you have taken steps to prevent this from recurring in the future.
 
4.    You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch, from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection we noted that you are not preparing master manufacturing records that are unique to the batch sizes being manufactured for each of your dietary supplements. For example, our review of your records indicated that on May 5, 2016, you manufactured one batch of Vanilla Recovery Whey Protein using (b)(4) with a final batch size of (b)(4) and on July 5, 2016, you manufactured another batch of the same product using (b)(4) with a final batch size of (b)(4) following the same master manufacturing record for each batch.
 
Additionally, in preparing your master manufacturing records for all dietary supplements you manufacture, you must ensure that they meet the requirements of 21 CFR 111.210. For example, the current master manufacturing record for Vanilla Recovery Whey Protein does not include the strength, concentration, weight, or measure of each dietary ingredient for each batch size, as required by 21 CFR 111.210(a).
 
We have reviewed your response letter, dated May 17, 2017, which states that your QC unit is updating your MMRs to include the required information; however, you did not provide updated MMRs as evidence of this corrective action to date.
 
Misbranded Dietary Supplements
 
Even if your labeling did not contain claims that cause your Peppermint SO3 + D3 Fish Oil, Strong Strength + Muscle, and Pure Whey Protein products to be unapproved new and misbranded drugs, they would still be misbranded foods under section 403 of the Act (21 U.S.C. § 343), as are your Coconut Fuel Whey Protein and Push Pre-Workout products, as follows:
 
1.    Your Strong Strength + Muscle, and Push Pre-Workout products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that their labeling is false and misleading. First, your website www.sfh.com contains false statements that certain ingredients in the products provide antioxidant activity. For example:
 
a.  Your Strong Strength + Muscle product page contains the statements, “The powerful combination of serum protein concentrate (SPC), creatine and glutamine … has powerful antioxidant properties …,” and “Serum Protein Concentrate….anti-oxidant – high concentration of transferrin which binds free iron.”
 
However, although the dietary ingredient serum protein concentrate contains transferrin, the transferrin does not act as an antioxidant in the human body because it is digested into amino acids after ingestion. Furthermore, creatine and glutamine are not antioxidants.
 
b.  Your Push Pre-Workout product page contains the statement, “Antioxidants: Vitamin C & E, along with glycine plus arginine.” However, glycine is not considered to be an antioxidant.
 
2.    Your Pure Whey Protein and Fuel Whey Protein  dietary supplement 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 labeling bears nutrient content claims, but the products do not meet the requirements to bear the 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 the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling without complying with the specific requirement pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically:
 
a.  Your Pure Whey Protein product page on your website www.sfh.com bears the claims, “Pure Whey … is low in cholesterol, and high in free calcium,” and “Our clean whey is naturally a rich source of essential amino acids.” However, this product does not meet the requirements that are set forth in 21 CFR 101.62(d)(2) and 21 CFR 101.54(b) for use of these nutrient content claims.
 
To make a low cholesterol claim, the product must contain 20 mg or less cholesterol per reference amount customarily consumed (RACC) and per 50 grams of product, as required by 21 CFR 101.62(d)(2)(ii)(A). The RACC for a dietary supplement is the maximum amount recommended on the label for consumption per eating occasion, 21 CFR 101.12 Table 2. In the case of your chocolate flavor Pure Whey Protein, the RACC is 30 grams. However, according to the product’s Supplement Facts label, the product contains 25 mg of cholesterol per the 30-gram RACC, and therefore does not meet the requirement to make the low cholesterol claim.
 
Further, 21 CFR 101.54(b) states that a product must contain 20% or more of the reference daily intake (RDI) or Daily Recommended Value (DRV) per RACC in order to bear a “high” claim. The RDI for calcium is 1000 mg, and the RACC for your chocolate flavor Pure Whey Protein is 30 g. According to the Supplement Facts, your product contains 110 mg of calcium per 30 g, which is only 11% of the RDI.
 
Additionally, under 21 CFR 101.54(b)(1) the term “rich” may be used in the labeling of foods provided that the food contains 20% or more of the RDI or DRV of the nutrient for which the claim is made, per RACC. This regulation does not authorize claims about amino acids, as amino acids do not have either an established RDI or DRV.
 
b.  Your Fuel Whey Protein product page contains the statement, “Apple Pectin [an ingredient in the product]: is….rich in water soluble fibers.” Under 21 CFR 101.54(b)(1), the term, “rich” may be used in the labeling of foods provided the food contains 20% or more of the RDI or DRV of the nutrient for which the claim is made, per RACC. The DRV for fiber is 25 grams, and the RACC for this product is 30 grams. However, according to the Supplement Facts label, a 30-gram serving of the product contains just 1 gram, or 4% of the DRV of fiber.
 
c.  Your Chocolate Pure Whey Protein product bears the claim “low lactose content”. FDA has not defined nutrient content claims for lactose; therefore, the use of this claim misbrands your product under 403(r)(1)(A).
 
3.    Your Peppermint SO3 + D3 Fish Oil, Coconut Fuel Whey Protein, and Coffee Strong Strength + Muscle products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that they are fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Specifically:
 
a.  The Peppermint SO3 + D3 Fish Oil ingredient list does not declare corn oil, which is a sub-ingredient in the vitamin D3 ingredient, as an “other ingredient,” in accordance with 21 CFR 101.4(g).
 
b.  According to the batch records provided during the inspection, the ingredient rebaudioside A is an ingredient in Peppermint SO3 + D3 Fish Oil. However, it is not declared on the product label, in accordance with 21 CFR 101.4.
 
c.  Your Coconut Fuel Whey Protein label lists “MCTs” in the Supplement Facts label. “MCTs” is not the common or usual name of an ingredient, in accordance with 21 CFR 101.4.
 
d.  Your Coffee Strong Strength + Muscle product label fails to declare the source of the serum protein concentrate as part of the nutrition information, in accordance with 21 CFR 101.4(g) and 21 CFR 101.36(d).
 
4.    Your Peppermint SO3 + D3 Fish Oil, Coconut Fuel Whey Protein, Chocolate Pure Whey Protein, Fruit Punch Push Pre-Workout, and Coffee Strong Strength + Muscle products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36 and 21 CFR 101.9. Specifically:
 
a.  The Peppermint SO3 + D3 Fish Oil Supplement Facts label lists Vitamin D3, a “(b)(2)” dietary ingredient (21 CFR 101.36(b)(2)), beneath a heavy bar with the omega-3 fatty acids, and separated from the other (b)(2) dietary ingredients total calories, calories from fat, total fat. Similarly, the Fruit Punch Push Pre-Workout label lists (b)(2) vitamins and minerals in an incorrect order and separated from other (b)(2) dietary ingredients total calories, cholesterol, total carbohydrates, and sugars. “(b)(2)” dietary ingredients are required to be listed with other (b)(2) dietary ingredients, and separated from the (b)(3) dietary ingredients (such as omega-3 fatty acids and amino acids) by means of a heavy bar, in accordance with 21 CFR 101.36(e)(6)(ii) and vitamins and minerals must be listed in the correct order in accordance with 21 CFR 101.36(b)(2)(i)(B).
 
b.  Your Coffee Strong Strength + Muscle and Coconut Fuel Whey Protein product labels declare an incorrect percent of Daily Value relative to the cholesterol. Likewise, your Peppermint SO3 + D3 Fish Oil Supplement Facts label similarly lists an incorrect percent of Daily Value for Vitamin D3. Similarly, your Chocolate Pure Whey Protein declares an incorrect percent of Daily Value for saturated fat in accordance with 21 CFR 101.9(c)(8) and (9).
 
c.  Your Coconut Fuel Whey Protein product label declares incorrectly the quantitative amount of carbohydrate. The grams of carbohydrate should be rounded to the nearest whole number in accordance with 21 CFR 101.9(c)(6).
 
d.  Your Coconut Fuel Whey Protein and Coffee Strong Strength + Muscle product labels appear to declare an incorrect number of calories relative to the quantitative amounts of macronutrients (carbohydrate, fat, and protein) that are listed in accordance with 21 CFR 101.9(c)(1)(i)(C).
 
e.  Your Fruit Punch Push Pre-Workout label lists a value of zero (0) for cholesterol/† daily value not established for calcium in the Supplement Facts labels, and your Coffee Strong Strength + Muscle label lists one calorie from fat, and 0.13 grams of total fat and saturated fat, and 1% calcium in the Supplement Facts label. Cholesterol, calcium, and fat are “(b)(2)” dietary ingredients, which must not be declared unless they exceed the quantitative amount by weight that exceeds the amount that can be declared as zero in accordance with 21 CFR 101.36(b)(2).
 
f.  Your Coffee Strong Strength + Muscle label does not have the total calories value rounded correctly in accordance with 21 CFR 101.9(c)(1)(ii).
 
5.    Your Coconut Fuel Whey Protein, Chocolate Pure Whey Protein, Fruit Punch Push Pre-Workout, and Coffee Strong Strength + Muscle products are misbranded within the meaning of section 403(q)(1)(A) because the serving sizes and servings per container are not listed in the Supplement Facts labels in the format required by 21 CFR 101.36(b).
 
6.    Your Peppermint SO3 + D3 Fish Oil and Fruit Punch Push Pre-Workout products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the product labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Specifically, the labels do not list the name of the manufacturer, packer, or distributor.
 
7.    Your Fruit Punch Push Pre-workout and Coffee Strong Strength + Muscle products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7(b)(1). The Fruit Punch Push Pre-workout label lists the net weight in total ounces, rather than pounds and ounces. The Coffee Strong Strength + Muscle product fails to list US measure (pounds, ounces).
 
This letter is not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. 
 
You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to do so may result in enforcement action, without further notice, including, but not limited to, seizure and/or injunction.
 
We have the following additional comments:
 
a.  All information appearing on the information panel that is required to be declared on the product label must be listed together without intervening material, section 21 CFR 101.2(e). However, there is intervening material, such as Suggested Use statements, amino acid profile information, and graphics, between the Ingredients lists and address on the Peppermint SO3 + D3 Fish Oil, Coconut Fuel Whey Protein, Chocolate Pure Whey Protein, Fruit Punch Push Pre-Workout, and Coffee Strong Strength + Muscle product labels. Also, the address is on the wrong panel of the Peppermint SO3 + D3 Fish Oil label.
 
b.  Your website www.sfh.com states that your Peppermint SO3 + D3 Fish Oil is made from Alaskan Pollock, sardines, herring, and anchovies. However, Alaskan Pollock is not listed in either the ingredient statement or the “Contains” statement on the product label. The ingredient statement lists “purified fish oil,” and the “Contains” statement lists “Fish (anchovies, sardines and herring).”
 
If your product does not contain Alaskan Pollock, your website should be corrected. If your product does contain Alaskan Pollock, you should be aware that under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the specific species of fish contained in a food product must be listed either in the ingredient statement (in parentheses following the common or usual name of the relevant ingredient) or in a “Contains” statement. Please note that if a product label has a “Contains” statement, the statement must include the names of the food sources of all major food allergens used as ingredients in the food.  
 
c.  Your Coconut Fuel Whey Protein product label lists coconut fat, a source of dietary ingredients, within the Supplement Facts label, but lists whey concentrate, also a source of dietary ingredients, in an “Ingredient” list below the Supplement Facts label. In such a case the list of ingredients that is outside the Supplement Facts label must be preceded by the words, “Other ingredients,” per 21 CFR 101.4(g).
 
d.  According to the batch production records collected during the inspection, the ingredient rebaudioside A is an ingredient in your Vanilla RecoveryWhey Protein product, but is not listed as an ingredient on the product label provided during the inspection. “Stevia,” which is not listed as an ingredient in the batch records, is declared as an ingredient on the label. We acknowledge that you are reformulating this product. Please be advised that in general, Rebaudioside A differs from Stevia in that it is a highly purified product. Products marketed as "Stevia" are whole leaf Stevia or Stevia extracts of which Rebaudioside A is a component.
 
e.  Your Fruit Punch Push Pre-Workout product label declares vitamin B3 which is not the nomenclature or synonym specified for niacin in 21 CFR 101.9 or 101.36(b)(2)(i)(B).
 
f.  Each of your Chocolate Pure Whey Protein, Strong Strength + Muscle, Push Pre-Workout, Fuel Whey Protein, Peppermint SO3 + D3 Fish Oil, and WSO3 Fish Oil products bears a statement of identity, “dietary supplement;” however, it is not in a size reasonably related to the most prominent printed matter on the principal display panel as required by 21 CFR 101.3(d).
 
g.  Your Peppermint SO3 + D3 Fish Oil product label and website for the WSO3 Fish Oil state that the products are “sugar free.” 21 CFR 101.13(e)(2) states that because the use of a “free” claim before the name of a food implies that the food differs from other foods of the same type by virtue of its having a lower amount of the nutrient, only foods that have been specially processed, altered, formulated, or reformulated so as to lower the amount of the nutrient in the food, remove the nutrient from the food, or not include the nutrient in the food, may bear such a claim. Any claim for the absence of a nutrient in a food, or that a food is low in a nutrient when the food has not been specially processed, altered, formulated, or reformulated to qualify for that claim shall indicate that the food inherently meets the criteria and shall clearly refer to all foods of that type and not merely to the particular brand to which the labeling attaches (e.g., “corn oil, a sodium-free food”).
 
h.  Your Coconut Fuel Whey Protein product label includes the symbol “**” next to the name of a the dietary ingredient MCTs (coconut fat) within the Supplement Facts label and the whey concentrate ingredient within the ingredient list. The “**”appears to refer to the allergen statement, “**Contains: milk, coconut” which is located beneath the ingredient statement. We note there are no provisions in 21 CFR 101.4 for the placement of a symbol adjacent to the common or usual name of an ingredient that may also link to a “Contains” statement. Furthermore, the symbol may be confusing to the consumer because it implies that both MCTs and whey concentrate are each a source of both milk and coconut.
 
Section 743 of the FD&C 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 noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations and to prevent similar violations from occurring in the future. 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.
 
Please send your reply to the Food and Drug Administration, Attention:  Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, 462 Welcome Center Road, Swanton, VT 05488. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or by email at scott.loughan@fda.hhs.gov.
 
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1
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