Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-casd-3_17-cv-00567/USCOURTS-casd-3_17-cv-00567-7/pdf.json

Nature of Suit Code: 370
Nature of Suit: Other Fraud
Cause of Action: 28:1332 Diversity Action

---

– 1 – 17cv0567

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF CALIFORNIA

ROSA ALVAREZ, on behalf of 

herself and all others similarly situated,

 Plaintiff,

Case No. 17-cv-00567-BAS-BGS

ORDER DENYING

DEFENDANTS’ MOTION FOR 

JUDGMENT ON THE 

PLEADINGS

[ECF No. 116]

v.

NBTY, INC., et al.,

 Defendants.

Plaintiff Rosa Alvarez brings a complaint against Defendants NBTY, Inc. and 

Nature’s Bounty, Inc. Plaintiff alleges Defendants have violated California’s unfair 

competition law (“UCL”); and Consumers Legal Remedies Act (“CLRA”).

Defendants previously moved for summary judgment, and Plaintiff moved for 

class certification—the Court denied both motions. (ECF Nos. 96, 97.) Defendants 

now move for judgment on the pleadings. (“Mot.,” ECF No. 116.) Plaintiff filed an 

opposition to the motion, (“Opp’n,” ECF No. 119), and Defendants filed a reply, 

(“Reply,” ECF No. 121).1

 1 Plaintiff requests the Court take judicial notice of three documents: Exhibits A, B, and C. (ECF 

No. 120.) Under Federal Rule of Evidence 201, courts can take judicial notice of facts that are not 

Case 3:17-cv-00567-BAS-BGS Document 122 Filed 01/03/20 PageID.<pageID> Page 1 of 6
– 2 – 17cv0567

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

The Court finds this motion suitable for determination on the papers 

submitted and without oral argument. See Civ. L.R. 7.1(d)(1). For the reasons 

stated below, this Court DENIES Defendants’ Motion.

I. BACKGROUND

Defendants manufacture, market, sell, and distribute biotin supplements under 

the Nature’s Bounty brand. (Second Amended Complaint, “SAC,” ECF No. 38, 

¶ 1.) The products at issue here are: Biotin 5000 mcg, SUPER POTENCY Biotin 

5000 mcg, QUICK DISSOLVE Biotin 5000 mcg, Biotin 10,000 mcg rapid release 

softgels, and Biotin 10,000 mcg HEALTH & BEAUTY rapid release liquid softgels

(hereinafter, “the Products”). (Id.) The Products’ labels state the Products 

“Support[] Healthy Hair, Skin, and Nails” and provide “Energy Support.” (Id. ¶ 20.) 

In approximately 2014, Plaintiff Rosa Alvarez’s hair began falling out. 

(“Alvarez Depo.,” Exhibit B of ECF No. 51-2, at 54:5–12.) Around this time, 

Plaintiff went to her regular nail salon for a manicure. The nail technician told her 

there was a supplement on the market that helps with hair and nails. (Id. at 66:3–15.) 

The nail technician took out his bottle of biotin, showed it to Plaintiff and others, and 

recommended taking the supplement in softgel form. (Id. at 68:4–15.) Plaintiff 

subsequently went to the store and purchased Defendants’ 10,000 mcg HEALTH & 

 

subject to reasonable dispute because they are either generally known or can be readily determined 

by reference to sources whose accuracy cannot reasonably be questioned. “When considering a 

motion for judgment on the pleadings, [a] court may consider facts that ‘are contained in materials 

of which the court may take judicial notice.’” Heliotrope Gen., Inc. v. Ford Motor Co., 189 F.3d 

971, 981 (9th Cir. 1999). “Judicial notice is appropriate for records and ‘reports of administrative 

bodies.’” United States v. 14.02 Acres of Land More or Less in Fresno Cty., 547 F.3d 943, 955 

(9th Cir. 2008).

All three documents are published on governmental agency websites. Defendants contest 

the proprietary of the Court taking judicial notice of Exhibit C, which is a study conducted by the 

Office of Inspector General of the Department of Health and Human Services. Defendants argue 

the study “dealt with different supplements and different issues from this case, and made contested 

factual findings in doing so.” (ECF No. 121, at 14.) The Court finds judicial notice of the study is 

not proper—just because a study was undertaken by a government agency does not mean that the 

accuracy of its conclusions “cannot reasonably be questioned.” The Court therefore takes judicial 

notice of only Exhibits A and B.

Case 3:17-cv-00567-BAS-BGS Document 122 Filed 01/03/20 PageID.<pageID> Page 2 of 6
– 3 – 17cv0567

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

BEAUTY rapid release liquid softgels biotin product. (Id.; SAC ¶ 15). She took 

biotin for a few years.

Plaintiff states she purchased the product “in reliance on Defendants’ health 

benefit representations.” (SAC ¶ 15.) She claims these representations are false, 

misleading, and reasonably likely to deceive the public. In sum, Plaintiff claims 

Defendants’ representations are false because the supplements do not support healthy 

hair, skin, and nails. (Id. ¶ 9.) “The human body only requires a finite amount of 

biotin on a daily basis for it to perform its enzymatic functions as there are a finite 

number of enzymes that use biotin. Once there is sufficient biotin in the body, 

saturation occurs and the body just does not use this surplus biotin.” (Id. ¶ 3.) The 

average person ingests more than enough biotin from his or her normal daily diet. 

(Id.) “Thus, biotin is not a ‘more is better’ substance, nor is more biotin needed from 

supplementation to complete these daily enzymatic functions.” (Id. ¶ 5.) “[O]nce 

one consumes a sufficient amount of biotin, which is easily met by the general 

population in their everyday diets, the remainder becomes functionally superfluous 

and does not convey any additional health benefits.” (Id.)

Plaintiff’s expert Dr. Wolf agrees that “the nutrient biotin plays a cellular and 

biochemical role in the support of healthy hair, skin, nails and energy.” (Wolf Depo, 

ECF No. 69-2, at 53:9–17.) But Dr. Wolf opines that Defendants’ Products (i.e. 

“mega-doses” of biotin) “do not provide any benefits to the general population and, 

thus, they do not help support healthy hair, skin and nails, or energy or energy 

production” and are “superfluous and unnecessary.” (“Wolf Report,” Exhibit D of 

ECF No. 51-2, at ¶ 11.) Due to “the metabolic characteristics of biotin, its availability 

from most food sources, and the finite needs of the human body for biotin,” one has 

no need for any biotin supplements, and Defendants’ Products are “worthless.” (Id.

¶ 12.) 

II. LEGAL STANDARD

“After the pleadings are closed—but early enough not to delay trial—a party 

Case 3:17-cv-00567-BAS-BGS Document 122 Filed 01/03/20 PageID.<pageID> Page 3 of 6
– 4 – 17cv0567

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

may move for judgment on the pleadings.” Fed. R. Civ. P. 12(c). A court ruling on 

Rule 12(c) motion for judgment on the pleadings applies the same standard used in a 

Rule 12(b)(6) motion to dismiss for failure to state a claim. Fleming v. Pickard, 581 

F.3d 922, 925 (9th Cir. 1996). The court must accept all factual allegations in the 

complaint as true and construe them in the light most favorable to the non-moving 

party. Id. “Judgment on the pleadings is proper when the moving party clearly 

establishes on the face of the pleadings that no material issue of fact remains to be 

resolved and that it is entitled to judgment as a matter of law.” Hal Roach Studios, 

Inc. v. Feiner & Co., Inc., 896 F.2d 1542, 1550 (9th Cir. 1989). It is the moving 

party’s burden to demonstrate that both of these requirements are met. Doleman v. 

Meiji Mut. Life Ins. Co., 727 F.2d 1480, 1482 (9th Cir. 1984). 

III. ANALYSIS

Defendants argue that Plaintiff’s claim that biotin supplements are 

unnecessary is preempted. The Food, Drug and Cosmetic Act (“FDCA”) expressly 

preempts any state law that imposes “any requirement respecting any claim of the 

type described in section 343(r)(1) of this title made in the label or labeling of food 

that is not identical to the requirement of section 343(r) of this title.” 21 U.S.C. § 

343-1(a)(5); Dachauer v. NBTY Inc., 913 F.3d 844, 847 (9th Cir. 2019). For dietary 

supplements, the FDCA distinguishes between “disease claims” and 

“structure/function claims” that manufacturers make about their products. A 

structure/function claim “‘describes the role of a nutrient or dietary ingredient 

intended to affect the structure or function in humans’ or ‘characterizes the 

documented mechanism by which a nutrient or dietary ingredient acts to maintain 

such structure or function.’” Dachauer, 913 F.3d at 846 (quoting 21 U.S.C. § 

343(r)(6)). Structure/function claims must meet three requirements: “(1) the 

manufacturer has substantiation that the statement is truthful and not misleading; (2) 

the statement contains a prominent disclaimer that the Food and Drug Administration 

(“FDA”) has not evaluated the statement and that the product ‘is not intended to 

Case 3:17-cv-00567-BAS-BGS Document 122 Filed 01/03/20 PageID.<pageID> Page 4 of 6
– 5 – 17cv0567

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

diagnose, treat, cure, or prevent any disease’; and (3) the statement itself does not 

‘claim to diagnose, mitigate, treat, cure, or prevent’ disease.” Id. at 847.2

In arguing preemption, Defendants rely heavily on Greenberg v. Target Corp., 

402 F. Supp. 3d 936 (N.D. Cal. 2019).

3

 The plaintiffs in Greenberg brought claims 

against Target regarding its biotin supplements. The label on Target’s supplements 

states: “Helps support healthy hair and skin” with asterisks at the end directing 

readers to a disclaimer: “This statement has not been evaluated by the Food and Drug 

Administration. This product is not intended to diagnose, treat, cure, or prevent any 

disease.” 402 F. Supp. 3d at 837. Plaintiff Greenberg alleged that the 

“structure/function claims regarding the Biotin Supplements are false and misleading 

based on evidence that any form of supplemental biotin is superfluous for the general 

public, i.e., has no effect on human structure or function.” Id. at 840. The court 

noted that it was undisputed that the nutrient Biotin “does indeed affect human 

structure or function” but the plaintiff’s argument was that although the nutrient 

affects structure/function, “the supplement at issue will impact the health of only a 

small proportion of the population.” Id. at 840–41. The court concluded,

“Greenberg identifies no federal regulation requiring a dietary supplement to 

substantiate its structure/function claims with evidence that the supplement, as 

opposed to the nutrient, will have the practical effect of impacting the health of a 

sizeable proportion of the general public.” Id. at 841. Therefore, his claims are 

preempted. Id.

Although Defendants here have not previously argued preemption (the main 

issue in Greenberg), they did argue that their products’ labels are not false or 

 2 “Although the FDCA requires manufacturers to have substantiation for their structure/function 

claims, California law does not allow private plaintiffs to demand substantiation for advertising 

claims. Instead, a private plaintiff bears the burden of producing evidence to prove that the 

challenged statement is false or misleading.” Dachauer, 913 F.3d at 847 (citations omitted).

3 The plaintiff in Greenberg was represented by the same attorneys as Plaintiff here, and both cases 

involve the same expert for the plaintiffs, Dr. Wolf. 

Case 3:17-cv-00567-BAS-BGS Document 122 Filed 01/03/20 PageID.<pageID> Page 5 of 6
– 6 – 17cv0567

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

misleading. (See generally ECF No. 51.) To successfully demonstrate preemption, 

Defendants must establish, inter alia, that the products are not false or misleading. 

See Hadley v. Kellogg Sales Co., 273 F. Supp. 3d 1052, 1072 (N.D. Cal. 2017) 

(holding the defendant has the burden of showing the plaintiff’s nutrient content or 

health claims are subject to preemption). The Court has already ruled on this issue, 

finding: 

A jury could conclude that a reasonable consumer would find 

Defendants’ Products misleading. Drawing all inferences from the 

underlying facts in the light most favorable to the Plaintiff, the Court 

finds there is a disputed issue as to whether reasonable consumer could 

believe that the high doses of biotin in Defendants’ Products support 

the consumer’s hair, skin, and nails, when, as Plaintiff presents, the 

biotin in one’s diet sufficiently supports hair, skin, and nails, and one 

does not need biotin from Defendants’ Products for such support.

(ECF No. 96, at 13.) Defendants are essentially asking the Court to reconsider this 

finding. And while it is true that the court in Greenberg found differently, this is not 

a basis for reconsideration. See Sch. Dist. No. 1J, Multnomah Cty. v. ACandS, Inc.,

5 F.3d 1255, 1263 (9th Cir. 1993) (holding reconsideration may be appropriate if 

there is “an intervening change in controlling law”). The Court finds no reason to 

change its prior ruling. Accepting all factual allegations in the Complaint as true and 

construing them in the light most favorable to Plaintiff, the Court finds that 

Defendants are not entitled to judgment as a matter of law.

IV. CONCLUSION

For the foregoing reasons, the Court DENIES Defendants’ Motion for 

Judgment on the Pleadings. Pursuant to the recent order by Judge Skomal, (ECF No. 

110), the parties are to contact Judge Skomal’s chambers within 3 court days of the 

date of this Order to schedule a mandatory settlement conference.

IT IS SO ORDERED.

DATED: January 3, 2020

Case 3:17-cv-00567-BAS-BGS Document 122 Filed 01/03/20 PageID.<pageID> Page 6 of 6